Overcome Biochemical Aspirin Resistance Through Cilostazol Combination

Asan Medical Center244 enrolled

Overview

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.

\[Goal\] 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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

244

Conditions

Cerebral Infarction

Interventions

CilostazolDRUG

cilostazol 100mg twice a day for 4 weeks

placeboDRUG

placebo 1 tablet twice a day matching for cilostazol

Eligibility

Sex: ALLMin age: 35 Years

Medical Language ↔ Plain English

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

Locations (4)

Jae-Kwan Cha

Busan, Busan, South Korea

Eulji University Hospital

Daejeon, South Korea

Kangdong Sacred Heart Hospital, Hallym University

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

Outcomes

Primary Outcomes

Aspirin Resistance (ARU ≥ 550)

The number of patients with aspirin reaction units (ARUs) values ≥ 550 on the Ultra Rapid Platelet Function Assay-ASA among the recruited patients

Time frame: 4 weeks after treatment

Secondary Outcomes

Aspirin Resistance (ARU ≥ 500)

The number of participants with ARUs values ≥500 on the Ultra Rapid Platelet Function Assay-ASA; ARUs values

Time frame: 4 weeks after reatment

Bleeding Time (BT)

for evaluation of the extent of the bleeding time prolongation by additional cilostazol

Time frame: 4 weeks after reatment

Fatal or Major Bleeding Complications;

Fatal or life-threatening bleeding was defined as any fatal bleeding event, a drop in hemoglobin of ≥ 50g/L, or significant hypotension with need for inotropic agents, symptomatic intracranial hemorrhage, or transfusion of ≥ 4 units of red-blood cells or equivalent amount of whole blood. Major bleeding was defined as significantly disabling bleedings, intraocular bleeding leading to significant visual loss, or bleeding requiring transfusion of ≤ 3 units of red-blood cells or equivalent amount of whole blood

Time frame: events ocurred during study medication after randomization

Any Bleeding Complications

any bleeding events causing medical attention

Time frame: events ocurred during study medication after randomization

Difference of Post-treatment ARU and Baseline ARU

summation of change of ARU (posttreatment ARU - baseline ARU) of individual patients

Time frame: baseline ARU measured at the randomization and post-treatment ARU measured at the 4weeks treatment with study medication

Data from ClinicalTrials.gov

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