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

Ischemic Stroke Clinical Trial

— PASS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03116269
• Other study ID #: AJIRB MED CT4 10-239
• Status: Completed
• Phase: Phase 4
• First received: April 12, 2017
• Last updated: April 12, 2017
• Start date: March 1, 2012
• Est. completion date: October 31, 2014

Study information

• Verified date: April 2017
• Source: Ajou University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: October 31, 2014
• Est. primary completion date: October 31, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Brain Ischemia
• Cerebral Infarction
• Endothelial Dysfunction
• Ischemia
• Ischemic Stroke

Intervention

Drug:
• Cilostazol 100mg

• Aspirin

Locations

Country	Name	City	State
Korea, Republic of	Ajou University Medical Center	Suwon	Gyunggido

Sponsors (1)

Lead Sponsor	Collaborator
Ajou University School of Medicine

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	flow mediated dilation	flow mediated dilation of the brachial artery in response to hyperemia	3 month change