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The Effect and Safety of Combined Anti-platelet Treatment in Acute Ischemic Stroke Due to Large Artery Atherosclerosis

The Effect and Safety of Combined Anti-platelet Treatment in Acute Ischemic Stroke Due to Large Artery Atherosclerosis

Recruiting
20 years and older
All
Phase 4

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Overview

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.

Eligibility

Inclusion Criteria:

  1. Age of 20 years or older
  2. Acute ischemic stroke due to large artery atherosclerosis (both including Intra and extracranial atherosclerosis) which may be defined by a ischemic lesion confirmed at diffusion-weighted image and a corresponding significant stenosis (more than 50% of diameter reduction) proximal to the ischemic lesion confirmed by MR or CT angiography.
  3. Able to start IMP within 72h from stroke onset
  4. Acquisition of written informed consent prior to study entry

Exclusion Criteria:

  1. Large infarction unable to start antiplatelet treatment
  2. Combined with acute intracranial haemorrhage
  3. With initial haemorrhagic transformation
  4. Previous mRS higher than 2
  5. Indicated for anticoagulation
  6. Contraindication for aspirin, clopidogrel or cilostazol
  7. Requirement of long term NSAID
  8. Pre-planned for surgery
  9. Unable to withdraw consent
  10. Unavailable to participate based on judgement of the investigator
  11. Participants of reproductive potential (PORP)/ Participants of childbearing potential (POCBP) who do not agree to practice methods of birth control or remain fully abstinent from sexual activity with the potential for conception.

Study details
    Cerebral Infarction
    Stenosis Artery

NCT06757764

Asan Medical Center

24 July 2025

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