NCT01923818

Treatment of Rivaroxaban Versus Aspirin for Non-disabling Cerebrovascular Events

Randomized,Double-blind Trial Comparing the Effects of a Rivaroxaban Regimen During the First 30 Days,Versus Aspirin for the Acute Treatment of TIA or Minor Stroke

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 3,700 (estimated)
• Sponsor: Xijing Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The TRACE study is a randomized, double-blind clinical trial with a target enrollment of 3,700 Chinese patients. Two subtypes of patients will be enrolled: I, acute disabling ischemic stroke (\<24 hours of symptoms onset); II, acute TIA (\<24 hours of symptoms onset). Patients will be randomized into 3 groups: * Receiving a 100-mg dose of aspirin and placebo rivaroxaban from day 1 to day 30 * Receiving a 5-mg dose of rivaroxaban and placebo aspirin from day 1 to day 30 * Receiving a 10-mg dose of rivaroxaban and placebo aspirin from day 1 to day 30 The primary efficacy end point is percentage of patients with new stroke (ischemic or hemorrhage) at 90 days.

Conditions

• Ischemic Stroke
• TIA

Interventions

Type	Name	Description
DRUG	rivaroxaban	orally active direct factor Xa inhibitor
DRUG	Aspirin	non-steroidal anti-inflammatory drugs
DRUG	placebo

Timeline

• Start date: 2013-09-01
• Primary completion: 2015-09-01
• Completion: 2016-04-01
• First posted: 2013-08-16
• Last updated: 2013-08-16

Locations

1 site across 1 country: China