Edoxaban for TIA and Acute Minor Stroke

Phase 2

• Conditions: Stroke; Cerebral Infarction; Ischemia
• Interventions: Drug: Aspirin; Drug: edoxaban; Drug: placebo

• Registration Number: NCT02221102
• Lead Sponsor: Xijing Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12
• Status Verified: 2014-08
• Study First Submitted: 2014-08-18
• Study First Submitted QC: 2014-08-18
• Last Update Submitted: 2014-08-18
• Study First Posted: 2014-08-20
• Last Update Posted: 2014-08-20
• Primary Completion: 2015-06
• Study Completion: 2016-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 3700

Inclusion Criteria

• Adult subjects (male or female ≥18 years old)
• Acute nondisabling ischemic stroke (NIHSS ≤3 at the time of randomization) that can be treated with study drug within 24 hours of symptoms onset. Symptom onset is defined by the "last see normal" principle
• TIA (neurologic deficit attributed to focal brain ischemia, with resolution of the deficit within 24 hours of symptom onset), that can be treated with investigational medication within 24 hours of symptoms onset. Symptom onset is defined by the "last see normal" principle
• Informed consent signed

Exclusion Criteria

• Diagnosis of hemorrhage or other pathology, such as vascular malformation, tumor, abscess or other major nonischemic brain disease, on baseline head CT or MRI scan
• mRS score >2 at randomization (premorbid historical assessment)
• NIHSS ≥4 at randomization
• Clear indication for anticoagulation (atrial fibrillation, mechanical cardiac valves, deep venous thrombosis, pulmonary embolism or known hypercoagulable state)
• Contraindication to investigational medications
• Thrombolysis for ischemic stroke within preceding 7 days
• History of intracranial hemorrhage
• Current treatment (last dose given within 10 days before randomization) with heparin therapy or oral anticoagulation
• Gastrointestinal bleed or major surgery within 3 months
• Planned or likely revascularization (any angioplasty or vascular surgery) within the next 3 months
• TIA or minor stroke induced by angiography or surgery
• Severe noncardiovascular comorbidity with life expectancy <3 months
• Women of childbearing age not practicing reliable contraception who do not have a documented negative pregnancy test result
• Severe renal failure, defined as Glomerular Filtration Rate (GFR) <30 ml/min -Severe hepatic insufficiency (Child-Pugh score B to C)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
edoxaban 60mg	placebo	Receiving a 60-mg dose of edoxaban and placebo aspirin from day 1 to day 30
aspirin	placebo	Receiving a 100-mg dose of aspirin and placebo edoxaban from day 1 to day 30
edoxaban 30mg	placebo	Receiving a 30-mg dose of edoxaban and placebo aspirin from day 1 to day 30
aspirin	Aspirin	Receiving a 100-mg dose of aspirin and placebo edoxaban from day 1 to day 30
edoxaban 30mg	edoxaban	Receiving a 30-mg dose of edoxaban and placebo aspirin from day 1 to day 30
edoxaban 60mg	edoxaban	Receiving a 60-mg dose of edoxaban and placebo aspirin from day 1 to day 30

Primary Outcome Measures

Name	Time	Method
percentage of patients with new stroke (ischemic or hemorrhage)	90 days

Secondary Outcome Measures

Name	Time	Method
Percentage of patients with new clinical vascular events (ischemic stroke/hemorrhagic stroke/TIA/myocardial infarction/vascular death)	30 days
moderate to severe bleeding events	90 days
Adverse events/severe adverse events reported by the investigators	90 days
mRS score changes (continuous) and dichotomized at percentage with score 0 to 2 versus 3 to 6	30 days and 90 days
Changes in NIHSS scores	90 days
Total mortality	90 days

Trial Locations

Locations (1)

Xijing Hospital; 🇨🇳 Xi'an, Shaanxi, China