To determine whether the combination of clopidogrel plus acetylsalicylic acid (ASA) is superior to clopidogrel alone in preventing ischemic events in patients with a recent TIA or ischemic stroke.
- Aspirin (stroke prevention) Drug
Intervention Desc: Antiplatelet agent; inhibits thromboxane A2
- Clopidogrel (Plavix®)Drug
Other Names: Plavix, Clodelib, Clovelen Intervention Desc: Antiplatelet agent
International, randomized, double-blind, prospective, parallel-group trial with a planned enrollment of 7600 patients.
Patients will be randomized to receive ASA 75 mg or placebo once per day. Both groups will receive clopidogrel 75 mg once per day. Patients will be treated for 18 months with follow-up visits at 1 month, 3 months, 6 months, 12 months and 18 months, in addition to regular phone calls between visits.
|Type||Measure||Time Frame||Safety Issue|
|Primary||Composite incidence of ischemic stroke, MI, vascular death, and rehospitalization for an acute ischemic event.|
|Secondary||Any death, any stroke, modified Rankin scale (MRS) assessment, life-threatening bleeding events, all bleeding events, other adverse events.|