Status:
COMPLETED
Cilostazol and Aspirin in Stroke and TIA
Lead Sponsor:
Incheon St.Mary's Hospital
Conditions:
Ischemic Stroke
TIA
Eligibility:
All Genders
40+ years
Phase:
PHASE4
Brief Summary
This study is a randomized, open-labelled trial. We randomly assigned patients within 24 hours after the onset of minor ischemic stroke or high-risk TIA to combination therapy with cilostazol and aspi...
Detailed Description
This study is a randomized, open-labelled trial. We randomly assigned patients within 24 hours after the onset of minor ischemic stroke or high-risk TIA to combination therapy with cilostazol and aspi...
Eligibility Criteria
Inclusion
- Diagnosis of an acute minor ischemic stroke or TIA
- Acute minor stroke was defined by a score of 3 or less at the time of randomization on the National Institutes of Health Stroke Scale (NIHSS; scores range from 0 to 42, with higher scores indicating greater deficits)
Exclusion
- Intracerebral Hemorrhage
- Brain tumor
- Brain abscess, or other major non-ischemic brain disease;
- Isolated sensory symptoms (numbness, isolated visual changes, or isolated dizziness or vertigo) without evidence of acute infarction on baseline CT or MRI of the head
- A score of more than 2 on the modified Rankin scale, immediately before the occurrence of the index ischemic stroke or TIA, indicating moderate disability or worse at baseline
- An NIHSS score of 4 or more at randomization
- A clear indication for anticoagulation therapy (presumed cardiac source of embolus, such as atrial fibrillation or prosthetic cardiac valve) or a contraindication to clopidogrel, cilostazol or aspirin
- History of intracranial hemorrhage
- Anticipated requirement for long-term non-study antiplatelet drugs or for nonsteroidal anti-inflammatory drugs affecting platelet function
- Heparin therapy or oral anticoagulation therapy within 10 days before randomization
- Gastrointestinal bleeding or major surgery within the previous 3 months
- Planned or probable revascularization (any angioplasty or vascular surgery) within 3 months after screening (if clinically indicated, vascular imaging was to be performed before randomization, whenever possible)
- Planned surgery or interventional treatment requiring cessation of the study drug
- TIA or minor stroke caused by angiography or surgery
- Severe non- cardiovascular coexisting condition, with a life expectancy of less than 3 months
Key Trial Info
Start Date :
July 18 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 17 2022
Estimated Enrollment :
378 Patients enrolled
Trial Details
Trial ID
NCT06522113
Start Date
July 18 2019
End Date
October 17 2022
Last Update
August 6 2024
Active Locations (1)
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1
The Catholic university of korea, Incheon St. Mary's hospital
Incheon, South Korea