What other choices do I have if I do not take part ... - NETT
UNIVERSITY OF CALIFORNIA, SAN FRANCISCOSAN FRANCISCO GENERAL HOSPITALCONSENT TO PARTICIPATE IN A RESEARCH STUDYStudy Title: Platelet-Oriented Inhibition in New TIA and minor ischemic strokeMinor Ischemic Stroke (POINT Trial)This is a medical research study. Your study doctor, Claude Hemphill, MD, MAS, or a POINT study doctor or coordinator will explain this study to you.Medical research studies include only people who choose to take part. Take your time to make your decision about participating. You may discuss your decision with your family and friends and with your health care team. If you have any questions, you may ask your study doctor.You are being asked to participate in this research study because you have just had a transient ischemic attack (TIA) or a minor stroke. A TIA is a condition that produces stroke-like symptoms like sudden weakness on one side of the body or trouble speaking, but the symptoms are temporary. Why is this study being done?The purpose of this study is to determine the safety and effectiveness of the combination of low-dose aspirin and a medication called clopidogrel (also known by the brand name Plavix?) in reducing the risk of stroke, heart attacks and other complications in patients who have just had a TIA or minor ischemic stroke. Patients who have had a TIA have a higher risk of developing a stroke. Recognizing and treating TIAs can reduce your risk of a stroke. Often, medication to prevent blood clots from forming is used to prevent a stroke in patients with blockage of one of the arteries in the brain. Low-dose aspirin has been shown to be effective in preventing strokes and heart attacks in patients who have had a TIA. Clopidogrel is another medication that is used to prevent strokes and heart attacks in patients at risk for these problems. Clopidogrel is a type of medication called an antiplatelet drug, and it works by helping to keep platelets (small blood cells needed for normal blood clotting) in the blood from sticking together and forming harmful blood clots. This helps your blood flow more easily, and provides more protection against a future heart attack or stroke. Clopidogrel is approved for the prevention of a second stroke, and is taken once per day. Aspirin has also been shown to be effective in helping to prevent a second stroke or TIA, and is approved in doses ranging from 50 to 325 mg per day.Several studies that tested the combination of clopidogrelclopidrogrel and aspirin have shownsuggested that taking these two medications together may protect patients even more from major stroke and heart attack after a TIA or minor stroke, in comparison to taking aspirin alone., but these studies were small and the risk of bleeding was increased. The POINT research studytrial has been designed to find out whether the combination of aspirin and clopidogrel reduces the risk of stroke, heart attacks and other complications compared to aspirin alone in patients like you. A single trial in China studying patients with stroke and TIA suggested that the combination of clopidogrel and aspirin was safe and effective.?However, there are differences in the treatment of patients, the types of stroke, and the design of the trial, so it is not clear whether these results would apply to you.This study is sponsored by the National Institutes of Health (NIH) and the National Institute of Neurological Disorders and StrokesStroke (NINDS).How many people will take part in this study?A total of 41505,840 patients in about 210350 hospitals will participate in this research study, with about 100 people enrolled at UCSF and SFGH. What will happen if I take part in this research study?Before you begin the main part of the study...If you agree to take part in this study and sign this consent, you will be assessed at the hospital to see if you meet the entry criteria for the study. In addition to the tests and exams performed as part of your routine care, your treating doctorphysician will also check whether or not you are eligible to participate in the study by performing the following:A complete physical examination and medical history, including any medications you are currently taking, since there are some medications you cannot take while you are in this study.A neurologicalNeurological evaluation using either the NIH Stroke Scale (NIHSS) or the ABCD2 score.(If you have already had a physical examination and neurological assessment as part of your routine care, they may not need to be repeated for the study. If they were not done, or need to be repeated, the examination and neurological assessment will be done at no cost to you.)If you are female and not post-menopausal or have not had a prior hysterectomy, you will undergo a blood or urine test to determine if you are pregnant. The drugs in this study can affect a fetus, so pregnant women may not participate in this study. You may not be enrolled in this study until all of these tests and procedures have been completed, and a study doctor has reviewed the results.During the main part of the study…After those procedures are completed, and it has been determined that you are eligible for this study, you will be randomly assigned to one of the two groups described below. Randomization means that you are put into a group by chance. You will have an equal chance of being placed in one of the two groups.This is a double-blind study, which