Phase 4
N=244
Overcome Biochemical Aspirin Resistance Through Cilostazol Combination
Cerebral Infarction
Bottom Line
View on ClinicalTrials.gov: NCT00446641 ↗Enrolled (actual)
244
Serious AEs
0.0%
Results posted
Jan 2010
Primary outcome: Primary: Aspirin Resistance (ARU ≥ 550) — 9; 11 participants — p=0.654
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Cilostazol (Drug); placebo (Drug)
- Age
- Adult, Older Adult · 35+ yrs
- Sex
- All
- Sponsor
- Asan Medical Center
- Primary completion
- Jun 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Aspirin Resistance (ARU ≥ 550) |
9; 11 | 0.654 |
| SECONDARY Aspirin Resistance (ARU ≥ 500) |
20; 28 | — |
| SECONDARY Bleeding Time (BT) |
113; 106 | — |
| SECONDARY Fatal or Major Bleeding Complications; |
0; 0 | — |
| SECONDARY Any Bleeding Complications |
0; 0 | — |
| SECONDARY Difference of Post-treatment ARU and Baseline ARU |
-7.8; 12.1 | — |
| SECONDARY Post-treatment ARU |
454.8; 473.6 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00446641). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.