Edoxaban for TIA and Acute Minor Stroke

NCT ID: NCT02221102

Last Updated: 2014-08-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 3700 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2016-06-30

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.

Conditions

Ischemia; Stroke; Cerebral Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

aspirin

Receiving a 100-mg dose of aspirin and placebo edoxaban from day 1 to day 30

Group Type: ACTIVE_COMPARATOR

Aspirin

Intervention Type: DRUG

non-steroidal anti-inflammatory drugs

placebo

Intervention Type: DRUG

edoxaban 30mg

Receiving a 30-mg dose of edoxaban and placebo aspirin from day 1 to day 30

Group Type: EXPERIMENTAL

edoxaban

Intervention Type: DRUG

orally active direct factor Xa inhibitor

placebo

Intervention Type: DRUG

edoxaban 60mg

Receiving a 60-mg dose of edoxaban and placebo aspirin from day 1 to day 30

Group Type: EXPERIMENTAL

edoxaban

Intervention Type: DRUG

orally active direct factor Xa inhibitor

placebo

Intervention Type: DRUG

Interventions

Aspirin

non-steroidal anti-inflammatory drugs

Intervention Type: DRUG

edoxaban

orally active direct factor Xa inhibitor

Intervention Type: DRUG

placebo

Intervention Type: DRUG

Other Intervention Names

Acetylsalicylic acid; DU176b; LIXIANA TABLETS

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xijing Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gang Zhao, M.D.

Role: STUDY_CHAIR

Xijing hostipal

Locations

Xijing Hospital

Xi'an, Shaanxi, China

Countries

China

Central Contacts

Xuedong Liu

Role: CONTACT

liuxued@fmmu.edu.cn

+86 029 84775055

Facility Contacts

Fang Yang, M.D. Ph.D.

Role: primary

fyangx@fmmu.edu.cn

+86 029 84773214

Other Identifiers

Xijing-Edoxaban

Identifier Type: -

Identifier Source: org_study_id