means that neither your study doctor nor you will know which of the study drug groups you will be randomly assigned to. However, this information will be available in the case of an emergency. Group 1: If you are assigned to this group, you will take a loadingan initial dose of 600mg of clopidogrel600 mg of clopidogrel on the first day of your participation in the study (8 tablets of 75mg75 mg each) and then you will take 75mg75 mg (1 tablet) of clopidogrel each day for the next 89 days. You will also take 50-325 mg of aspirin each day for 90 days; the dose of aspirin will be determined by your treating physician.orORGroup 2: If you are assigned to this group, you will take an initial dose of 8 tablets of placebo, a tablet containing an inactive substance, on the first day of your participation in the study, and then 1 tablet of placebo each day for the next 89 days. You will also take 50-325 mg of aspirin each day for 90 days; the dose of aspirin will be determined by your treating physician.Just before your discharge from the hospital, an appointment for your next visit in about 90 days will be made and information about how to contact your study doctor in case of an emergency will be given to you. You will also be given a list of medications to be avoided while taking study medication as well as a study medication log and study information sheet. You will be asked for your contact information, such as your email address and any alternative contacts, so that we can keep in touch with you throughout the study. You can choose not to provide alternative contacts. Study Visits: One WeekAbout 1 week after your first dose, the Study Coordinator will call you or ask you in person whether you’ve been taking your study medications, and collect information about any side effects or possible eventsadverse events (any undesirable experiences associated with the use of the study medication) you might be experiencing. The Coordinator will also collect information about your other medications and will ask you to complete a short survey about any neurological symptoms you may have had since your discharge.30 Day Telephone ContactAbout 30 days after your first dose, the Study Coordinator will contact you to assess your condition, ask you whether you’ve been taking your study medications, and whether you are experiencing any side effects or other possibleadverse events. Event VisitIf it is thought that, based on information you provide, you might have had a stroke, a TIA or a heart attack, you will be scheduled for an evaluation. IfAt the visit is done in-person, you will:have your blood pressure and heart rate checkedhave tests performed as part of your regular care, including a CT or MRI of your head, an ECG and blood testsanswer any questions about your study medications and any side effects or adverse eventsbe evaluated using bothtwo scales, the modified Rankin Scale (mRS) and the NIH Stroke Scale (NIHSS, which are commonly used after TIA and stroke)have your blood pressure taken complete the Stroke-Free and the Morisky Questionnaires, which are surveysanother survey about any neurological symptoms you may have had since enrolling in the study .If the visit is done by telephone, you will:answer questions about your study medications and any side effects or adverse eventsbe evaluated using the modified Rankin Scale complete the Stroke-Free and the Morisky Questionnaires90 Days90 Day Visit or Telephone Contact You will haveneed to return to SFGH for a study visit 90 days after starting the study; this. At the follow-up visit you will be done either in person or by telephone. :If the visit is conducted in-person, you will:have your blood pressure and heart rate checked answer questions about your study medications and any side effects or adverse eventsbe evaluated using the modified Rankin Scale (mRS) and the NIH Stroke Scale (NIHSS)complete the Stroke-Free and the Morisky Questionnaires Other tests may be performed as part of your regular care, including a CT or MRI of your head, an ECG and blood tests. have your blood pressure taken complete another survey about any neurological symptoms you may have had since enrolling in the studyIf the visit is done by telephone, then you will:answer questions about your study medications and any side effects or adverse eventsbe evaluated using the modified Rankin Scale complete the Stroke-Free and the Morisky QuestionnairesAt the end of the study, your treating physician will discuss with you the best choice for antiplatelet drugs like those in the study.? Depending on costs, side effects, and your own preferences, clopidogrel, aspirin, or the medication aspirin/dipyridamole (also known as Aggrenox?) may be the best choice.If for some reason we are unable to locate you for the 90 -Day follow up visit, we will ask your alternate contact and/or review your medical chart to find out if you have been seen by another doctor within your hospital system and if you have had a stroke, TIA, or heart attack during the 90-Day follow up period. In order to make sure that we include the full 90-Day period in our review, we will need to review your chart after the 90 day study period has ended. This means that we may continue to collect information about you up to 150 days from your enrollment.How long will I be in the study? The total length of your participation in this study is approximately 3 months. The amount of time needed to evaluate you and assign