ongoing

The CLEAR SYNERGY (Organization to Assess Strategies for Ischemic Syndromes OASIS 9) randomized controlled 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).

Primary Endpoints:

For the 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.

For the 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.

CLEAR SYNERGY Protocol - Download PDF
Study Type

Interventional - Drug

Study Design

2x2 Factorial Blinded RCT with Registry

NO. of Countries

10

NO. of Sites

70

NO. of Participants

4000

Study Period

2018 - 2025

Sponsor

PHRI

Boston Scientific

Canadian Institutes of Health Research (CIHR)

BSC Investigator-Sponsored Research Grant

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