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NCT06757764RecruitingPhase 4

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

Source: ClinicalTrials.gov · Last updated 27 Mar 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
2340 (estimated)
First submitted
26 Dec 2024
Start date
10 Jul 2025
Primary completion date
31 Mar 2028
Lead sponsor
Asan Medical Center
Diseases
Stroke
NCT number
NCT06757764

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 2340
  • From 10 Jul 2025 to the primary completion date, 31 Mar 2028
  • 24 sites 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 mRS higher than 2
  • Pre-planned for surgery

Other illness

  • Combined with acute intracranial haemorrhage

Other

  • Large infarction unable to start antiplatelet treatment
  • With initial haemorrhagic transformation
  • Indicated for anticoagulation
  • Contraindication for aspirin, clopidogrel or cilostazol
  • Requirement of long term NSAID
  • Unable to withdraw consent
  • Unavailable to participate based on judgement of the investigator
  • 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.

Who the study is looking for

  • Age of 20 years or older
  • 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.
  • Informed consent obtained within 72h from stroke onset
  • Acquisition of written informed consent prior to study entry

Age in the registry: 20 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (24)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Pusan National University Hospital
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BusanSouth KoreaRecruiting
Chungbuk National University Hospital
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Cheongju-siSouth KoreaRecruiting
Kyungpook National University Chilgok Hospital
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DaeguSouth KoreaRecruiting
Chungnam National University Hospital
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DaejeonSouth KoreaRecruiting
Eulji University Hospital
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DaejeonSouth KoreaRecruiting
Chonnam National University Hospital
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GwangjuSouth KoreaRecruiting
Seoul National University Bundang Hospital
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Gyeonggi-doSouth KoreaRecruiting
Korea University Ansan Hospital
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Gyeonggi-doSouth KoreaRecruiting
Hanyang University Guri Hospital
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Gyeonggi-doSouth KoreaRecruiting
Hallym University Medical Center
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Gyeonggi-doSouth KoreaRecruiting
Gachon University Gil Medical Center
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IncheonSouth KoreaRecruiting
Inha University Hospital
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IncheonSouth KoreaRecruiting
Jeju National University Hospital
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Jeju CitySouth KoreaRecruiting
jeonbuk National University Hospital
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JeonjuSouth KoreaRecruiting
Yonsei University Health System - Gangnam Severance Hospital
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SeoulSouth KoreaNot yet recruiting
Kyung Hee University Hospital
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SeoulSouth KoreaRecruiting
The Catholic University of Korea, Seoul ST. Mary's Hospital
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SeoulSouth KoreaRecruiting
Asan Medical Center
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SeoulSouth KoreaRecruiting
Korea University Guro Hospital
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SeoulSouth KoreaRecruiting
Ewha Womans University Seoul Hospital
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SeoulSouth KoreaRecruiting
Samsung Medical Center
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SeoulSouth KoreaRecruiting
Hanyang University Seoul Hospital
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SeoulSouth KoreaRecruiting
Kyung Hee University Hospital at Gangdong
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SeoulSouth KoreaRecruiting
Pusan National University Yangsan Hospital
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YangsanSouth KoreaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.