you to a treatment group is about 2 hours. The telephone follow-up at day 7 will take about 15 minutes. The telephone contact at day 30 will take about 15 minutes. The follow-up visit at 90 days after your discharge from the hospital will take about 1 hour or less if completed by telephone. About 2 hours will be needed if you are scheduled for an in-person evaluation. If a telephone evaluation is conducted, it will take about 15 minutes. Therefore, a total of about 34-5 additional hours of participation will be needed after you are discharged from you if you join the hospitalstudy. About 2 hours will be needed if you are scheduled for an evaluation because it is thought that you might have had a stroke, TIA or heart attack.About five months after you’ve joined the study, the researchers will no longer collect information about you. If you decide that you want the researchers to stop collecting information about you before then, then you must withdraw your permission by writing to the study doctor listed on the first page of this form. The researchers will continue to use the information that they have collected about you up until that point.Can I stop being in the study?Yes. You can decide to stop at any time. Tell the study doctor if you are thinking about stopping or decide to stop. He or she will tell you how to stop your participation safely. It is important to tell the study doctor if you are thinking about stopping so that your study doctor can evaluate any risks from the study drugs, and discuss what alternative follow-up care and testing could be most helpful for you. If you decide to stop participating or are withdrawn from the study, information about whether you had a stroke, heart attack or other complication during the 90 days of the study will still be helpful to the research. Giving consent will allow study personnel to collect this information by asking you or your alternative contact on the phone, asking you in-person, accessing your medical record and/or performing a chart review for up to 150 days from your enrollment.The study doctor may stop you from taking part in this study at any time if he/she believes it is in your best interest, if you do not follow the study rules, or if the study is stopped. The entire study could also be stopped on the recommendations of a safety committee that will monitor this study or by the sponsors of the study. What side effects or risks can I expect from being in the study?You may have side effects while on the study. Everyone taking part in the study will be watched carefully for any side effects. However, not all the side effects that may happen are known. Side effects may be mild or very serious. Your health care team may give you medicines to help lessen side effects. Many side effects go away soon after you stop taking the study drugs; in some cases, side effects can be serious, long lasting, or may never go away. You should talk to your study doctor about any side effects you experience while taking part in the study. Risks and side effects include:Risks and side effects include:Randomization: You will be randomly assigned to a study group, with an equal (50:50) chance of being assigned to a study group. The treatment you receive may prove to be less effective or to have more side effects than the other study treatment or than other available treatments. This will not be known until after the study is completed and the data have been analyzed. Placebo risks: If you are in the group that receives placebo, your condition will go without the active (study) treatment for about 12 weeks. Side effects from study drugs: All medications have possible risks and side effects, even those that have been approved by the US Food and Drug Administration (FDA). Known side effects of each of the study medications are listed below. Patients who have a known hypersensitivity (allergic reaction) to any of the study medications should not participate in this study. Side effects from clopidogrel: Clopidogrel works by thinning the blood in order to help blood flow more easily. Since blood clotting may take longer than normal while you’re taking clopidogrel, you may experience longer bleeding from cuts, and you may also bruise more easily. You should tell Dr. Hemphill or the researchyour study coordinatordoctor promptly if you experience any unexplained bruising or unusual bleeding (e.g., bleeding from an unusual site or that takes a very long time to stop), particularly if also accompanied by a fever, signs of infections, extreme tiredness or feeling generally unwell. Superficial and internal bleeding, including bleeding into the brain, are also side effects of clopidogrel; internal bleeding and bleeding into the brain are serious conditions that can result in death.The most common side effects of clopidogrel include abdominal or stomach pain, diarrhea, skin reactions (rash, itching), aching muscles and/or joints, dizziness, fever, headache and a decrease in the number of a type of white blood cell called a neutrophil. In rare cases, clopidogrel may cause stomach bleeding; symptoms of stomach bleeding include darker (sometimes black), tarry stools and stomach pain. There have also been rare reports of a serious bleeding disorder called thrombotic thrombocytopenic purpura (TTP) associated with clopidogrel; this side effect is most likely to occur during the first two weeks of treatment. During the trial, you must immediately tell