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

Ajou University School of Medicine

Status and phase: Completed; Phase 4

Conditions: Ischemic Stroke; Endothelial Dysfunction

Treatments: Drug: Cilostazol 100mg; Drug: Aspirin

Study type: Interventional

Funder types: Other

Identifiers

NCT03116269

AJIRB MED CT4 10-239

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 30+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups

cilostazol group

Experimental group

Description:

aspirin placebo daily and 100 mg cilostazol twice daily

Treatment:

Drug: Cilostazol 100mg

aspirin group

Active Comparator group

Description:

100 mg aspirin daily and cilostazol placebo twice daily

Treatment:

Drug: Aspirin