drugset / Trial / NCT01924325

Apixaban Versus Dual-antiplatelet Therapy (Clopidogrel and Aspirin) in Acute Non-disabling Cerebrovascular Events

NCT01924325

Phase 2/3 Unknown 10000 enrolled Xijing Hospital
RandomizedParallel-groupTriple-blindTreatment

Summary

Nondisabling cerebrovascular events represent the largest group of cerebrovascular disease with a high risk of recurrent stroke. A recent trial indicated that clopidogrel and aspirin treatment reduced the risk of recurrent stroke and was not associated with increased hemorrhage events, compared with aspirin monotherapy. Apixaban, a new oral anticoagulant, is proved to be as effective as traditional anticoagulants with less risk of bleeding events. To estimate whether apixaban is beneficial for acute TIA or minor stroke, a randomized, double-blind, multicenter, controlled clinical trial has been designed. The investigators will assess the hypothesis that a 21-days apixaban regimen is superior to clopidogrel and aspirin dual-therapy for the treatment of high-risk patients with acute nondisabling cerebrovascular event.

Timeline

Start
2014-01
Primary completion
2015-12
Completion
2016-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Apixaban Small molecule 2.5 mg Oral
Subject Apixaban Small molecule 5 mg Oral
Comparator Aspirin Small molecule 75 mg
Comparator Clopidogrel Small molecule 75 mg