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

RecruitingPhase 4Ages 20 Years - anyAllAsan Medical Center
NCT06757764 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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 angiography or CT angiography. 3. Informed consent obtained 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.
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What it tests

  • Aspirin
  • Clopidogrel
  • Cilostazol
  • Placebo
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Where

24 sites
Asan Medical Center
Seoul, South Korea
Pusan National University Hospital
Busan, South Korea
Chungbuk National University Hospital
Cheongju-si, South Korea
Kyungpook National University Chilgok Hospital
Daegu, South Korea
Chungnam National University Hospital
Daejeon, South Korea
Eulji University Hospital
Daejeon, South Korea
Chonnam National University Hospital
Gwangju, South Korea
Seoul National University Bundang Hospital
Gyeonggi-do, South Korea

…and 16 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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