Combined antiplatelet treatment for acute ischemic stroke due to large artery atherosclerosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 4 randomized interventional trial enrolls adults within 72 hours of an acute ischemic stroke attributed to large artery atherosclerosis confirmed by diffusion-weighted MRI and ≥50% stenosis on MR or CT angiography. All participants receive standard aspirin plus clopidogrel and are randomized to receive either cilostazol or placebo in addition to dual antiplatelet therapy. Outcomes include early recurrent ischemic stroke, neurological deterioration, and safety endpoints such as hemorrhagic complications. The trial aims to determine whether adding cilostazol reduces early recurrence compared with placebo when combined with aspirin and clopidogrel.

Why it matters

Who can join: the full rules

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.

Where it's running

• Asan Medical Center
  Seoul, Songpa-gu, South Korea Recruiting
• Pusan National University Hospital
  Busan, South Korea Recruiting
• Chungbuk National University Hospital
  Cheongju-si, South Korea Recruiting
• Kyungpook National University Chilgok Hospital
  Daegu, South Korea Recruiting
• Chungnam National University Hospital
  Daejeon, South Korea Recruiting
• Eulji University Hospital
  Daejeon, South Korea Recruiting

Study contacts

• Study coordinator: Bum Joon Kim, Professor
• Email: bj.kim@amc.seoul.kr
• Phone: +82-2- 3010-3981

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.