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.
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.
Jessica Tyrwhitt has more than 10 years’ experience in coordinating and managing large, international clinical trials. She oversees interventional trials, registries, and observational research studies looking at primary and secondary prevention of cardiovascular disease in a variety of therapeutic areas, including cardiology, thrombosis, nephrology, cardio-oncology and diabetes.
She holds an Honours Bachelor of Science Degree & Business from the University of Waterloo.
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