NCT06522113

Cilostazol and Aspirin in Stroke and TIA

Cilostazol and Aspirin in Acute Minor Stroke and Transient Ischemic Attack

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 378 (actual)
• Sponsor: Incheon St.Mary's Hospital · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

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 aspirin (aspirin 100mg with cilostazol 200 mg for 21 days) or to clopidogrel plus aspirin (aspirin 100mg with clopidogrel 75mg for 21 days). The primary outcome was stroke (ischemic or hemorrhagic) during 90 days of follow-up in an intention-to-treat analysis. The primary safety outcome was the moderate-to-severe bleeding event according to (GUSTO) definition. The secondary outcomes were new clinical vascular event (ischemic or hemorrhagic stroke, myocardial infarction, or vascular death), analyzed as a composite outcome and also as individual outcomes. Vascular death was defined as death due to stroke (ischemic or hemorrhagic), systemic hemorrhage, myocardial infarction, congestive heart failure, pulmonary embolism, sudden death, or arrhythmia.

Conditions

• Ischemic Stroke
• TIA

Interventions

Type	Name	Description
DRUG	Cilostazol	patients were given cilostazol 100mg twice a day with aspirin
DRUG	Clopidogrel	patients were given clopidogrel 75mg with aspirin

Timeline

• Start date: 2019-07-18
• Primary completion: 2022-10-17
• Completion: 2022-10-17
• First posted: 2024-07-26
• Last updated: 2024-08-06

Locations

1 site across 1 country: South Korea