NCT06530537 Cilostazol vs. Aspirin in Acute Non-cardioembolic Stroke With Cerebral mIcrobleeds
| NCT ID | NCT06530537 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Zhejiang Provincial People's Hospital |
| Condition | Cerebral Microbleeds |
| Study Type | INTERVENTIONAL |
| Enrollment | 848 participants |
| Start Date | 2024-07-18 |
| Primary Completion | 2031-08-30 |
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 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 848 participants in total. It began in 2024-07-18 with a primary completion date of 2031-08-30.
⚠ 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
The purpose of this clinical trial is to demonstrate that cilostazol is non-inferior to aspirin in terms of efficacy and safety for the secondary prevention of stroke in patients with acute non-cardioembolic ischemic stroke who have concurrent microbleeds. Researchers will compare the medication cilostazol with aspirin to assess its efficacy and safety in these patients. Participants will: Take the medication cilostazol or aspirin daily as part of an antiplatelet drug therapy. Have baseline data and follow-up data collected at the time of hospital admission, and then at 3 months, 6 months post-discharge, and annually thereafter up to 4 years. Have the primary endpoint set as stroke recurrence, with secondary endpoints being composite vascular events. Safety events will include moderate to severe hemorrhage and bleeding at any site.
Eligibility Criteria
Inclusion Criteria: * Acute ischemic stroke (within 1 month of onset) * Non-cardioembolic stroke * Presence of cerebral microbleeds (CMBs) confirmed by susceptibility-weighted imaging (SWI) Exclusion Criteria: * Previous diagnosis of cerebral amyloid angiopathy (CAA) according to the Boston 2.0 diagnostic criteria * History of intracerebral hemorrhage highly suspected to be caused by CAA-related lobar hemorrhage * Severe adverse reactions (such as active bleeding, severe allergies, etc.) to aspirin or cilostazol in the past, leading to non-compliance with medication * Requirement for combined anticoagulant therapy * Requirement for long-term dual antiplatelet therapy (\>1 month)
Frequently Asked Questions
Who can join the NCT06530537 clinical trial?
This trial is open to participants of all sexes, aged 35 Years or older, studying Cerebral Microbleeds. 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 NCT06530537 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 848 participants.
Is NCT06530537 currently recruiting?
Yes, NCT06530537 is actively recruiting participants. Visit ClinicalTrials.gov or contact Zhejiang Provincial People's Hospital to inquire about joining.
Where is the NCT06530537 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT06530537 clinical trial?
NCT06530537 is sponsored by Zhejiang Provincial People's Hospital. The trial plans to enroll 848 participants.