Overcome Biochemical Aspirin Resistane Through Cilostazol Combination
Information source: Asan Medical Center
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cerebral Infarction
Intervention: Cilostazol (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Asan Medical Center Official(s) and/or principal investigator(s):
Sun U Kwon, MD. PhD., Principal Investigator, Affiliation: Asan Medical Center, Univsersity of Ulsan, Medical College
Overall contact:
Sun U Kwon, MD. PhD., Phone: 82-2-3010-3960, Email: sunuck@amc.seoul.kr
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
Ultegra Rapid Platelet Function Assay-ASA.
Clinical Details
Official title: Phase 4 Study of Additional Cilostazol for Overcoming Biochemical Aspirin Resistance in the Chronic Stroke Patients
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Rate of patients with aspirin reaction units (ARUs) values ≥550 on the Ultegra Rapid Platelet Function Assay-ASA
Secondary outcome: Rate of patients with ARUs values ≥500 on the Ultegra Rapid Platelet Function Assay-ASA; ARUs values;Bleeding time (BT); Fatal or major bleeding complications; Any bleeding complications
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:
• Rate of patients with aspirin reaction units (ARUs) values ≥550 on the Ultegra Rapid
Platelet Function Assay-ASA
Secondary outcome variables:
- Rate of patients with ARUs values ≥500 on the Ultegra Rapid Platelet Function Assay-ASA
- ARUs values
- Bleeding time (BT)
- Fatal or major bleeding complications
- Any bleeding complications
Eligibility
Minimum age: 35 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Sun U Kwon, MD. PhD., Phone: 82-2-3010-3960, Email: sunuck@amc.seoul.kr
Asan Medical Center, Seoul 138-736, Korea, Republic of; Recruiting
Sun U. Kwon, MD, PhD, Phone: 82-2-3010-3960, Email: sunuck@amc.seoul.kr
Kangdong Sacred Heart Hospital, Hallym University, SEOUL 134-701, Korea, Republic of; Recruiting
Ju-Hun Lee, Phone: 82-2-2224-2695, Email: leeforte@medimail.co.kr
Eulji University Hospital, Daejon 302-799, Korea, Republic of; Not yet recruiting
Soo Joo Lee, MD, Phone: 82-42-611-3431, Email: sjoolee@eulji.ac.kr
Jae-Kwan Cha, Busan 602-715, Korea, Republic of; Not yet recruiting
Jae-Kwan Cha, MD, PhD, Phone: 82-51-2405266, Email: nrcjk@unitel.co.kr
Additional Information
Starting date: March 2007
Ending date: October 2007
Last updated: March 12, 2007
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