|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | yongjun wang |
|---|---|
| Collaborator: |
University of California, San Francisco |
| Information provided by (Responsible Party): | yongjun wang, 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 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| 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 |
| Enrollment: | 5100 |
| Study Start Date: | July 2008 |
| Study Completion Date: | March 2012 |
| Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Combination Clopidogrel and asprin |
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.
Other Name: Plavix
|
| Placebo Comparator: Asprin and placebo |
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.
Other Name: Acetylsalicylic acid
|
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| China | |
| Beijing Tian Tan Hospital, Capital Medical University | |
| Beijing, China, 100050 | |
| Principal Investigator: | Yongjun NA Wang, M.D | Beijing Tian Tan Hospital, Capital Medical University, Beijing, China |
| Principal Investigator: | S.Claiborne NA Johnston, M.D, Ph.D | Departments of Neurology, Epidemiology, University of California, San Francisco, USA |
More Information
| Responsible Party: | yongjun wang, Vice president of Beijing Tiantan Hospital, Ministry of Science and Technology of the People´s Republic of China |
| ClinicalTrials.gov Identifier: | NCT00979589 History of Changes |
| Other Study ID Numbers: | 2008ZX09312-008 |
| Study First Received: | September 17, 2009 |
| Last Updated: | March 11, 2012 |
| 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 |
|
Ischemic Attack, Transient Ischemia Stroke Cerebral Infarction Brain Ischemia Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases Pathologic Processes Brain Infarction Aspirin Ticlopidine |
Clopidogrel Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents |