A Phase 4 interventional study of Cilostazol and Aspirin in Ischemic Stroke and Symptomatic Intracranial Atherosclerotic Stenosis, sponsored by Second Affiliated Hospital of Soochow University. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by Second Affiliated Hospital of Soochow University · Phase 4, Interventional, and Prevention
Among 18 studies testing cilostazol in Ischemic Stroke — 9 open to participants now, 9 under way, 7 of them phase 3. Cilostazol · Ischemic Stroke.
Among the 18 studies testing cilostazol in Ischemic Stroke, this one is the 15th largest by planned enrollment, is one of 2 that started in 2026, is one of 7 in phase 4, and was the 18th registered.
2,617 studies on the registry are indexed under Ischemic Stroke; 976 are open to participants now.
Browse Ischemic Stroke studies →9 of the 18 studies testing cilostazol in Ischemic Stroke are open now, in 3 countries. Recruiting first, the newest first:
Kafrelsheikh University · Sites in Egypt
Ages 18–75
Kafrelsheikh University · Sites in Egypt
Ages 18–75
Kafrelsheikh University · Sites in Egypt
Ages 18–75
Kafrelsheikh University · Sites in Egypt
Ages 18–75
Kafrelsheikh University · Sites in Egypt
Ages 18–75
By country, each count listing its studies:
Cilostazol: first FDA approval 1999 (PLETAL). What it is approved for, and how studies give it, is on its page →
Of the 661 Ischemic Stroke studies recruiting now, 396 (60%) set no upper age limit and 62 (9%) stop at 75 or younger; 26 take children under 18; 42 take healthy volunteers.
This study: 18 Years to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
18 studies; the count open now beside each. This study's row is marked.
First in 2009; this study’s year is marked. 2 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 480 is above the median of 120 across 1,780 interventional studies indexed under Ischemic Stroke.
Median enrollment 848 across the 18 interventional studies. Of the 6 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
None of the 18 has an industry lead sponsor. The 9 most frequent:
Second Affiliated Hospital of Soochow University is the lead sponsor of 61 studies on the registry; 32 are open to participants now.
Second Affiliated Hospital of Soochow University has 3 studies filed under Ischemic Stroke — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 18 studies testing cilostazol in Ischemic Stroke, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This study aims to evaluate whether long-term dual antiplatelet therapy (DAPT) with cilostazol reduces the risk of recurrent symptomatic ischemic stroke or all-cause mortality compared with single antiplatelet therapy (SAPT) in patients with symptomatic moderate-to-severe intracranial arterial stenosis, following the completion of standard DAPT.
Patients with symptomatic intracranial arterial stenosis remain at high risk of recurrent stroke despite standard medical treatment. Although short-term DAPT is recommended, the optimal long-term antiplatelet strategy following standard treatment remains uncertain. Cilostazol-based DAPT may provide additional protection against recurrent ischemic events with an acceptable bleeding risk. Therefore, this study aims to evaluate whether long-term cilostazol-based DAPT reduces the risk of recurrent symptomatic ischemic stroke or all-cause mortality compared to SAPT in patients with symptomatic moderate-to-severe intracranial arterial stenosis.
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.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
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.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
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 will receive cilostazol 50 mg twice daily in combination with one antiplatelet agent: aspirin 100 mg once daily, clopidogrel 75 mg once daily, or ticagrelor 90 mg twice daily, for 12 months.
Drug: Cilostazol · Drug: Aspirin · Drug: Clopidogrel · Drug: Ticagrelor
Participants will receive single antiplatelet therapy with aspirin 100 mg once daily, clopidogrel 75 mg once daily, or ticagrelor 90 mg twice daily, for 12 months.
Drug: Aspirin · Drug: Clopidogrel · Drug: Ticagrelor
Cilostazol 50 mg twice daily for 12 months. Cilostazol is administered in the experimental arm in combination with one antiplatelet agent: aspirin, clopidogrel, or ticagrelor.
Aspirin 100 mg once daily for 12 months. Aspirin may be administered in combination with cilostazol in the experimental arm or as single antiplatelet therapy in the active comparator arm.
Clopidogrel 75 mg once daily for 12 months. Clopidogrel may be administered in combination with cilostazol in the experimental arm or as single antiplatelet therapy in the active comparator arm.
Ticagrelor 90 mg twice daily for 12 months. Ticagrelor may be administered in combination with cilostazol in the experimental arm or as single antiplatelet therapy in the active comparator arm.
Time to First Recurrent Symptomatic Ischemic Stroke or All-Cause Death
Time from Day 90 randomization to the first occurrence of recurrent symptomatic ischemic stroke or death from any cause.
Time frame: From randomization through 12 months
Incidence of Any Stroke
Occurrence of any ischemic or hemorrhagic stroke during follow-up.
Time frame: 12 months
Incidence of Hemorrhagic Stroke
Occurrence of symptomatic intracranial hemorrhage or subarachnoid hemorrhage.
Time frame: 12 months
Incidence of Ischemic Stroke or Transient Ischemic Attack
Occurrence of ischemic stroke or transient ischemic attack during follow-up.
Time frame: Time Frame
Modified Rankin Scale Score
Functional outcome assessed using the Modified Rankin Scale (mRS), ranging from 0 to 6. A score of 0 indicates no symptoms, whereas a score of 6 indicates death. Higher scores represent greater disability and worse functional outcomes.(0 = no symptoms; 1 = no significant disability despite symptoms; 2 = slight disability, unable to perform all previous activities but able to manage personal affairs without assistance; 3 = moderate disability, requiring some help but able to walk without assistance; 4 = moderately severe disability, unable to walk without assistance and unable to attend to bodily needs without assistance; 5 = severe disability, bedridden, incontinent, and requiring constant nursing care and attention; and 6 = death.)
Time frame: 12 months
Incidence of All Vascular Events
Composite vascular events including stroke, myocardial infarction, and other vascular events such as aortic dissection, aortic rupture, pulmonary embolism, hospitalization for heart failure, angina or peripheral artery disease, and coronary, aortic, cervicocephalic, or peripheral arterial revascularization.
Time frame: 12 months
Major Bleeding
Number and proportion of participants who experience bleeding classified as Bleeding Academic Research Consortium (BARC) grade 3 or higher during follow-up.
Time frame: 12 months
Incidence of Adverse Events
Occurrence of any adverse event during the 12-month treatment and follow-up period.
Time frame: 12 months
Incidence of Cilostazol-Related Adverse Events Leading to Treatment Discontinuation
Number and proportion of participants in the cilostazol-based dual antiplatelet therapy group who discontinue cilostazol because of cilostazol-related adverse events, including headache, diarrhea, abnormal stools, palpitations, tachycardia, dizziness, or other adverse reactions considered related to cilostazol.
Time frame: 12 months
Plan to share: No
No publications or documents are linked to this record.
Started Mar 2026 (actual). Primary completion is estimated for Feb 2029, 35 months after the start.
Of 76 non-industry phase 4 interventional studies under Ischemic Stroke, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 42. This study's planned 35 months is above that.
Counting every sponsor, half of 85 studies reached it within 31 months; a quarter within 24 and three quarters within 41.
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 ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Studies of the drug tested here: Cilostazol
Second Affiliated Hospital of Soochow University