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

Phase 4

Completed

• Conditions: Ischemic Stroke; Endothelial Dysfunction
• Interventions: Drug: Cilostazol 100mg; Drug: Aspirin

• Registration Number: NCT03116269
• Lead Sponsor: Ajou University School of Medicine

Brief Summary

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

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 Timeline

• Study Start: 2012-03-01
• Primary Completion: 2014-10-31
• Study Completion: 2014-10-31
• Status Verified: 2017-04
• Study First Submitted: 2017-04-12
• Study First Submitted QC: 2017-04-12
• Last Update Submitted: 2017-04-12
• Study First Posted: 2017-04-17
• Last Update Posted: 2017-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
cilostazol group	Cilostazol 100mg	aspirin placebo daily and 100 mg cilostazol twice daily
aspirin group	Aspirin	100 mg aspirin daily and cilostazol placebo twice daily

Primary Outcome Measures

Name	Time	Method
flow mediated dilation	3 month change	flow mediated dilation of the brachial artery in response to hyperemia

Trial Locations

Locations (1)

Ajou University Medical Center; 🇰🇷 Suwon, Gyunggido, Korea, Republic of