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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Effect of Cilostazol Compared to Aspirin on Endothelial Function Measured by Flow Mediated Dilatation in Acute Cerebral Ischemia Patients

Conditions
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Ischemic Stroke, Endothelial Dysfunction

Intervention / Treatment
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* Drug: Cilostazol 100mg
* Drug: Aspirin


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

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cilostazol group<br>aspirin placebo daily and 100 mg cilostazol twice daily | Drug: Cilostazol 100mg<br> <br> |
| Active Comparator: aspirin group<br>100 mg aspirin daily and cilostazol placebo twice daily | Drug: Aspirin<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| flow mediated dilation | flow mediated dilation of the brachial artery in response to hyperemia | 3 month change |