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Recruiting NCT06757764

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

Phase IV Interventional Cerebral Infarction Stenosis Artery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Aspirin, Clopidogrel, Cilostazol, Placebo.
Who it may be relevant to
Registry conditions: Cerebral Infarction, Stenosis Artery. Basic parameters: from 20 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

The Effect and Safety of Therapy Adding Cilostazol in Acute Ischemic Stroke Due to Large Artery Atherosclerosis: CHANGE Trial

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.

Interventions

  • 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)

Primary outcome measures

  • Proportion of occurrence of composite endpoint [Time frame: during admission (within 14 days) and within 180 days after stroke]
Secondary outcome measures (11)
  • Proportion of participants with good functional outcome (mRS(modified Rankin Scale) 0-2) [Time frame: at 180 days]
  • mRS score collected at 180 days [Time frame: at 180 days]
  • Proportion of participants with Neurologic Deterioration(ND) during admission [Time frame: during admission(within 14days)]
  • Proportion of participants with good functional outcome (mRS 0-2) [Time frame: at 90 days]
  • Proportion of participants with ischemic stroke recurrence [Time frame: at 90 days]
  • Proportion of participants with ischemic stroke recurrence [Time frame: at 180 days]
  • Proportion of participants with MI(Myocardial Infarction), ischemic stroke recurrence, haemorrhagic stroke and vascular death [Time frame: within 180 days]
  • Proportion of participants with haemorrhagic stroke [Time frame: within 180 days]
  • Proportion of participants with myocardial infarction [Time frame: within 180 days]
  • Proportion of participants with vascular death [Time frame: within 180 days]
  • mRS score collected at 90 days [Time frame: at 90 days]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • Large infarction unable to start antiplatelet treatment
  • Combined with acute intracranial haemorrhage
  • With initial haemorrhagic transformation
  • Previous mRS higher than 2
  • Indicated for anticoagulation
  • Contraindication for aspirin, clopidogrel or cilostazol
  • Requirement of long term NSAID
  • Pre-planned for surgery
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

South Korea · 24 centers
  • Asan Medical Center — Seoul
  • Pusan National University Hospital — Busan
  • Chungbuk National University Hospital — Cheongju-si
  • Kyungpook National University Chilgok Hospital — Daegu
  • Chungnam National University Hospital — Daejeon
  • Eulji University Hospital — Daejeon
  • Chonnam National University Hospital — Gwangju
  • Seoul National University Bundang Hospital — Gyeonggi-do
  • … and 16 more centers

Identifiers

NCT: NCT06757764 · CHANGE

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