To evaluate the effect of antiphospholipid antibodies (aPL) positivity on recurrent stroke or thrombotic events.
- Aspirin (stroke prevention) Drug
Intervention Desc: Antiplatelet agent; inhibits thromboxane A2
- Warfarin (Coumadin®)Drug
Other Names: Coumadin; Acenocoumarol Intervention Desc: Anticoagulant (Vitamin K antagonist)
Study uses patients enrolled in WARSS, a randomized and double-blind secondary stroke and death prevention trial comparing aspirin and warfarin in two treatment arms. Antiphospholipid antibody status at baseline on all WARSS enrolled subjects. aPL status will also be documented yearly and at the time of a recurrent thrombo-occlusive event for all aPL(+) patients and one matched aPL(-) patient for each aPL(+) patient to ensure blinding of aPL status at each of the WARSS clinical centers.
Blood samples were drawn from patients prior to their randomization in the WARSS trial. Samples were analyzed for aPL status by an independent laboratory.
|Type||Measure||Time Frame||Safety Issue|
|Primary||Two-year rate of the composite end point of death from any cause, ischemic stroke, transient ischemic attack, myocardial infarction, deep vein thrombosis, pulmonary embolism, and other systemic thrombo-occlusive events.|