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.
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.
- Aspirin Drug
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
|Type||Measure||Time Frame||Safety Issue|
|Primary||flow mediated dilation||3 month change|