Overcome Biochemical Aspirin Resistance Through Cilostazol Combination

Phase 4

Completed

Brief Summary: 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.

Detailed Description: \[Goal\] 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

Recruitment & Eligibility

Inclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	matching placebo to cilostazol
1 Cilostazol	Cilostazol	100mg of Cilostazol twice a day

Primary Outcome Measures

Name	Time	Method
Aspirin Resistance (ARU ≥ 550)	4 weeks after treatment	The number of patients with aspirin reaction units (ARUs) values ≥ 550 on the Ultra Rapid Platelet Function Assay-ASA among the recruited patients

Secondary Outcome Measures

Name	Time	Method
Aspirin Resistance (ARU ≥ 500)	4 weeks after reatment	The number of participants with ARUs values ≥500 on the Ultra Rapid Platelet Function Assay-ASA; ARUs values
Bleeding Time (BT)	4 weeks after reatment	for evaluation of the extent of the bleeding time prolongation by additional cilostazol
Fatal or Major Bleeding Complications;	events ocurred during study medication after randomization	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
Any Bleeding Complications	events ocurred during study medication after randomization	any bleeding events causing medical attention
Difference of Post-treatment ARU and Baseline ARU	baseline ARU measured at the randomization and post-treatment ARU measured at the 4weeks treatment with study medication	summation of change of ARU (posttreatment ARU - baseline ARU) of individual patients
Post-treatment ARU	after 4 weeks treatment	mean of ARU value of individual participants after 4 weeks treatment

Locations (4): Jae-Kwan Cha
🇰🇷
Busan, Korea, Republic of
Kangdong Sacred Heart Hospital, Hallym University
🇰🇷
Seoul, Korea, Republic of
Eulji University Hospital
🇰🇷
Daejon, Korea, Republic of
Asan Medical Center
🇰🇷
Seoul, Korea, Republic of