CLARITY Trial: Cilostazol for Prevention of Recurrent Stroke Trial

TRIAL SUMMARY:

Abstract: Clarity is a Phase 3, randomized, double-blind, placebo-controlled, clinical trial of cilostazol in patients with a history of a non-cardioembolic ischemic stroke or high-risk TIA. Participants will be recruited at approximately 100 sites. Participants will be followed for a maximum of 5 years for the primary outcome of a major adverse cardiovascular event (MACE).

Objective:  The primary goal of this trial is to determine if the addition of cilostazol to standard-of-care treatment with aspirin or clopidogrel reduces the risk of major adverse cardiovascular events in patients with a history of a non-cardioembolic ischemic stroke or high-risk TIA.

Endpoints: Primary: Time to first occurrence of ischemic stroke, acute myocardial infarction, or cardiovascular death (MACE). Secondary: Time to first occurrence of ischemic stroke Safety: Time to first occurrence of major hemorrhage.

Population:  Patients with a recent (within 180 days) non-cardioembolic ischemic stroke or high-risk TIA (defined by ABCD2 score ≥6) who are treated with standard-of-care single antiplatelet therapy with aspirin or clopidogrel.

Target sample size: 2,000 (final sample size may differ from the target based on the results of sample-size re-estimation and/or interim analyses)

Phase: 3
Number of site: Approximately 100
Investigational drug: Cilostazol
Control: Placebo tablets matched to the cilostazol tablets

Intervention: Participants will be randomized to the active treatment (cilostazol) or control (placebo) arm. All participants will start with a reduced dose (1 tablet daily) and will increase to the full dose (1 tablet twice daily) after having been on the reduced dose for 2 weeks. Participants will stay on the full dose for the remainder of their participation in the study.

Study duration:  6 years
Participant duration:  Maximum of 5 years
Funding Source:  NIH / NINDS