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

Completed

Phase 4 Results N/A

Trial Description

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.

Conditions

Interventions

  • Aspirin Drug
    Other Names: clopidogrel; combination aspirin-dipyridamole
    ARM 1: Kind: Experimental
    Label: aspirin group
    Description: 100 mg aspirin daily and cilostazol placebo twice daily
  • Cilostazol 100mg Drug
    ARM 1: Kind: Experimental
    Label: cilostazol group
    Description: aspirin placebo daily and 100 mg cilostazol twice daily

Outcomes

Type Measure Time Frame Safety Issue
Primary flow mediated dilation 3 month change

Sponsors