Status:
COMPLETED
Clopidogrel in High-risk Patients With Acute Non-disabling Cerebrovascular Events
Lead Sponsor:
Beijing Tiantan Hospital
Collaborating Sponsors:
University of California, San Francisco
Conditions:
Stroke
Transient Ischemic Attack
Eligibility:
All Genders
40-90 years
Phase:
PHASE3
Brief Summary
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 regim...
Detailed Description
Inclusion criteria: 1. Adult subjects (male or female ≥ 40 years) 2. Acute non-disabling ischemic stroke (NIHSS≤3 at the time of randomization) that can be treated with study drug within 24 hours of ...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Adult subjects (male or female≥40 years)
- Acute non-disabling ischemic stroke (NIHSS≤3 at the time of randomization) that can be treated with study drug within 24 hours of symptoms onset. Symptom onset is defined by the "last see normal" principle
- TIA (Neurological deficit attributed to focal brain ischemia, with resolution of the deficit within 24 hours of symptom onset), that can be treated with study drug within 24 hours of symptoms onset and with moderate-to-high risk of stroke recurrence (ABCD2 score≥4 at the time of randomization).Symptom onset is defined by the "last see normal" principle
- Informed consent signed
- Exclusion Criteria:
- Diagnosis of hemorrhage or other pathology, such as vascular malformation, tumor, abscess or other major non-ischemic brain disease (e.g., multiple sclerosis) on baseline head CT or MRI
- Isolated or pure sensory symptoms (e.g., numbness), isolated visual changes, or isolated dizziness/vertigo without evidence of acute infarction on baseline head CT or MRI
- Modified Rankin Scale Score\>2 at randomization (pre-morbid historical assessment)
- NIH Stroke Score≥4 at randomization
- Clear indication for anticoagulation(presumed cardiac source of embolus, e.g., atrial fibrillation, prosthetic cardiac valves known or suspected endocarditis)
- Contraindication to clopidogrel or ASA
- Known allergy
- Severe renal or hepatic insufficiency
- Severe cardiac failure, asthma
- Hemostatic disorder or systemic bleeding
- History of hemostatic disorder or systemic bleeding
- History of thrombocytopenia or neutropenia
- History of drug-induced hematologic or hepatic abnormalities
- Low white blood cell (\<2 x109/l) or platelet count (\<100 x109/l)
- Use of thrombolysis within 24 hours prior to randomization
- History of intracranial hemorrhage
- Anticipated requirement for long-term non-study antiplatelet drugs, or NSAIDs affecting platelet function
- Current treatment (last dose given within 10 days before randomization) with heparin therapy or oral anti coagulation
- Gastrointestinal bleed or major surgery within 3 months
- Planned or likely revascularization (any angioplasty or vascular surgery) within the next 3 months (if clinically indicated, vascular imaging should be performed prior to randomization whenever possible)
- Scheduled for surgery or interventional treatment requiring study drug cessation
- Qualifying TIA or minor stroke induced by angiography or surgery
- Severe non-cardiovascular comorbidity with life expectancy \< 3 months
- Women of childbearing age not practicing reliable contraception who do not have a documented negative pregnancy test
- Currently receiving an investigational drug or device
Exclusion
Key Trial Info
Start Date :
December 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
5100 Patients enrolled
Trial Details
Trial ID
NCT00979589
Start Date
December 1 2009
End Date
June 1 2012
Last Update
July 15 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Beijing Tian Tan Hospital, Capital Medical University
Beijing, China, 100050