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

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

Sponsors

Lead Sponsor: Ajou University School of Medicine

Source 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.

Overall Status Completed
Start Date March 1, 2012
Completion Date October 31, 2014
Primary Completion Date October 31, 2014
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
flow mediated dilation 3 month change
Enrollment 80
Condition
Intervention

Intervention Type: Drug

Intervention Name: Cilostazol 100mg

Arm Group Label: cilostazol group

Intervention Type: Drug

Intervention Name: Aspirin

Arm Group Label: aspirin group

Eligibility

Criteria:

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.

Gender: All

Minimum Age: 30 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Ji Man Hong Principal Investigator 82 31 219 5174
Location
Facility: Ajou University Medical Center
Location Countries

Korea, Republic of

Verification Date

April 2017

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Ajou University School of Medicine

Investigator Full Name: Ji Man Hong

Investigator Title: Associate proffessor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: cilostazol group

Type: Experimental

Description: aspirin placebo daily and 100 mg cilostazol twice daily

Label: aspirin group

Type: Active Comparator

Description: 100 mg aspirin daily and cilostazol placebo twice daily

Acronym PASS
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov