A Phase 3 interventional study of Cilostazol 100 mg Tablets and Placebo in Stroke Recurrence, Myocardial Infarction and Vascular Death, sponsored by Stanford University. Not yet recruiting at 52 sites in United States. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by Stanford University · Phase 3, Interventional, and Prevention
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:
2,270 studies on the registry are indexed under Myocardial Infarction; 371 are open to participants now.
This study's planned enrollment of 2,000 is above the median of 150 across 1,314 interventional studies indexed under Myocardial Infarction.
Browse Myocardial Infarction studies →Stanford University is the lead sponsor of 2,168 studies on the registry; 431 are open to participants now.
Of its 267 completed or terminated interventional studies of FDA-regulated products, 207 (78%) have results posted.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Oct 15, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants take oral cilostazol until a study endpoint occurs, they reach maximum follow up duration (5 years), the participant withdraws, or the study ends.
Drug: Cilostazol 100 mg Tablets
Participants take oral placebo until a study endpoint occurs, they reach maximum follow up duration (5 years), the participant withdraws, or the study ends.
Drug: Placebo
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.
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.
Time to first occurrence of any component of the composite of ischemic stroke, acute myocardial infarction, or ischemic vascular death (MACE).
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.
Time frame: Up to 5 years after randomization
Time to first occurrence of ischemic stroke
Ischemic stroke is a stroke caused by a blocked blood vessel in the brain. The measure is the time from randomization to the first ischemic stroke
Time frame: Up to 5 years after randomization
Time to first occurrence of major hemorrhage
Major hemorrhage is defined as the composite of 'major intracranial hemorrhage' and 'major extracranial hemorrhage', based on the International Society on Thrombosis and Haemostasis (ISTH) criteria. The measure is the time from randomization to the first major hemorrhage.
Time frame: Up to 5 years after randomization
Plan to share: No
Start is estimated for Oct 2026; primary completion for Jul 2031, 57 months later.
Of 33 non-industry phase 3 interventional studies under Myocardial Infarction, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 73. This study's planned 57 months is above that.
Counting every sponsor, half of 57 studies reached it within 43 months; a quarter within 30 and three quarters within 77.
Start moved once since we started tracking on Sep 25, 2026: Aug 2026 → Oct 2026, on Oct 15, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Cilostazol