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Photo for OASIS 9 - CLEAR SYNERGY

OASIS 9 - CLEAR SYNERGY

Official Title

Colchicine and Spironolactone in Patients with ST Elevation Myocardial Infarction + SYNERGY Stent Registry

Status

Ongoing

Overview

The CLEAR SYNERGY trial will study the long term effects of treatments following PCI to treat ST elevation myocardial infarction. These treatments address both the culprit artery (PCI with SYNERGY Stent) as well as the non-culprit arteries (randomization to routine colchicine and spironolactone).

Study Design

2×2 Factorial Randomized Controlled Trial with Registry

Primary Endpoint

SYNERGY STENT REGISTRY: Major Adverse Cardiac Events (MACE) for SYNERGY stent (defined as the composite of CV death, recurrent MI, or unplanned ischemia driven target vessel revascularization) compared to a historical performance goal within 1 year.

COLCHICINE AND SPIRONOLACTONE 2X2 FACTORIAL RCT:

Colchicine vs. Colchicine-Placebo: Time-to-event of the composite of cardiovascular death, recurrent MI, or stroke over the duration of follow-up. Spironolactone vs. Spironolactone-Placebo: Time-to-event of the composite of cardiovascular death or new or worsening heart failure over the duration of follow-up.

Spironolactone vs. Spironolactone-Placebo: Time-to-event of the composite of cardiovascular death or new or worsening heart failure over the duration of follow-up.

Number of Patients

4000

Number of Sites

70

Number of Countries

10

Study Period

2017-2020

Principal Investigator

Sanjit Jolly

Program Manager

Brandi Meeks

Research Coordinator

Chris Zapallow

Collaborators

Canadian Institutes of Health Research; Boston Scientific

For more information, please visit https://clinicaltrials.gov/ct2/show/NCT03048825