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).
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
Interventional - Drug
2x2 Factorial Blinded RCT with Registry
2018 - 2025
Sanjit Jolly is an interventional cardiologist at Hamilton Health Sciences and associate professor at McMaster University. He has formal training in clinical trials with a M.Sc. in Health Research Methodology from McMaster. He was the principal investigator of the RIVAL trial, a randomized trial of 7021 patients comparing radial and femoral access for coronary intervention. He is also the principal investigator trial of the ongoing TOTAL trial, an international randomized trial (N=10,700) of thrombectomy during primary PCI.
Study Team Specialist
Heather Beresh has worked at PHRI since May 2002, largely devoted to managing global, multi-centre clinical trials of antithrombotic therapies in patients with atrial fibrillation (AF). She started as research coordinator for the ACTIVE study evaluating dual antiplatelet therapy and angiotensin receptor blockers in patients with AF, then continued with oversight of the AVERROES open label extension trial evaluating a novel oral anticoagulant in the same population, and ARTESiA evaluating anticoagulant therapy in patients with subclinical AF.
After years as Associate Program Manager for the Heart Failure and Arrhythmia Program, managing networks such as C-SPIN, and on the ACT COVI-19 research program, Heather was made Study Team Specialist in 2021, to provide regulatory, country and site management expertise to the studies in the Global Health research team. She has as a Master’s degree in Medical Sciences from McMaster University.
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