search
Back to results

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

Primary Purpose

Ischemic Stroke, Endothelial Dysfunction

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Cilostazol 100mg
Aspirin
Sponsored by
Ajou University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Stroke

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Ajou University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

cilostazol group

aspirin group

Arm Description

aspirin placebo daily and 100 mg cilostazol twice daily

100 mg aspirin daily and cilostazol placebo twice daily

Outcomes

Primary Outcome Measures

flow mediated dilation
flow mediated dilation of the brachial artery in response to hyperemia

Secondary Outcome Measures

Full Information

First Posted
April 12, 2017
Last Updated
April 12, 2017
Sponsor
Ajou University School of Medicine
search

1. Study Identification

Unique Protocol Identification Number
NCT03116269
Brief Title
The Effect of Cilostazol Compared to Aspirin on Endothelial Function in Acute Cerebral Ischemia Patients
Acronym
PASS
Official Title
The Effect of Cilostazol Compared to Aspirin on Endothelial Function Measured by Flow Mediated Dilatation in Acute Cerebral Ischemia Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
March 1, 2012 (Actual)
Primary Completion Date
October 31, 2014 (Actual)
Study Completion Date
October 31, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ajou University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke, Endothelial Dysfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
cilostazol group
Arm Type
Experimental
Arm Description
aspirin placebo daily and 100 mg cilostazol twice daily
Arm Title
aspirin group
Arm Type
Active Comparator
Arm Description
100 mg aspirin daily and cilostazol placebo twice daily
Intervention Type
Drug
Intervention Name(s)
Cilostazol 100mg
Intervention Type
Drug
Intervention Name(s)
Aspirin
Primary Outcome Measure Information:
Title
flow mediated dilation
Description
flow mediated dilation of the brachial artery in response to hyperemia
Time Frame
3 month change

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ji Man Hong
Organizational Affiliation
82 31 219 5174
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ajou University Medical Center
City
Suwon
State/Province
Gyunggido
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
28851320
Citation
Lee SJ, Lee JS, Choi MH, Lee SE, Shin DH, Hong JM. Cilostazol improves endothelial function in acute cerebral ischemia patients: a double-blind placebo controlled trial with flow-mediated dilation technique. BMC Neurol. 2017 Aug 29;17(1):169. doi: 10.1186/s12883-017-0950-y.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs