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Starting soon Phase 3

Cilostazol for Prevention of Recurrent Stroke Trial

NCT07174414 · tracked via the Priya Life Science Israel tracker
Phase
Phase 3
Started
2026-10
Last updated
2026-10-26

Condition(s) studied

Stroke RecurrenceMyocardial InfarctionVascular DeathIschemic StrokeTIA (Transient Ischemic Attack)Stroke (CVA) or Transient Ischemic AttackRecurrent Stroke

Investigational drug(s) / intervention(s)

Cilostazol 100 mg Tablets →Placebo

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

Sex
ALL
Min age
40 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. ≥40 years 2. Ischemic stroke or high-risk TIA (ABCD2 score ≥6) 3. Can be randomized within 180 days after ischemic stroke or high-risk TIA 4. Treatment with single or dual antithrombotic therapy with aspirin, clopidogrel and/or ticagrelor per international and/or national guidelines 5. Two or more of the following risk factors: age 65 years or older, hypertension, diabetes mellitus, history of ischemic stroke other than the qualifying event for this trial, currently smoking, peripheral arterial disease, coronary artery disease including prior MI, aortic atherosclerotic plaque ≥4 mm, ≥50% stenosis or occlusion of a major intracranial artery (ICA, M1, M2, A1, P1, vertebral, or basilar) or extracranial artery (ICA or vertebral) 6. In the opinion of the site investigator, patient is medically stable, capable of participating in the trial, and willing and able to attend follow-up 7. Able to receive study drug by mail and able to begin taking study drug promptly after receipt 8. Provision of signed and dated informed consent form by patient or legally authorized representative Exclusion Criteria: 1. Atrial fibrillation, mechanical heart valve, or left ventricular assist device 2. Use of prohibited medication (as specified in the MOP) 3. Modified Rankin Scale 5 4. Planned cardiac surgery, percutaneous coronary intervention, carotid endarterectomy or stenting (patients are eligible post-procedure) 5. History of symptomatic non-traumatic intracerebral hemorrhage within last 2 years 6. Known thrombocytopenia (platelet count ≤100,000 per microliter (µL)) 7. Severe liver dysfunction (active hepatitis or hepatic insufficiency with Child-Pugh score B or C) 8. Pregnant, breast-feeding, or of child-bearing potential but not on birth control 9. Confirmed diagnosis of heart failure with current or prior symptoms or signs (e.g. paroxysmal nocturnal dyspnea, reduced exercise tolerance, ankle swelling, elevated jugular venous pressure) 10. Hypersensitivity to cilostazol or any component of the formulation (e.g. anaphylaxis, angioedema) 11. Currently enrolled in an investigational intervention study 12. Life expectancy less than 6 months 13. Participant does not allow contacting of their surrogate (e.g. family member or friend) or health care practitioner to obtain health information should participant become unwilling or unable to follow the study schedule. 14. Participants who are incarcerated, including prisoners or participants compulsorily detained for treatment of psychiatric disease.

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)

FacilityCityRegionStatus
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.

Official registry record

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