Conditions: Cerebral Infarction
Keywords: Infarction, Cerebral Cilostazol Aspirin Resistance
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 244
Healthy volunteers: no

Brief 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

Arms:
arm 1: 100mg of Cilostazol twice a day arm 2: matching placebo to cilostazol

Interventions: intervention 1: Cilostazol intervention 2: placebo
Intervention descriptions: intervention 1: cilostazol 100mg twice a day for 4 weeks intervention 2: placebo 1 tablet twice a day matching for cilostazol

Protocol document: