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Could cilostazol beat aspirin at preventing strokes?

NCT ID NCT07180472

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study compares cilostazol, aspirin, and clopidogrel in 632 people who recently had a stroke due to cerebral small vessel disease. The goal is to see if cilostazol is better at preventing another stroke and slowing disease progression, with fewer bleeding risks. Participants will take one of the three drugs and be followed for outcomes like new strokes, cognitive decline, and disability.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Cilostazol
What this could lead to
If it works, this could provide a safer and more effective option to prevent recurrent strokes and slow cognitive decline in people with cerebral small vessel disease.
What could go wrong
This is a Phase 4 trial, but results may not apply to all patients. Cilostazol may not prove superior to existing drugs, and bleeding risks remain possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 632 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2025

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age between 18 and 80 years. 2. Diagnosis of small artery occlusion ischemic stroke based on the TOAST classification, with symptom onset within the past 6 months. 3. MRI findings indicating white matter hyperintensities, with Fazekas grade ≥2. 4. mRS (modified Rankin Scale) score ≤2. 5. CDR (Clinical Dementia Rating) score \<1. Exclusion Criteria: 1. Presence of other central nervous system (CNS) disorders, including CNS infections, immune-mediated or degenerative diseases, epilepsy, intracranial tumors, etc. 2. History of drug or alcohol abuse, or severe psychiatric disorders. 3. Diagnosis of malignant tumors. 4. Severe hepatic dysfunction (alanine aminotransferase \[ALT\] or aspartate aminotransferase \[AST\] \>3 times the upper limit of normal) or renal impairment (creatinine clearance \<25 mL/min). 5. Concomitant congestive heart failure. 6. Systemic hemorrhagic disorders or bleeding tendency, including platelet count ≤100,000/mm³, coagulation abnormalities, gastrointestinal ulcers, or history of non-traumatic symptomatic intracranial hemorrhage. 7. Conditions requiring long-term anticoagulation therapy, such as atrial fibrillation or deep vein thrombosis. 8. Known allergy or contraindication to cilostazol, clopidogrel, or aspirin. 9. Requirement for dual antiplatelet therapy during the study period (e.g., due to vascular stent implantation or symptomatic intracranial arterial stenosis). 10. Inability to complete scale assessments or comply with long-term follow-up. 11. Pregnancy, lactation, or planning to become pregnant. 12. Participation in another interventional clinical trial. 13. Any other condition deemed unsuitable for study participation by the investigator.

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Conditions

The condition(s) this trial relates to.

Cerebral Small Vessel Diseases ischemic stroke prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

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