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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03116269

Acronym

PASS

Enrollment

Registered

2017-04-17

Start date

2012-03-01

Completion date

2014-10-31

Last updated

2017-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic Stroke, Endothelial Dysfunction

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.

Interventions

DRUGCilostazol 100mg

DRUGAspirin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

30 Years to No maximum

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.

Design outcomes

Primary

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026