NCT06530537RecruitingPhase 3
Cilostazol vs. Aspirin in Acute Non-cardioembolic Stroke With Cerebral mIcrobleeds
The Efficacy and Safety of Cilostazol Compared to Aspirin in Acute Non-Cardioembolic Stroke Patients With Concurrent Cerebral Microbleeds: An Open-Label, Endpoint-Blinded, Randomized Non-Inferiority Clinical Trial
Source: ClinicalTrials.gov · Last updated 31 Jul 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 848 (estimated)
- First submitted
- 23 Jul 2024
- Start date
- 18 Jul 2024
- Primary completion date
- 30 Aug 2031
- Lead sponsor
- Zhejiang Provincial People's Hospital
- Diseases
- Stroke
- NCT number
- NCT06530537
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 848
- From 18 Jul 2024 to the primary completion date, 30 Aug 2031
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous diagnosis of cerebral amyloid angiopathy (CAA) according to the Boston 2.0 diagnostic criteria
- Requirement for combined anticoagulant therapy
- Requirement for long-term dual antiplatelet therapy (\>1 month)
Other illness
- 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
Who the study is looking for
- Acute ischemic stroke (within 1 month of onset)
- Non-cardioembolic stroke
- Presence of cerebral microbleeds (CMBs) confirmed by susceptibility-weighted imaging (SWI)
Age in the registry: 35 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Zhejiang Provincial People's Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.