Overcome Biochemical Aspirin Resistance Through Cilostazol Combination — ARCC  

Cerebral Infarction Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Infarction
• Infarction

• NCT number: NCT00446641
• Study type: Interventional
• Source: Asan Medical Center
• Status: Completed
• Phase: Phase 4
• Start date: March 2007
• Completion date: July 2008