Edoxaban for TIA and Acute Minor Stroke

Air Force Military Medical University of People's Liberation Army

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Cerebral Infarction; Stroke; Ischemia

Treatments: Drug: placebo; Drug: Aspirin; Drug: edoxaban

Study type: Interventional

Funder types: Other

Identifiers

NCT02221102

Xijing-Edoxaban

Details and patient eligibility

About

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.

Enrollment: 3,700 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

3,700 participants in 3 patient groups

aspirin

Active Comparator group

Description:

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

Treatment:

Drug: placebo

Drug: Aspirin

edoxaban 30mg

Experimental group

Description:

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

Treatment:

Drug: edoxaban

Drug: placebo

edoxaban 60mg

Experimental group

Description:

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

Treatment:

Drug: edoxaban

Drug: placebo