Treatment of Rivaroxaban Versus Aspirin for Non-disabling Cerebrovascular Events — TRACE  

Ischemic Stroke Clinical Trial

Official title: 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 Not yet recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ischemic Stroke
• TIA

• NCT number: NCT01923818
• Study type: Interventional
• Source: Xijing Hospital
• Contact: Xuedong Liu, M.D.
• Phone: +86 029 84775055
• Email: liuxued@fmmu.edu.cn
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: September 2013
• Completion date: April 2016