Long-Term Sequential Dual Antiplatelet Therapy Based on Cilostazol in Symptomatic Intracranial Arterial Stenosis
Key facts
- Who runs it
- Second Affiliated Hospital of Soochow University
- Where
- China1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Recruiting
- Phase
- Phase 4
- People taking part
- 480 people, planned
- Started
- 21 Mar 2026
- Expected to end
- 30 Jun 2029
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Cilostazol
- Aspirin
- Clopidogrel
- Ticagrelor
- Record updated
- 12 November 2026
Who can take part
- Age
- 18 years to 80 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 21 criteriaShow less
Who can take part
- Age: 18-80 years old
- Acute mild non-cardioembolic stroke
- Ischemic stroke or transient ischemic attack (TIA) occurring 2 to 4 weeks prior to enrollment
- NIHSS score ≤15 at enrollment and pre-stroke mRS score ≤2
- Ischemic stroke or TIA attributable to the territory of the qualifying intracranial artery
- Symptomatic 70%-99% intracranial atherosclerotic stenosis confirmed by DSA, CTA, or MRA
- Completion of 3 months of standard dual antiplatelet therapy (DAPT)
- Medication adherence ≥80% during the 3 months of standard DAPT
- High risk for recurrent stroke (defined by at least one prespecified high-risk feature) at the second screening after 3 months of standard DAPT
- No intracranial endovascular or surgical revascularization within the preceding 3 months
- No newly developed contraindications to cilostazol-based DAPT or single antiplatelet therapy
- Signed informed consent by the patient or legally authorized representative
Who cannot take part
- Current or previous severe heart failure
- Severe bleeding event within the previous 6 months, including spontaneous intracranial hemorrhage, major gastrointestinal bleeding, or other bleeding requiring blood transfusion
- 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
- Stroke or TIA caused by nonatherosclerotic disease, including moyamoya disease, vasculitis, arterial dissection, or other definite nonatherosclerotic causes
- Known allergy or serious adverse reaction to cilostazol, aspirin, clopidogrel, ticagrelor, or other antiplatelet agents
- Significant bleeding tendency or coagulation abnormality
- Medical condition requiring long-term oral anticoagulation
- Active malignancy or other serious illness with a life expectancy of less than 1 year
- Severe cognitive impairment or psychiatric illness that would prevent adherence to study treatment or long-term follow-up
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Cilostazol-Based Dual Antiplatelet TherapyTreatment being tested
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.
Treatment: Cilostazol, Aspirin, Clopidogrel, and Ticagrelor
- Single Antiplatelet TherapyExisting treatment, for comparison
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.
Treatment: Aspirin, Clopidogrel, and Ticagrelor
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- The Secondary Preventive Effect of Long-term Sequential Dual Antiplatelet Therapy Based on Cilostazol in Cerebral Infarction Patients With Symptomatic Moderate to Severe Intracranial Arterial Stenosis: A Single-Center, Randomized, Open-Label, Blinded-Endpoint Clinical Trial (SPDACSIS-RCT)
- Fit questions
- Built from NCT07932639, who can take part
- Record updated
- 12 November 2026