Cilostazol for Prevention of Recurrent Stroke Trial

Not Applicable

Not yet recruiting

• Conditions: Stroke Recurrence; Myocardial Infarction; Vascular Death; Ischemic Stroke; TIA (Transient Ischemic Attack); Stroke (CVA) or Transient Ischemic Attack; Recurrent Stroke
• Interventions: Drug: Cilostazol 100 mg; Drug: Placebo

• Registration Number: NCT07174414
• Lead Sponsor: Stanford University

Brief Summary

The goal of this clinical trial is to learn whether adding cilostazol to aspirin or clopidogrel prevents stroke and heart attack in people who have had a stroke or mini-stroke.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-12
• Study First Submitted QC: 2025-09-12
• Last Update Submitted: 2025-09-12
• Study First Posted: 2025-09-16
• Last Update Posted: 2025-09-16
• Study Start: 2026-08-01
• Primary Completion: 2031-07
• Study Completion: 2031-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

• Diagnosis of stroke or mini-stroke (also called TIA) within the last 180 days
• Currently taking aspirin or clopidogrel (not both) to prevent another stroke

Exclusion Criteria

• Had a spontaneous brain bleed within the last 2 years.
• Moderate to severe heart failure.
• Life expectancy is less than 6 months.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cilostazol 100mg	Cilostazol 100 mg	Participants take oral cilostazol until a study endpoint occurs, they reach maximum follow up duration (4 years), the participant withdraws, or the study ends.
Placebo	Placebo	Participants take oral placebo until a study endpoint occurs, they reach maximum follow up duration (4 years), the participant withdraws, or the study ends.

Primary Outcome Measures

Name	Time	Method
Major adverse cardiovascular event (MACE)	Up to 4 years after randomization	Time to stroke (ischemic and hemorrhagic), acute myocardial infarction, or vascular death

Secondary Outcome Measures

Name	Time	Method
Ischemic stroke	Up to 4 years after randomization	Time to ischemic stroke
Major hemorrhage	Up to 4 years after randomization	Time to major hemorrhage

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Stanford, California, United States