high-risk non-disabling ischemic cerebrovascular events
Conditions
Interventions
90d group:a loading dose of 300 mg of clopidogrel on day 1, followed by a dose of 75 mg per day on days 2 through 90
21d group:a loading dose of 300 mg of clopidogrel on day 1, followed by a dose of 75 mg per day on days 2 through 21, and placebo clopidogrel on days 22 through 90. and aspirin at a dose of 100mg per
Sponsors
Department of Neurology, Shuyang People's Hospital
Eligibility
Sex/Gender
All
Age
40 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. aged 40 years or older; 2. Diagnosis of a High-risk non-disabling ischemic cerebrovascular events(HR-NICE), include TIA with moderate to high risk of stroke recurrence (ABCD2 score =4 at the time of randomization), minor stroke with acute multiple infarction lesions and/or intracranial/extracranial large artery atherosclerotic stenosis ?50%; 3. Ability to start the study drug within 24 hours after symptom onset, which was defined as the point at which the patient reported no longer being in a normal condition; 4. Informed consent.
Exclusion criteria
Exclusion criteria: 1. Diagnosis of hemorrhage or other pathology, such as vascular malformation, tumor, abscess or other major nonischemic brain disease (eg, multiple sclerosis), on baseline head CT or MRI; 2. Isolated or pure sensory symptoms (eg, numbness), isolated visual changes, or isolated dizziness/vertigo without evidence of acute infarction on baseline head CT or MRI; 3. clear indication for anticoagulation therapy (presumed cardiac source of embolus, such as atrial fibrillation or prosthetic cardiac valve); 4. mRS score >2 at randomization (premorbid historical assessment); 5. Contraindication to clopidogrel or aspirin: (1) Known allergy; (2) Severe renal or hepatic insufficiency; (3) Severe cardiac failure, asthma; (4) Hemostatic disorder or systemic bleeding; (5) History of hemostatic disorder or systemic bleeding; (6) Low white blood cell (<2×10^9/L) or platelet count (<100×10^9/L); (7) Use of thrombolysis within 24h before randomization. 6. History of intracranial hemorrhage; 7. Anticipated requirement for long-term non study antiplatelet drugs, or NSAIDs affecting platelet function; 8. Current treatment (last dose given within 10d before randomization) with heparin therapy or oral anticoagulation; 9. Gastrointestinal bleed or major surgery within 3 m; 10. Planned or likely revascularization (any angioplasty or vascular surgery) within the next 3m (if clinically indicated, vascular imaging should be performed before randomization whenever possible); 11. Scheduled for surgery or interventional treatment requiring study drug cessation; 12. TIA or minor stroke induced by angiography or surgery; 13. Severe noncardiovascular comorbidity with life expectancy <3 m; 14. Women of childbearing age not practicing reliable contraception who do not have a documented negative pregnancy test result; 15. Currently receiving an investigational drug or device.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| new stroke event (ischemic or hemorrhagic) at 90 days; | — |
Secondary
| Measure | Time frame |
|---|---|
| combination of any stroke, myocardial infarction, and vascular death; | — |
Countries
China
Contacts
Public ContactXiaodong Chen
Department of Neurology, Shuyang People's Hospital
Outcome results
None listed