ClinicalTrials.gg
RecruitingNCT07935408SPDACSIS-COHUpdated Nov 13, 2026

Long-Term Sequential Dual Antiplatelet Therapy Based on Cilostazol in Symptomatic Intracranial Arterial Stenosis: A Real-World Cohort Study

An observational study 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 2026-11-13.

Sponsored by Second Affiliated Hospital of Soochow University · Observational

From the registry’s dates

  • Started Mar 2026; still recruiting 8 months later.
Updated Nov 13, 2026Newly registeredGo to Updates ↓

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Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
990
Ages
18 Years to 80 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 750 studies in Ischemic Stroke with a site in China — 377 open to participants now, 396 under way, 76 of them phase 3. Ischemic Stroke · China.

Planned enrollment
81st of 187
990 · median 650
Started
2026
with 121 others
Observational
187 of 750
107 open now
Primary completion
2029-03
later than 359 of 395 live
Registered
748th of 750
by date

Among the 750 studies in Ischemic Stroke with a site in China, this one is the 81st largest by planned enrollment of the 187 observational ones that give a count, is one of 122 that started in 2026, is one of 187 observational ones, reaches primary completion later than 359 of the 395 other live ones, and was the 748th registered.

Ischemic Stroke

2,619 studies on the registry are indexed under Ischemic Stroke; 976 are open to participants now.

Browse Ischemic Stroke studies →

Open to participants now

377 of the 750 studies in Ischemic Stroke with a site in China are open now. Recruiting first, the newest first:

372 more — sign in →

All 377 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

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 →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 750 studies in Ischemic Stroke with a site in China, or all of them as a file.
02

Study summary

This study aims to evaluate whether long-term dual antiplatelet therapy (DAPT) with cilostazol is associated with a lower 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.

Read the detailed description

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 real-world cohort study aims to evaluate the effectiveness and safety of long-term cilostazol-based DAPT compared with SAPT in patients with symptomatic moderate-to-severe intracranial arterial stenosis. Treatment strategies are determined according to routine clinical practice rather than assigned by the study protocol.

03

Conditions studied

  • Ischemic Stroke
  • Symptomatic Intracranial Atherosclerotic Stenosis

Browse trials for

Keywords

  • Cilostazol
  • l Secondary Prevention
  • Ischemic Stroke
  • Dual Antiplatelet Therapy
04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with symptomatic intracranial atherosclerotic stenosis who have experienced a recent ischemic stroke or transient ischemic attack and completed 3 months of standard dual antiplatelet therapy. The cohort includes both retrospectively identified historical patients and prospectively enrolled patients who receive cilostazol-based dual antiplatelet therapy or single antiplatelet therapy according to routine clinical practice.

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.

Inclusion criteria

  1. Age: 18-80 years old.
  2. Acute mild non-cardioembolic stroke.
  3. Ischemic stroke or (TIA) occurring 2 to 4 weeks prior to enrollment.
  4. NIHSS score ≤15 at enrollment and pre-stroke mRS score ≤2.
  5. Ischemic stroke or TIA attributable to the territory of the qualifying intracranial artery.
  6. Symptomatic 70%-99% intracranial atherosclerotic stenosis confirmed by DSA, CTA, or MRA.

Exclusion criteria

Exclusion Criteria:

  1. High-risk cardioembolic source requiring or potentially requiring long-term anticoagulation, including persistent or paroxysmal atrial fibrillation, mechanical heart valve or severe valvular disease, intracardiac thrombus, recent myocardial infarction with significant wall-motion abnormality, or severe cardiomyopathy.
  2. Stroke or caused by nonatherosclerotic disease, including moyamoya disease, vasculitis, arterial dissection, or other definite nonatherosclerotic causes.
  3. Known allergy or serious adverse reaction to cilostazol, aspirin, clopidogrel, ticagrelor, or other antiplatelet agents.
  4. Current or previous severe heart failure.
  5. Severe bleeding event within the previous 6 months, including spontaneous intracranial hemorrhage, major gastrointestinal bleeding, or other bleeding requiring blood transfusion.
  6. Significant bleeding tendency or coagulation abnormality.
  7. Medical condition requiring long-term oral anticoagulation.
  8. Active or other serious illness with a of less than 1 year.
  9. Severe cognitive impairment or psychiatric illness that would prevent adherence to study treatment or long-term follow-up.
Terms in these criteria, in plain language(3)

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.

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.

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.

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.

05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
990 participants (estimated)
Patient registry
No

Groups and cohorts

  • Cilostazol-Based Dual Antiplatelet Therapy

    Participants who receive cilostazol 50 mg twice daily in combination with aspirin 100 mg once daily, clopidogrel 75 mg once daily, or ticagrelor 90 mg twice daily for 12 months according to routine clinical practice.

    Drug: Cilostazol-Based Dual Antiplatelet Therapy

  • Single Antiplatelet Therapy

    Participants who receive single antiplatelet therapy with aspirin 100 mg once daily, clopidogrel 75 mg once daily, or ticagrelor 90 mg twice daily for 12 months according to routine clinical practice.

    Drug: Single Antiplatelet Therapy

Interventions

  • DrugCilostazol-Based Dual Antiplatelet Therapy

    Participants receive cilostazol 50 mg twice daily in combination with aspirin 100 mg once daily, clopidogrel 75 mg once daily, or ticagrelor 90 mg twice daily according to routine clinical practice.

  • DrugSingle Antiplatelet Therapy

    Participants receive single antiplatelet therapy with aspirin 100 mg once daily, clopidogrel 75 mg once daily, or ticagrelor 90 mg twice daily according to routine clinical practice.

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. Incidence of Any Stroke

    Occurrence of any ischemic or hemorrhagic stroke during follow-up.

    Time frame: 12 months

  2. Incidence of Hemorrhagic Stroke

    Occurrence of symptomatic intracranial hemorrhage or subarachnoid hemorrhage.

    Time frame: 12 months

  3. Incidence of Ischemic Stroke or Transient Ischemic Attack

    Occurrence of ischemic stroke or transient ischemic attack during follow-up.

    Time frame: Time Frame

  4. 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

  5. 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

Other outcomes

  1. 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

  2. Incidence of Adverse Events

    Occurrence of any adverse event during the 12-month treatment and follow-up period.

    Time frame: 12 months

  3. 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

07

Study locations

1 of 1 sites recruiting
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2026 (actual). Primary completion is estimated for Mar 2029, 36 months after the start.

Of 396 non-industry observational studies under Ischemic Stroke, half reached primary completion within 56 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 140. This study's planned 36 months is below that.

Counting every sponsor, half of 438 studies reached it within 53 months; a quarter within 24 and three quarters within 127.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 2, 2026
First posted
Nov 13, 2026
StartActual
Mar 1, 2026
Primary completionEst.
Mar 30, 2029
CompletionEst.
Jun 30, 2029
Last update
Nov 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 13, 2026
Show all 1 update
  1. Nov 13, 2026
    First appeared on the registry

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 ↗

09

Registry details

Key details

Study ID
NCT07935408
Lead sponsor
Second Affiliated Hospital of Soochow University
Responsible party
Sponsor
First posted
Nov 13, 2026
Start date
Mar 1, 2026
Primary completion
Mar 30, 2029 (estimated)
Completion
Jun 30, 2029 (estimated)
Last update
Nov 13, 2026

Study contacts

Yongjun Cao, M.D, PhD
Contact
yongjuncao@126.com
+86 512 67784789

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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