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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-01

Study Completion Date

2014-10-31

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.

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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.

Conditions

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Ischemic Stroke Endothelial Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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cilostazol group

aspirin placebo daily and 100 mg cilostazol twice daily

Group Type EXPERIMENTAL

Cilostazol 100mg

Intervention Type DRUG

aspirin group

100 mg aspirin daily and cilostazol placebo twice daily

Group Type ACTIVE_COMPARATOR

Aspirin

Intervention Type DRUG

Interventions

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Cilostazol 100mg

Intervention Type DRUG

Aspirin

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No