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

NCT ID: NCT06757764

Last Updated: 2025-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

2340 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-10

Study Completion Date

2028-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Stenosis Artery Cerebral Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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CA group

Aspirin 100mg qd (21days), clopidogrel 75mg qd (180days), Cilostazol SR 100mg x 2cap (180days). In case of stenting, aspirin will be added to cilostazol and clopidogrel until 90 days after stenting.

Group Type EXPERIMENTAL

Aspirin

Intervention Type 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

Intervention Type DRUG

Clopidogrel 75mg qd (180days)

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

Cilostazol

Intervention Type DRUG

Cilostazol SR 100mg x 2cap (180days)

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

PA group

Aspirin 100mg (21days), clopidogrel 75mg qd (180days), Placebo x 2cap (180days). In case of stenting, aspirin will be added to placebo and clopidogrel until 90 days after stenting.

Group Type PLACEBO_COMPARATOR

Aspirin

Intervention Type 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

Intervention Type DRUG

Clopidogrel 75mg qd (180days)

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

Placebo

Intervention Type DRUG

Placebo x 2cap (180days)

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

Interventions

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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)

Intervention Type DRUG

Clopidogrel

Clopidogrel 75mg qd (180days)

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

Intervention Type DRUG

Cilostazol

Cilostazol SR 100mg x 2cap (180days)

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

Intervention Type DRUG

Placebo

Placebo x 2cap (180days)

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

Intervention Type DRUG

Eligibility Criteria

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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 or CT angiography.
3. Able to start IMP 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.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Korea Otsuka Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role collaborator

Asan Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Bum Joon Kim

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Asan Medical Center

Seoul, Songpa-gu, South Korea

Site Status RECRUITING

Pusan National University Hospital

Busan, , South Korea

Site Status RECRUITING

Chungbuk National University Hospital

Cheongju-si, , South Korea

Site Status RECRUITING

Kyungpook National University Chilgok Hospital

Daegu, , South Korea

Site Status RECRUITING

Chungnam National University Hospital

Daejeon, , South Korea

Site Status RECRUITING

Eulji University Hospital

Daejeon, , South Korea

Site Status RECRUITING

Chonnam National University Hospital

Gwangju, , South Korea

Site Status RECRUITING

Seoul National University Bundang Hospital

Gyeonggi-do, , South Korea

Site Status RECRUITING

Hallym University Medical Center

Gyeonggi-do, , South Korea

Site Status RECRUITING

Hanyang University Guri Hospital

Gyeonggi-do, , South Korea

Site Status RECRUITING

Korea University Ansan Hospital

Gyeonggi-do, , South Korea

Site Status RECRUITING

Gachon University Gil Medical Center

Incheon, , South Korea

Site Status RECRUITING

Inha University Hospital

Incheon, , South Korea

Site Status RECRUITING

Jeju National University Hospital

Jeju City, , South Korea

Site Status RECRUITING

Jeonbuk National University Hospital

Jeonju, , South Korea

Site Status RECRUITING

Ewha Womans University Seoul Hospital

Seoul, , South Korea

Site Status RECRUITING

Hanyang University Seoul Hospital

Seoul, , South Korea

Site Status RECRUITING

Korea University Guro Hospital

Seoul, , South Korea

Site Status RECRUITING

Kyung Hee University Hospital at Gangdong

Seoul, , South Korea

Site Status RECRUITING

Kyung Hee University Hospital

Seoul, , South Korea

Site Status RECRUITING

Samsung Medical Center

Seoul, , South Korea

Site Status RECRUITING

The Catholic University of Korea, Seoul St. Mary's Hospital

Seoul, , South Korea

Site Status RECRUITING

Yonsei University Health System, Gangnam Severance Hospital

Seoul, , South Korea

Site Status NOT_YET_RECRUITING

Pusan National University Yangsan Hospital

Yangsan, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Bum Joon Kim, Professor

Role: CONTACT

Phone: +82-2- 3010-3981

Email: [email protected]

Facility Contacts

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Bum Joon Kim, MD, PhD

Role: primary

Hanjun Cho

Role: primary

Hee-yoon Chae, MD, PhD

Role: primary

Mi-Yeon Eun, MD, PhD

Role: primary

Jong Wook Shin, MD, PhD

Role: primary

Jae Guk Kim, MD, PhD

Role: primary

Kang-Ho Choi, MD, PhD

Role: primary

Beom Joon Kim, MD, PhD

Role: primary

Minwoo Lee, MD, PhD

Role: primary

Hyuk Sung Kwon, MD, PhD

Role: primary

Jin-Man Jung, MD, PhD

Role: primary

SangHee Ha, MD, PhD

Role: primary

Cindy W Yoon, MD, PhD

Role: primary

Joong Goo Kim, MD, PhD

Role: primary

Hyun Goo Kang, MD, PhD

Role: primary

Tae-Jin Song, MD, PhD

Role: primary

Youngseo Kim, MD, PhD

Role: primary

Chi Kyung Kim, MD, PhD

Role: primary

Kyung Chul Noh, MD, PhD

Role: primary

Hogeol Woo, MD, PhD

Role: primary

Woo Keun Seo, MD, PhD

Role: primary

Minhwan Lee, MD, PhD

Role: primary

Yo Han Jung, MD, PhD

Role: primary

Sungho Ahn, MD, PhD

Role: primary

Other Identifiers

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CHANGE

Identifier Type: -

Identifier Source: org_study_id