NCT07932639 Long-Term Sequential Dual Antiplatelet Therapy Based on Cilostazol in Symptomatic Intracranial Arterial Stenosis
| NCT ID | NCT07932639 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Second Affiliated Hospital of Soochow University |
| Condition | Ischemic Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 480 participants |
| Start Date | 2026-03-21 |
| Primary Completion | 2029-02-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 480 participants in total. It began in 2026-03-21 with a primary completion date of 2029-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Age: 18-80 years old. 2. Acute mild non-cardioembolic stroke. 3. Ischemic stroke or transient ischemic attack (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. 7. Completion of 3 months of standard dual antiplatelet therapy (DAPT). 8. Medication adherence ≥80% during the 3 months of standard DAPT. 9. High risk for recurrent stroke (defined by at least one prespecified high-risk feature) at the second screening after 3 months of standard DAPT. 10. No intracranial endovascular or surgical revascularization within the preceding 3 months. 11. No newly developed contraindications to cilostazol-based DAPT or single antiplatelet therapy. 12. Signed informed consent by the patient or legally authorized representative. 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 TIA 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 malignancy or other serious illness with a life expectancy of less than 1 year. 9. Severe cognitive impairment or psychiatric illness that would prevent adherence to study treatment or long-term follow-up.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07932639 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Ischemic Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07932639 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07932639 currently recruiting?
Yes, NCT07932639 is actively recruiting participants. Contact the research team at yongjuncao@126.com for enrollment information.
Where is the NCT07932639 trial being conducted?
This trial is being conducted at Suzhou, China.
Who is sponsoring the NCT07932639 clinical trial?
NCT07932639 is sponsored by Second Affiliated Hospital of Soochow University. The trial plans to enroll 480 participants.
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