Stroke Recurrence, Myocardial Infarction, Vascular Death, Ischemic Stroke, TIA (Transient Ischemic Attack), Stroke (CVA) or Transient Ischemic Attack, Recurrent Stroke
Conditions
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.
Interventions
Cilostazol 100 mg tablet taken orally twice daily following an initial 2-week period during which cilostazol is dosed at 100 mg tablet taken orally once daily to maximize tolerability.
DRUGPlacebo
Placebo 100 mg tablet twice taken orally daily following an initial 2-week period during which placebo is dosed at 100 mg taken orally once daily to maximize tolerability.
Sponsors
National Institute of Neurological Disorders and Stroke (NINDS)
Yale University
University of Cincinnati
Medical University of South Carolina
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Masked Statistician and Unmasked statistician.
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major adverse cardiovascular event (MACE) | Up to 4 years after randomization | Time to stroke (ischemic and hemorrhagic), acute myocardial infarction, or vascular death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ischemic stroke | Up to 4 years after randomization | Time to ischemic stroke |
| Major hemorrhage | Up to 4 years after randomization | Time to major hemorrhage |
Countries
United States
Outcome results
None listed