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Edoxaban for TIA and Acute Minor Stroke

NCT02221102 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 3700

Last updated 2014-08-20

No results posted yet for this study

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

DRUG

Aspirin

non-steroidal anti-inflammatory drugs

DRUG

edoxaban

orally active direct factor Xa inhibitor

DRUG

placebo

Sponsors & Collaborators

  • Xijing Hospital

    lead OTHER

Principal Investigators

  • Gang Zhao, M.D. · Xijing hostipal

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2015-06-30
Completion
2016-06-30

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02221102 on ClinicalTrials.gov