Cilostazol Stroke Prevention Study for Antiplatelet Combination

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

1884 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-13

Study Completion Date

2018-12-07

Brief Summary

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To examine the efficacy and safety of dual antiplatelet therapy (DAPT) including cilostazol (Pletaal OD Tablet ®) in comparison with antiplatelet monotherapy (excluding cilostazol) for secondary prevention of ischemic stroke in high-risk patients for stroke

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Detailed Description

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Conditions

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Noncardioembolic Cerebral Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Monotherapy group

Aspirin (81mg or 100mg) or clopidogrel (50mg or 75mg) will be orally administered once daily.

The treatment period will begin with the first visit of the first subject and end one year after the first visit of the last subject.

Group Type ACTIVE_COMPARATOR

aspirin

Intervention Type DRUG

Aspirin (81mg or 100mg) will be orally administered once daily.The treatment period will begin with the first visit of the first subject and end one year after the first visit of the last subject.

clopidogrel

Intervention Type DRUG

Clopidogrel (50mg or 75mg) will be orally administered once daily.The treatment period will begin with the first visit of the first subject and end one year after the first visit of the last subject.

DAPT group

Cilostazol (100mg twice daily) will be orally administered in combination with aspirin (81 or 100mg once daily) or clopidogrel (50 or 75mg once daily).

The treatment period will begin with the first visit of the first subject and end one year after the first visit of the last subject.

Group Type EXPERIMENTAL

aspirin

Intervention Type DRUG

Aspirin (81mg or 100mg) will be orally administered once daily.The treatment period will begin with the first visit of the first subject and end one year after the first visit of the last subject.

clopidogrel

Intervention Type DRUG

Clopidogrel (50mg or 75mg) will be orally administered once daily.The treatment period will begin with the first visit of the first subject and end one year after the first visit of the last subject.

cilostazol

Intervention Type DRUG

Cilostazol (100mg twice daily) will be orally administered. The treatment period will begin with the first visit of the first subject and end one year after the first visit of the last subject.

Interventions

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aspirin

Aspirin (81mg or 100mg) will be orally administered once daily.The treatment period will begin with the first visit of the first subject and end one year after the first visit of the last subject.

Intervention Type DRUG

clopidogrel

Clopidogrel (50mg or 75mg) will be orally administered once daily.The treatment period will begin with the first visit of the first subject and end one year after the first visit of the last subject.

Intervention Type DRUG

cilostazol

Cilostazol (100mg twice daily) will be orally administered. The treatment period will begin with the first visit of the first subject and end one year after the first visit of the last subject.

Intervention Type DRUG

Other Intervention Names

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Bayaspirin Plavix Pletaal OD Tablet

Eligibility Criteria

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Inclusion Criteria

* Patients with a diagnosis of noncardioembolic IS that developed between 8 and 180 days before the start of the protocol treatment
* Patients with a responsible lesion identified by MRI
* Patients aged 20 to 85 years old when providing informed consent
* Patients taking clopidogrel or aspirin alone as antiplatelet therapy when providing informed consent
* Patients meeting at least one of the following criteria a-c:

1. at least 50% stenosis of a major intracranial artery (to the level of A2, M2, or P2)
2. at least 50% stenosis of an extracranial artery (the common carotid artery，internal carotid artery，vertebral artery，brachiocephalic artery，or subclavian artery)
3. Two or more of the following risk factors

* Aged 65 years or more
* Diabetes mellitus
* Hypertension
* Peripheral arterial disease
* Chronic kidney disease
* History of IS (excluding the index IS for this study)
* History of ischemic heart disease
* Smoking (only current smokers)
* Patients considered to be able to visit the study site for ambulatory care throughout the observation period
* Patients who provided written informed consent

Exclusion Criteria

* Patients with emboligenic heart disease
* Patients taking any anticoagulant agents
* Patients who cannot undergo MRI examination for reasons such as claustrophobia and implanted pacemaker
* Patients scheduled to undergo any surgery, such as percutaneous angioplasty, stent placement, and bypass grafting, during the study period
* Patients with a drug-eluting coronary stent implanted within one year
* Patients with a history of symptomatic non-traumatic intracranial hemorrhage, any other hemorrhagic disease (eg, active peptic ulcer), bleeding predisposition, or blood clotting disorders
* Patients with a history of hypersensitivity to cilostazol
* Patients with congestive heart failure or uncontrolled angina pectoris
* Patients with thrombocytopenia (platelet count ≦ 100,000/mm3)
* Patients with severe liver or renal dysfunction
* Women who are pregnant, breast-feeding, or of child-bearing potential
* Patients with a malignant tumor requiring treatment
* Patients who are taking aspirin, and meet any of the following criteria:

* History of hypersensitivity to aspirin or salicylic acid analogues
* Current peptic ulcer
* Aspirin-induced asthma or its history
* Patients who are taking clopidogrel, and meet the following criterion:

・History of hypersensitivity to clopidogrel
* Patients who are participating in any other clinical studies
* Patients considered by the investigator/subinvestigator to be unsuitable for participating in this study

Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No