Study Type
Interventional - Drug
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.
Interventional - Drug
2x2 Factorial Blinded RCT with Registry
13
101
6440
2018 - 2024
PHRI
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