Trials / Recruiting
RecruitingNCT06757764
The Effect and Safety of Combined Anti-platelet Treatment in Acute Ischemic Stroke Due to Large Artery Atherosclerosis
The Effect and Safety of Therapy Adding Cilostazol in Acute Ischemic Stroke Due to Large Artery Atherosclerosis: CHANGE Trial
- Status
- Recruiting
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 2,340 (estimated)
- Sponsor
- Asan Medical Center · Academic / Other
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
Summary
Currently, aspirin plus clopidogrel is considered as a standard acute treatment of ischemic stroke, based on results of CHANCE and POINT trial. However, still a considerable portion of patients showed early stroke recurrence, especially in those with stroke due to large artery atherosclerosis. Cilostazol may have benefit in reducing early stroke recurrence of neurologic deterioriation. The post-hoc analysis of CSPS.com showed that use of cilostazol after 15 days of stroke was effective for preventing subsequent stroke. The effect of adding cilostazol was more effective in those with large artery atherosclerosis and those receiving clopidogrel than aspirin.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Aspirin | Aspirin 100mg qd (21days) * In case of stenting, aspirin will be added to cilostazol and clopidogrel until 90 days after stenting. * Route: per oral. IMP can be taken with or without food. * Frequency: once daily (qd) |
| DRUG | Clopidogrel | Clopidogrel 75mg qd (180days) * Route: per oral. IMP can be taken with or without food. * Frequency: once daily (qd) |
| DRUG | Cilostazol | Cilostazol SR 100mg x 2cap (180days) * Route: per oral. IMP can be taken with or without food. * Frequency: once daily (qd) |
| DRUG | Placebo | Placebo x 2cap (180days) * Route: per oral. IMP can be taken with or without food. * Frequency: once daily (qd) |
Timeline
- Start date
- 2025-07-10
- Primary completion
- 2028-03-31
- Completion
- 2028-03-31
- First posted
- 2025-01-03
- Last updated
- 2026-03-27
Locations
24 sites across 1 country: South Korea
Source: ClinicalTrials.gov record NCT06757764. Inclusion in this directory is not an endorsement.