Dr. Hemphill or the researchyour study coordinatordoctor about any abnormal or unexpected events and in particular about any warning sign of brain attack (feeling weak, or numb on one side, blurry vision, or no vision usually in one eye, unable to talk clearly, dizziness or falling, or severe headache), any anginal pain (chest pain during rest or exercise), any bleeding (overt bleeding, spontaneous bruise), infection (fever, shivering, sore throat), skin rash, severe diarrhea, or jaundice (yellow discoloration of the skin). If you are hospitalized in a hospital where the study doctor does not work, whatever the reason is, you (or one of your relatives) must inform Dr. Hemphill or the researchyour study coordinatordoctor as soon as possible. You must also tell your primary care doctor that you are taking part in this study. Side effects from aspirin: Aspirin has two main types of side effects: it can cause gastrointestinal upset and it can increase bleeding. The most common side effects associated with aspirin use are gastrointestinal-related, and include stomach pain, heartburn, nausea and/or vomiting. In rare cases, more serious effects, such as bleeding, have been observed in individuals taking aspirin for extended periods of time. Even less commonly, hemorrhagic stroke (bleeding in the brain) can occur. The side effects of aspirin are generally dose-related, and tend to occur more often in doses that are higher than the dose of aspirin taken in this study.Side effects from aspirin and clopidogrel: The biggest risk in this study is hemorrhagebleeding resulting from the combination of aspirin and clopidogrel. This combination has not been tested right after a TIA or minor ischemic stroke, so rates of bleeding must be estimated from other studies of stroke and acute coronary syndromes such as heart attack and unstable angina or chest pain. It is likely, based on the results of those studies, that clopidogrel combined with aspirin is associated with a slightly higher risk of major bleeding. The combination of aspirin and clopidogrel may increase the risk of complications with surgeries or other procedures, such as endarterectomy (a surgical procedure to remove material called plaque from inside an artery), or may delay the performance of these procedures due to concerns about bleeding risk; a delay could increase your risk of stroke.Side effects from discontinuing medications for study purposes: If you are currently taking a drug that blocks platelets (such as clopidogrel or dipyridamole) or blocks clotting (such as warfarin), this drug will be stopped before you enter the study; if. If you have a reason to be on one of these specific drugs, your doctor will not enroll you in this trial. Also, some doctors treat patients with TIA with clopidogrel and aspirin together. In this trial, there is a risk that you will receive weaker drugs than you would have gotten otherwise, and this could increase your risk of having a stroke but it could also reduce your risk of bleeding. This will not be known until after the study is completed and the data have been analyzed.Taking other medications while on the study: Certain medications may make clopidogrel less effective. If you receive any new prescriptions while you are on the study, you should tell the study doctor. Risks of blood draws: The risks and discomforts of drawing blood include temporary discomfort from the needle stick, the possibility of pain or bruising at the site of the blood draw, occasional feelings of lightheadedness and, rarely, infection at the site of the blood draw.Pregnant or nursing females: If you are a woman of childbearing potential, you must not be pregnant and/or currently nursing a child, and you must use an acceptable method of birth control to avoid pregnancy while on this study. Acceptable methods of birth control include hormonal contraceptives, intrauterine device, abstinence, or spermacide and barrier, or abstinence. . If you should become pregnant while on this study, you should notify your study doctor immediately.Confidentiality: Participation in research will mean a loss of confidentiality, but information about you will be handled as confidentially as possible. 6. 5. Unknown Risks: The experimental treatments may have side effects that no one knows about yet. The researchers will let you know if they learn anything that might make you change your mind about participating in the study. For more information about risks and side effects, ask your study doctor.Are there benefits to taking part in the study?There is no guarantee that you will benefit from joining this study. If you are in the group that receives clopidogrel and it proves to treat your condition more effectively and with fewer side effects than the placebo, you may benefit from your participation.Your participation in the study may help the investigators better understand the safety and effectiveness of clopidogrel when used with aspirin to prevent stroke in patients with a TIA or a minor ischemic stroke, and the knowledge gained from participation in this research study may help other patients with TIA or minor ischemic stroke in the future.What other choices do I have if I do not take part in this study?You do not have to be in this study to be treated for your condition. If you do not want to join this study, you will get the usual therapies that your treating physician prescribes following a TIA or minor ischemic stroke. There