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NCT Number: NCT06757764

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

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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Key information

Conditions

Cerebral Infarction Brain Diseases Brain Infarction Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Infarction Ischemia Necrosis Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stenosis Artery Stroke Vascular Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Asan Medical Center, Seoul, Songpa-gu, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Aspirin

Drug

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)

clopidogrel

Drug

Clopidogrel 75mg qd (180days)

  • Route: per oral. IMP can be taken with or without food.
  • Frequency: once daily (qd)

Cilostazol

Drug

Cilostazol SR 100mg x 2cap (180days)

  • Route: per oral. IMP can be taken with or without food.
  • Frequency: once daily (qd)

Placebo

Drug

Placebo x 2cap (180days)

  • Route: per oral. IMP can be taken with or without food.
  • Frequency: once daily (qd)

Primary outcomes

  1. Proportion of occurrence of composite endpoint

    Time frame: during admission (within 14 days) and within 180 days after stroke

    *Composite endpoint: Neurologic deterioration† during admission (within 14 days) or recurrence of ischemic stroke‡ within 180 days after stroke

    †Neurologic deterioration: Increment of 2 or more in total NIHSS(National Institutes of Health Stroke Scale) score or one or more in the motor NIHSS score.

    ‡Recurrence of ischemic stroke: A newly developed neurological deficit corresponding to a new ischemic lesion confirmed by neuro-imaging.

Secondary outcomes

  1. Proportion of participants with good functional outcome (mRS(modified Rankin Scale) 0-2)

    Time frame: at 180 days

  2. mRS score collected at 180 days

    Time frame: at 180 days

  3. Proportion of participants with Neurologic Deterioration(ND) during admission

    Time frame: during admission(within 14days)

  4. Proportion of participants with good functional outcome (mRS 0-2)

    Time frame: at 90 days

  5. Proportion of participants with ischemic stroke recurrence

    Time frame: at 90 days

  6. Proportion of participants with ischemic stroke recurrence

    Time frame: at 180 days

  7. Proportion of participants with MI(Myocardial Infarction), ischemic stroke recurrence, haemorrhagic stroke and vascular death

    Time frame: within 180 days

  8. Proportion of participants with haemorrhagic stroke

    Time frame: within 180 days

  9. Proportion of participants with myocardial infarction

    Time frame: within 180 days

  10. Proportion of participants with vascular death

    Time frame: within 180 days

  11. mRS score collected at 90 days

    Time frame: at 90 days

Other outcomes

  1. Preplanned subgroup analysis

    Time frame: during admission (within 14 days), within 180days

    For the primary endpoint, analyses will be performed in the following subgroups:

    Proportion of occurrence of composite endpoint* in patients with

    • Intracranial atherosclerosis
    • Extracranial atherosclerosis
    • Stent insertion
    • CYP2C19 poor metabolizers
    • Composite endpoint: Neurologic deterioration during admission (within 14 days) or recurrence of ischemic stroke within 180 days after stroke

  2. Time to recurrence of ischemic stroke

    Time frame: within 180days

Study contacts

Contact information is provided by the study sponsor or research team.

Bum Joon Kim, Professor

CONTACT

[email protected]

+82-2- 3010-3981

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Collaborators

  • Korea Otsuka Pharmaceutical Co., Ltd.

Registry information

Official study title

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

Acronym: CHANGE

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jan 3, 2025
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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