Overcome Biochemical Aspirin Resistance Through Cilostazol Combination "ARCC"

Completed

Phase 4 Results

Trial Description

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

Interventions

  • Cilostazol (Pletal®)Drug
    Other Names: Claudiasil
    Intervention Desc: cilostazol 100mg twice a day for 4 weeks
    ARM 1: Kind: Experimental
    Label: 1 Cilostazol
    Description: 100mg of Cilostazol twice a day
  • Placebo Drug
    Intervention Desc: placebo 1 tablet twice a day matching for cilostazol
    ARM 1: Kind: Experimental
    Label: Placebo
    Description: matching placebo to cilostazol

Trial Design

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

Patient Involvement

Patient will be on ASA prior to randomization. Patient will be randomized to either ASA and Cilostazol or ASA and placebo for 1 month. Subjects will have blood drawn for Ultegra Rapid Platelet Function Assay-ASA, ARU, and BT. Baseline MRI or CT to confirm cerebral infarction.

Outcomes

Type Measure Time Frame Safety Issue
Primary Rate of patients with aspirin reaction units (ARUs) values ?550 on the Ultegra Rapid Platelet Function Assay-ASA.
Secondary 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.
Primary Aspirin Resistance (ARU ≥ 550) 4 weeks after treatment No
Secondary Aspirin Resistance (ARU ≥ 500) 4 weeks after reatment No
Secondary Bleeding Time (BT) 4 weeks after reatment Yes
Secondary Fatal or Major Bleeding Complications; events ocurred during study medication after randomization Yes
Secondary Any Bleeding Complications events ocurred during study medication after randomization Yes
Secondary Difference of Post-treatment ARU and Baseline ARU baseline ARU measured at the randomization and post-treatment ARU measured at the 4weeks treatment with study medication No
Secondary Post-treatment ARU after 4 weeks treatment No

Sponsors