Clinical trial NCT00446641: Overcome Biochemical Aspirin Resistance Through Cilostazol Combination
Official title: Phase 4 Study of Additional Cilostazol for Overcoming Biochemical Aspirin Resistance in the Chronic Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cerebral Infarction
Keywords: Infarction, Cerebral
Cilostazol
Aspirin Resistance
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: Korea Otsuka Pharmaceutical Co., Ltd.
First posted: 2007-03-13
Enrollment: 244
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Aspirin Resistance (ARU ≥ 550)
timeFrame: 4 weeks after treatment
Secondary outcomes:
measure: Aspirin Resistance (ARU ≥ 500)
timeFrame: 4 weeks after reatment
measure: Bleeding Time (BT)
timeFrame: 4 weeks after reatment
measure: Fatal or Major Bleeding Complications;
timeFrame: events ocurred during study medication after randomization
measure: Any Bleeding Complications
timeFrame: events ocurred during study medication after randomization
measure: Difference of Post-treatment ARU and Baseline ARU
timeFrame: baseline ARU measured at the randomization and post-treatment ARU measured at the 4weeks treatment with study medication
measure: Post-treatment ARU
timeFrame: after 4 weeks treatment
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Jae-Kwan Cha
city: Daejon
country: Korea, Republic of
facility: Eulji University Hospital
city: Seoul
country: Korea, Republic of
facility: Kangdong Sacred Heart Hospital, Hallym University
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center, Univsersity of Ulsan, Medical College
name: Sun U Kwon, MD. PhD.
role: PRINCIPAL_INVESTIGATOR
References: