The Effect of Cilostazol Compared to Aspirin on Endothelial Function in Acute Cerebral Ischemia Patients

Ajou University School of Medicine80 enrolled

Overview

Patients presenting with acute cerebral ischemic events are randomly assigned into aspirin (n=40) or cilostazol (n=40) group in a double-blinded manner. FMD is measured as a primary outcome at baseline (T0) and 90 days (T1). Serious and non-serious adverse events were described.

This investigator-initiated, randomized, double-blind trial is prospectively conducted with two-arm parallel treatment groups and a single dose scheme: 100 mg aspirin daily and cilostazol placebo twice daily versus aspirin placebo daily and 100 mg cilostazol twice daily. A total of 80 eligible patients is planned to be recruited. All included patients undergo diagnostic studies including routine blood tests and cardiologic work-ups. The primary outcome is differences in endothelial function in the two groups measured by means of FMD on admission and at 3 months. According to previous studies, the adverse effects in two groups are investigated.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Ischemic Stroke Endothelial Dysfunction

Interventions

Cilostazol 100mgDRUG

AspirinDRUG

Eligibility

Sex: ALLMin age: 30 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. acute ischemic stroke confirmed by diffusion weighted imaging 2. transient ischemic attack (TIA) within 7 days Exclusion Criteria: 1. there is intracranial hemorrhage on imaging study 2. patients is previously taking antiplatelets, vitamin K antagonists, factor Xa antagonists, or chronic treatment with systemic steroidal and non-steroidal anti-inflammatory drugs 3. patients who received fibrinolytics within the previous 48 hours 4. cognitive impairment interfering with the possibility of obtaining informed consent 5. pregnancy 6. participation in another pharmacological study 7. peptic ulcer disease or hematological abnormality 8. initial modified Barthel index \<30 points 9. liver function tests exceeding a 2-fold upper range value.

Locations (1)

Ajou University Medical Center

Suwon, Gyunggido, South Korea

Outcomes

Primary Outcomes

flow mediated dilation

flow mediated dilation of the brachial artery in response to hyperemia

Time frame: 3 month change

Data from ClinicalTrials.gov

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