NCT00446641

Overcome Biochemical Aspirin Resistance Through Cilostazol Combination

Phase 4 Study of Additional Cilostazol for Overcoming Biochemical Aspirin Resistance in the Chronic Stroke Patients

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 244 (actual)
• Sponsor: Asan Medical Center · Academic / Other
• Sex: All
• Age: 35 Years
• Healthy volunteers: Not accepted

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

Conditions

• Cerebral Infarction

Interventions

Type	Name	Description
DRUG	Cilostazol	cilostazol 100mg twice a day for 4 weeks
DRUG	placebo	placebo 1 tablet twice a day matching for cilostazol

Timeline

• Start date: 2007-03-01
• Primary completion: 2008-06-01
• Completion: 2008-07-01
• First posted: 2007-03-13
• Last updated: 2010-01-18
• Results posted: 2010-01-18

Locations

4 sites across 1 country: South Korea