Status:
UNKNOWN
Edoxaban for TIA and Acute Minor Stroke
Lead Sponsor:
Xijing Hospital
Conditions:
Ischemia
Stroke
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
December 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2016
Estimated Enrollment :
3700 Patients enrolled
Trial Details
Trial ID
NCT02221102
Start Date
December 1 2013
End Date
June 1 2016
Last Update
August 20 2014
Active Locations (1)
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1
Xijing Hospital
Xi'an, Shaanxi, China, 710032