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OpenTrials
Completed

NCT Number: NCT03116269

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

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.

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Key information

Conditions

Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Endothelial Dysfunction Nervous System Diseases Stroke Vascular Diseases

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ajou University Medical Center

Suwon, Gyunggido, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cilostazol 100mg

Drug

Aspirin

Drug

Primary outcomes

  1. flow mediated dilation

    Time frame: 3 month change

    flow mediated dilation of the brachial artery in response to hyperemia

Sponsors and collaborators

Lead sponsor

Ajou University School of Medicine

Other

Registry information

Official study title

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

Acronym: PASS

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Apr 17, 2017
Registry last updated
Apr 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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