Overcome Biochemical Aspirin Resistance Through Cilostazol Combination

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

244 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2008-07-31

Brief Summary

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This study will recruit 316 ischemic stroke patients taking aspirin.

They will be randomly assigned into cilostazol group or placebo group. Every patients will take 200mg of cilostazol a day or placebo for 1 month.

The primary outcome variable of this study is rate of biochemical aspirin resistance on the Ultra Rapid Platelet Function Assay-ASA.

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Detailed Description

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\[Goal\] To reveal the effect and safety of additional cilostazol for overcoming biochemical aspirin resistance.

\[Trial Design\] Double-Blind, Placebo-Controlled, Randomized, Multicenter Trial

\[Participants\] Ischemic stroke patients taking aspirin

\[Methods\]

* Double-Blind, Placebo-Controlled, Randomized, Multicenter Trial
* Investigational product: Cilostazol 200mg (100mg twice per day)
* Concomitant medication: Aspirin 100 mg per day
* Medication Duration: 1 month

\[Outcome Variables\]

Primary Outcome Variable:

• the proportion of patients with aspirin reaction units (ARUs) values ≥550 on the Ultra Rapid Platelet Function Assay-ASA

Secondary outcome variables:

* the proportion of patients with ARUs values ≥500 on the Ultra Rapid Platelet Function Assay-ASA
* ARUs values
* Bleeding time (BT)
* Fatal or major bleeding complications
* Any bleeding complications

Conditions

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Cerebral Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1 Cilostazol

100mg of Cilostazol twice a day

Group Type EXPERIMENTAL

Cilostazol

Intervention Type DRUG

cilostazol 100mg twice a day for 4 weeks

Placebo

matching placebo to cilostazol

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

placebo 1 tablet twice a day matching for cilostazol

Interventions

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Cilostazol

cilostazol 100mg twice a day for 4 weeks

Intervention Type DRUG

placebo

placebo 1 tablet twice a day matching for cilostazol

Intervention Type DRUG

Other Intervention Names

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pletaal matching placebo of cilostazol

Eligibility Criteria

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Inclusion Criteria

* Symptomatic cerebral infarction documented on MRI or CT
* More than 35 years of age
* Patients taking aspirin 100mg a day for 2 weeks or more before randomization

Exclusion Criteria

* Patients taking any antiplatelets other than aspirin within 2 weeks before randomization
* Patients taking any anticoagulants within 2 weeks before randomization
* Patients taking thrombolytic therapy within 2 weeks before randomization
* Patients taking any NSAIDs within 2 weeks before randomization
* Patients who need to take NSAIDs regularly (e.g. rheumatic arthritis).
* Bleeding diathesis
* Chronic liver disease (ALT \> 100 or AST \> 100) or chronic renal disease (creatinine \> 3.0mg/dl)
* Anemia (hemoglobin \< 10mg/dl) or thrombocytopenia (platelet count less than 100,000/mm3)
* Pregnant or lactating patients
* Patients scheduled for angioplasty or revascularization procedures within 4 weeks
* Patients scheduled for any surgery or invasive procedures within 4 weeks
* Patients having acute coronary syndrome

Minimum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No