NCT02221102

Edoxaban for TIA and Acute Minor Stroke

Treatment of Edoxaban Versus Aspirin for Non-disabling Cerebrovascular Events: Rationale, Objectives, and Design

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 3,700 (estimated)
• Sponsor: Xijing Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 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, edoxaban, a new oral anticoagulant, is proved to be as effective as traditional anticoagulants, while carrying significantly less risk of intracranial hemorrhage. This trial is a randomized, double-blind, multicenter, controlled clinical trial in China. The investigators will assess the hypothesis that a 30-days edoxaban regimen is superior to aspirin alone for the treatment of high-risk patients with acute nondisabling cerebrovascular event.

Conditions

• Ischemia
• Stroke
• Cerebral Infarction

Interventions

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

Timeline

• Start date: 2013-12-01
• Primary completion: 2015-06-01
• Completion: 2016-06-01
• First posted: 2014-08-20
• Last updated: 2014-08-20

Locations

1 site across 1 country: China