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| Sponsor: | Ministry of Science and Technology of the People´s Republic of China |
|---|---|
| Collaborator: |
University of California, San Francisco |
| Information provided by: | Ministry of Science and Technology of the People´s Republic of China |
| ClinicalTrials.gov Identifier: | NCT00979589 |
Purpose
The purpose of this study is to assess the effects of a 3-month regimen of clopidogrel initiated with a loading dose (LD) of 300 mg followed by 75 mg/day during the first 21days versus a 3-month regimen of ASA 75 mg/day alone on reducing the 3-month risk of any stroke (both ischemic and hemorrhagic, primary outcome) when initiated within 24 hours of symptom onset in high-risk patients with TIA or minor stroke.
| Condition | Intervention | Phase |
|---|---|---|
|
Stroke Transient Ischemic Attack |
Drug: Clopidogrel Drug: Placebo of clopidogrel and Asprin |
Phase III |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Randomized,Double-blind Trial Comparing the Effects of a 3-month Clopidogrel Regimen,Combined With ASA During the First 21days,Versus ASA Alone for the Acute Treatment of TIA or Minor Stroke |
| Estimated Enrollment: | 5100 |
| Study Start Date: | July 2008 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Combination Clopidogrel and asprin: Active Comparator |
Drug: Clopidogrel
The first group will receive a 300mg loading dose (LD) of clopidogrel on the day of randomization, followed by 75 mg clopidogrel/day from Day 2 to 3 months. ASA will be given in a total dose ranging between 75 mg and 300 mg (open label) on the first day, followed by blinded 75 mg once /day from Day 2 to Day 21st. Between Day 21st and 3-month visits, ASA 75 mg will be replaced by a placebo of ASA 75 mg.
|
| Asprin and placebo: Placebo Comparator |
Drug: Placebo of clopidogrel and Asprin
The second group will receive open label ASA in a total dose ranging between 75 mg and 300 mg on the first day, followed by blinded 75 mg once /day from Day 2 to 3 months. A placebo for clopidogrel will be given from the day of randomization until the 3-month visit.
|
Inclusion criteria:
Primary Efficacy Endpoint:
Percentage of patients with the 3-month new vascular events, defined as any event of the following:Any stroke (ischemic or hemorrhage).
Eligibility| Ages Eligible for Study: | 40 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion Criteria:
Contacts and Locations| Contact: yilong Wang, M.D | 00861067013383 | yilong528@gmail.com |
| Contact: xia Meng, M.D | 00861067096699 | mengxia45@163.com |
| China | |
| Beijing Tian Tan Hospital, Capital Medical University | Recruiting |
| Beijing, China, 100050 | |
| Contact: Yilong Wang, M.D 00861067013383 yilong528@gmail.com | |
| Contact: Xia Meng, M.D 00861067093383 mengxia45@163.com | |
| Principal Investigator: Yongjun Wang, M.D | |
| Principal Investigator: Claiborne Johnston, M.D, Ph.D | |
| Principal Investigator: | Yongjun Wang, M.D | Beijing Tian Tan Hospital, Capital Medical University, Beijing, China |
| Principal Investigator: | S.Claiborne Johnston, M.D, Ph.D | Departments of Neurology, Epidemiology, University of California, San Francisco, USA |
More Information
| Responsible Party: | Beijing Tian Tan Hospital, Capital Medical University, China ( Yongjun Wang ) |
| Study ID Numbers: | 2008ZX09312-008 |
| Study First Received: | September 17, 2009 |
| Last Updated: | January 20, 2010 |
| ClinicalTrials.gov Identifier: | NCT00979589 History of Changes |
| Health Authority: | The people's republic of China: The Ministry of Science and Technology |
|
stroke transient ischemic attack acute treatment acute non-disabling cerebrovascular event |
clopidogrel clopidogrel combined with ASA recurrence of stroke and other vascular events |
|
Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Cerebral Infarction Hematologic Agents Physiological Effects of Drugs Fibrinolytic Agents Brain Diseases Cerebrovascular Disorders Fibrin Modulating Agents Aspirin Sensory System Agents Therapeutic Uses Brain Ischemia Cardiovascular Diseases Anti-Inflammatory Agents, Non-Steroidal |
Analgesics Ischemic Attack, Transient Ticlopidine Cyclooxygenase Inhibitors Nervous System Diseases Stroke Vascular Diseases Central Nervous System Diseases Enzyme Inhibitors Cardiovascular Agents Pharmacologic Actions Analgesics, Non-Narcotic Clopidogrel Platelet Aggregation Inhibitors Brain Infarction |