Cilostazol for Prevention of Recurrent Stroke Trial
Condition(s) studied
Investigational drug(s) / intervention(s)
Cilostazol 100 mg Tablets: The standard dosing regimen is an initial 2-week period during which participants take one tablet of cilostazol (100 mg) orally once daily followed by a maintenance phase in which they take one tablet twice daily. For participants who are on certain interacting drugs or who experience adverse reactions on the standard dosing regimen, the dose is reduced to half a tablet twice daily.
Placebo: The standard dosing regimen is an initial 2-week period during which participants take one placebo tablet, which matches cilostazol 100 mg tablets, orally once daily followed by a maintenance phase in which they take one tablet twice daily. For participants who are on certain interacting drugs or who experience adverse reactions on the standard dosing regimen, the dose is reduced to half a tablet twice daily.
Study summary
The goal of this clinical study is to learn if adding a medicine called cilostazol to usual treatment can help prevent another stroke, a heart attack, or death in patients who had a stroke caused by a blocked blood vessel, or a "mini-stroke" (also called a TIA), in the past 6 months.
To determine if cilostazol is safe and effective at lowering the chance of strokes, heart attacks and deaths, the study will compare cilostazol to a placebo, a pill that looks the same as cilostazol but has no medicine in it.
Participants will:
* Be assigned by chance to take either cilostazol or a placebo, along with their usual medicine.
* Not know which one they are taking, and neither will the study team, which keeps the results fair.
* Be followed for up to 5 years to see if they have a stroke, heart attack, or major bleeding.
Eligibility
Primary outcome measure(s)
- Time to first occurrence of any component of the composite of ischemic stroke, acute myocardial infarction, or ischemic vascular death (MACE). — Up to 5 years after randomization
Major Adverse Cardiovascular Events (MACE) is a composite outcome. MACE is any one of the following: ischemic stroke, acute myocardial infarction (heart attack), or ischemic vascular death (death caused by a lack of blood flow). In this study, the measure is the time from randomization to a particpant's first MACE.
Trial sites (52)
| Facility | City | Region | Status |
|---|---|---|---|
| University of Alabama Hospital - Birmingham | Birmingham | Alabama | |
| University of South Alabama - University Hospital | Mobile | Alabama | |
| Chandler Regional Medical Center | Chandler | Arizona | |
| Kaiser Permanente Fontana Medical Center | Fontana | California | |
| UCSD Health La Jolla | La Jolla | California | |
| Kaiser Permanente Los Angeles Medical Center | Los Angeles | California | |
| Cedars-Sinai Medical Center | Los Angeles | California | |
| Casa Colina Hospital | Pomona | California | |
| Stanford University | Stanford | California | |
| Intermountain Health - St. Mary's Medical Center | Grand Junction | Colorado | |
| Yale New Haven Hospital | New Haven | Connecticut | |
| UF Health Jacksonville | Jacksonville | Florida | |
| Emory University Hospital | Atlanta | Georgia | |
| Grady Memorial Hospital | Atlanta | Georgia | |
| Memorial Hospital of Carbondale | Carbondale | Illinois | |
| University of Iowa Medical Center | Iowa City | Iowa | |
| University of Kansas Hospital | Kansas City | Kansas | |
| University of Maryland Medical Center | Baltimore | Maryland | |
| Boston Medical Center | Boston | Massachusetts | |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | |
| University of Michigan - University Hospital | Ann Arbor | Michigan | |
| Mclaren Flint | Flint | Michigan | |
| Abbott Northwestern Hospital | Minneapolis | Minnesota | |
| M Health Fairview University of Minnesota Medical Center | Minneapolis | Minnesota | |
| Regions Hospital | Saint Paul | Minnesota | |
| Barnes-Jewish Hospital | St Louis | Missouri | |
| SSM Health St. Louis University Hospital | St Louis | Missouri | |
| Kings County Hospital Center | Brooklyn | New York | |
| NYU Langone Hospital - Brooklyn | Brooklyn | New York | |
| NYP Weill Cornell Medical Center | New York | New York | |
| Duke University Hospital | Durham | North Carolina | |
| New Hanover Regional Medical Center | Wilmington | North Carolina | |
| Wake Forest Baptist Medical Center | Winston-Salem | North Carolina | |
| Cleveland Clinic Akron General | Akron | Ohio | |
| University of Cinncinati | Cincinnati | Ohio | |
| Oklahoma University Medical Center | Oklahoma City | Oklahoma | |
| Providence St. Vincent Medical Center | Portland | Oregon | |
| Oregon Health & Science University Hospital | Portland | Oregon | |
| UPMC Hamot | Erie | Pennsylvania | |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania |
+ 12 more sites — see the full list on the official registry below.
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07174414 on ClinicalTrials.gov ↗ ← All trials in Israel