are several drugs approved by the FDA for the prevention of a stroke, including aspirin and clopidogrelclopodigrel. Aspirin is available without a prescription, and clopidogrel is available off the study; your primary care doctor may prescribe aspirin and clopidogrel together to treat your condition. Other drugs are available to you by prescription from your primary care doctor without participating in this study. You may also choose not to receive any treatment. You may wish to discuss your treatment options with your primary care doctor before you decide to participate in this study. Will my medical information be kept private?Participation in research will mean a loss of confidentiality, but information about you will be handled as confidentially as possible. We will do our best to make sure that the personal information in your medical record is kept private. However, we cannot guarantee total privacy. Your personal information may be given out if required by law. If information from this study is published or presented at scientific meetings, your name and other personal information will not be used.The study doctors and researchers conducting this study, health care workers providing services to you in connection with the study and the University of California San Francisco (UCSF) Committee on Human Research (CHR) will have access to the study records. In addition, representatives from the NIH/NINDS, NINDS Clinical Research Collaboration (CRC) Operations Center, Neurological Emergencies Treatment Trials (NETT) Network (University of Michigan), the Statistical Data Management Center (SDMC;), and the Medical University of South Carolina) and the FDA (MUSC) may review information about you to check on the study. If you sign this consent form, you are allowing the study sponsor, the University of California San Francisco (UCSF), and the FDA to review your medical records. Your name will not be used in any published reports about this study, and you will only be identified by a number in study records. Paper records will be kept in a locked file cabinet in a secure room, and computerized records will be kept on a secure server accessible only by authorized members of the study team. At your request, information collected about you from your participation in this study will be given to your primary care doctor. A UCSF or SFGHA medical record may be created as a result of your participation in this study. Your consent form and some of your test results would be included in this record. Therefore, your other SFGH doctors may become aware of your participation. Hospital regulations require that all health care providers treat information in medical records confidentially. What are the costs of taking part in this study? You and/or your insurance company will be responsible for payment of all medical costs that are not related to the study, any co-payments or deductibles required under your insurance for any unrelated tests and procedures, and for routine follow-up imaging and clinical examinations. The study drugs and all follow-up visits to the study doctors will be paid for by the study. Will I be paid for taking part in this study?You will not be paid for taking part in this study.What happens if I am injured because I took part in this study? It is important that you tell your study doctor, Dr.Claude Hemphill, MD, MAS if you feel that you have been injured because of taking part in this study. You can tell the study doctor in person or call him at 415-206-3213 (Dr. Hemphill)..Treatment and Compensation for Injury: If you are injured as a result of being in this study, the University of California will provide necessary medical treatment will be available.. The costs of the treatment may be billed to you or your insurer just like any other medical costs, or covered by the University of California or the study sponsor, the National Institutes of Health (NIH) and the National Institute of Neurological Disorders and Strokes (NINDS),, depending on a number of factors. The University and the study sponsor dodoes not normally provide any other form of compensation for injury. For further information about this, you may call the office of the Committee on Human Research at 415- 476-1814. What are my rights if I take part in this study?Taking partYour participation in this study is your choice.entirely voluntary. You may choose either to take part ofor not to take part in the study. If you decide to take part in this study, you may leave the study at any time. Data that were already collected while you were in the study will continue to be used. Also, data that are required by the FDA to monitor the safety of the study drug will still be collected, such as adverse events.No matter what decision you make, there will be no penalty to you and you will not lose any of your regular benefits. Leaving the study will not affect your medical care. You can still get your medical care from our institution.We will tell you about new information or changes in the study that may affect your health or your willingness to continue in the study. To withdraw for any reason, you have to notify the study doctor or the study staff. You can notify them in writing, or by calling and telling one of the study staff you no longer want to participate. The study doctor may stop you from taking part in this study at any time if he/she believes it is in your best interest, if you do not follow the