Cilostazol and Aspirin in Stroke and TIA (NCT06522113) | Clinical Trial Compass
CompletedPhase 4
Cilostazol and Aspirin in Stroke and TIA
South Korea378 participantsStarted 2019-07-18
Plain-language 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 aspirin or to clopidogrel plus aspirin. The primary outcome was stroke (ischemic or hemorrhagic) during 90 days of follow-up in an intention-to-treat analysis.
Who can participate
Age range40 Years
SexALL
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Inclusion Criteria:
* 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 Criteria:
* 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 imag…
What they're measuring
1
New stroke event for 90 days (Ischemic or hemorrhagic)
Timeframe: for 90 days
2
Moderate-to-severe bleeding event according to (GUSTO) definition