drugset / Trial / NCT01923818

Treatment of Rivaroxaban Versus Aspirin for Non-disabling Cerebrovascular Events

NCT01923818

Phase 2/3 Unknown 3700 enrolled Xijing Hospital
RandomizedParallel-groupTriple-blindTreatment

Summary

Transient ischemic attack (TIA) or minor ischemic stroke has a high risk of early recurrent stroke. As the golden standard, aspirin effect modestly on acute ischemic stroke, and slightly increase the risk of intracerebral hemorrhage. Recently, rivaroxaban, a new oral anticoagulant, is proved to be as effective as traditional anticoagulants, while carrying significantly less risk of intracranial hemorrhage. The TRACE trial is a randomized, double-blind, multicenter, controlled clinical trial in China. The investigators will assess the hypothesis that a 30-days rivaroxaban regimen is superior to aspirin alone for the treatment of high-risk patients with acute nondisabling cerebrovascular event.

Timeline

Start
2013-09
Primary completion
2015-09
Completion
2016-04

Drugs

EvaluationDrugModalityDoseRoute
Comparator Aspirin Small molecule 100 mg
Subject Rivaroxaban Other / unclassified 5 mg Oral
Subject Rivaroxaban Other / unclassified 10 mg Oral