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NOT YET RECRUITING
NCT07174414
PHASE3

Cilostazol for Prevention of Recurrent Stroke Trial

Sponsor: Stanford University

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

40 Years - Any

Study Type

INTERVENTIONAL

Enrollment

2000

Start Date

2026-10

Completion Date

2031-07

Last Updated

2026-10-26

Healthy Volunteers

No

Interventions

DRUG

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.

DRUG

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.

Locations (52)

University of Alabama Hospital - Birmingham

Birmingham, Alabama, United States

University of South Alabama - University Hospital

Mobile, Alabama, United States

Chandler Regional Medical Center

Chandler, Arizona, United States

Kaiser Permanente Fontana Medical Center

Fontana, California, United States

UCSD Health La Jolla

La Jolla, California, United States

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, United States

Cedars-Sinai Medical Center

Los Angeles, California, United States

Casa Colina Hospital

Pomona, California, United States

Stanford University

Stanford, California, United States

Intermountain Health - St. Mary's Medical Center

Grand Junction, Colorado, United States

Yale New Haven Hospital

New Haven, Connecticut, United States

UF Health Jacksonville

Jacksonville, Florida, United States

Emory University Hospital

Atlanta, Georgia, United States

Grady Memorial Hospital

Atlanta, Georgia, United States

Memorial Hospital of Carbondale

Carbondale, Illinois, United States

University of Iowa Medical Center

Iowa City, Iowa, United States

University of Kansas Hospital

Kansas City, Kansas, United States

University of Maryland Medical Center

Baltimore, Maryland, United States

Boston Medical Center

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

University of Michigan - University Hospital

Ann Arbor, Michigan, United States

Mclaren Flint

Flint, Michigan, United States

Abbott Northwestern Hospital

Minneapolis, Minnesota, United States

M Health Fairview University of Minnesota Medical Center

Minneapolis, Minnesota, United States

Regions Hospital

Saint Paul, Minnesota, United States

Barnes-Jewish Hospital

St Louis, Missouri, United States

SSM Health St. Louis University Hospital

St Louis, Missouri, United States

Kings County Hospital Center

Brooklyn, New York, United States

NYU Langone Hospital - Brooklyn

Brooklyn, New York, United States

NYP Weill Cornell Medical Center

New York, New York, United States

Duke University Hospital

Durham, North Carolina, United States

New Hanover Regional Medical Center

Wilmington, North Carolina, United States

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, United States

Cleveland Clinic Akron General

Akron, Ohio, United States

University of Cinncinati

Cincinnati, Ohio, United States

Oklahoma University Medical Center

Oklahoma City, Oklahoma, United States

Providence St. Vincent Medical Center

Portland, Oregon, United States

Oregon Health & Science University Hospital

Portland, Oregon, United States

UPMC Hamot

Erie, Pennsylvania, United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Temple University Hospital

Philadelphia, Pennsylvania, United States

Medical University of South Carolina University Hospital

Charleston, South Carolina, United States

Prisma Health Richland Hospital

Columbia, South Carolina, United States

Methodist University Hospital

Memphis, Tennessee, United States

University of Texas Health Science Center San Antonio

San Antonio, Texas, United States

Intermountain Medical Center

Murray, Utah, United States

University of Utah Healthcare

Salt Lake City, Utah, United States

UVA Medical Center

Charlottesville, Virginia, United States

Bon Secours St. Mary's Hospital

Richmond, Virginia, United States

Harborview Medical Center

Seattle, Washington, United States

J.W. Ruby Memorial Hospital

Morgantown, West Virginia, United States

University of Wisconsin - University Hospital

Madison, Wisconsin, United States