study rules, or if the study is stopped. The entire study could also be stopped on the recommendations of a safety committee that will monitor this study or by the sponsors of the study. In the case of injury resulting from this study, you do not lose any of your legal rights to seek payment by signing this form.A description of this research study is available on HYPERLINK "" , as required by U.S. law. This website does not include information that can identify you; at most, the website will include a summary of the study results. You can search this website at any time.Who can answer my questions about the study?You can talk to your study doctor about any questions, concerns, or complaints you have about this study. Contact your study doctor, Claude Hemphill, MD, MAS at (415) -206-3213. You can also call the study nurse, Michele Meeker, RN at 415-206-3220. For questions about your rights while taking part in this study, call the office of the Committee on Human Research, UCSF’sUCSF Institutional Review Board (a group of people who review the research to protect your rights), at 415-476-1814.Optional POINT Biomarkers Ancillary StudyIf you take part in the main study, you will also be asked for an optional one-time blood sample as part of an ancillary, or secondary, study of biomarkers. Biomarkers are molecules found in blood, other body fluids, or tissues that are signs of a specific condition or disease. If you agree to participate in the secondary study, we will collect about 2 teaspoons of blood (two 5approximately 10 mL tubes) from you for a type of test called a “biomarker test” on your blood. The biomarker test will help us learn if you have specific biomarkers for the genes named ABCB1 and CYP2C19 which may affect how your body responds to being treated with clopidogrel, the medication being studied in this trial. The results of the biomarker tests can help us learn more about how effective clopidogrel can be for preventing stroke in people who have had a TIA and also have those specific biomarkers in their blood. The blood will be prepared for genetic analysis and stored at the Neurogenetics Laboratory at the Mayo Clinic in Jacksonville, Florida (MCF) for 20 years. The stored blood samples may be used in future studies for TIA and stroke. We will do our best to make sure that the personal information that we have collected is kept private. We will assign numbers to label the blood samples and no personal information will be on the tubes used to store the blood samples. The genetic test results will be provided to the Principal Investigator and statistician in the study.?You will not receive the genetic test results.The secondary study is optional and you can decide to participate in just the main study. You can decide to stop participating in the secondary study at any time by letting your study doctor know and your blood sample will be destroyed. CONSENTYou have been given copies of this consent form and the Experimental Subject's Bill of Rights to keep.You will be asked to sign a separate form authorizing access, use, creation, or disclosure of health information about you.PARTICIPATION IN RESEARCH IS VOLUNTARY. You have the right to decline to participate or to withdraw at any point in this study without penalty or loss of benefits to which you are otherwise entitled.If you wish to participate in this study, you should sign below.____________________________________ ______________________________ Subject's signatureDate____________________________________ ______________________________ Signature of person obtaining consentDateAlternative ContactsYESNOPlease indicate whether you wish to allow alternative contacts to be contacted regarding your participation in this study by entering your initials in the “Yes” or “No” box to the right.Optional Ancillary (Secondary) StudyPlease indicate whetherif you wish to also participate in the optional ancillary study by reading each sentence below and entering your initials in the "Yes" or "No" box. If you have any questions about the optional ancillary study, please talk to the study doctor or nurse. No matter what you decide to do, it will not affect your care.YESNOMy blood sample may be taken for this research, as described in the Optional POINT Biomarkers Ancillary Study section above.YESNOMy blood sample may be kept for use in research to learn about biomarkers related to TIA and stroke.You have been given copies of this consent form and the Experimental Subject's Bill of Rights to keep. You will be asked to sign a separate form authorizing access, use, creation, or disclosure of health information about you.PARTICIPATION IN RESEARCH IS VOLUNTARY. You have the right to decline to participate or to withdraw at any point in this study without penalty or loss of benefits to which you are otherwise entitled.If you wish to participate in this study, you should sign below.____________________________________ ______________________________ Subject's signatureDate___________________________________ ______________________________ Signature of person obtaining consentDateAlternative ContactsYESPlease place your initials in the “YES” box to the right, if you agree to allow study team members to contact your alternative contacts to discuss your participation in this study and find out how you are doing at the 90 Day visit, if we are unable to reach you. ................
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