The CLEAR SYNERGY trial will study the long term effects of treatments following PCI to treat 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).
This is a multicenter, international SYNERGY stent registry that is embedded within a randomized, blinded, double-dummy, 2x2 factorial design trial of colchicine versus placebo and spironolactone versus placebo in patients with myocardial infarction who have undergone primary percutaneous coronary intervention (PCI).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
7,264
Colchicine 0.5 mg once daily
Spironolactone 25 mg once daily
Trial participants who receive a SYNERGY™ Bioabsorbable Polymer Drug-Eluting (everolimus) Stent during their index PCI for STEMI will be included in the SYNERGY Stent Registry.
Major Adverse Cardiac Events (MACE)
Major Adverse Cardiac Events (MACE) for SYNERGY Stent (defined as the composite of death, recurrent target vessel MI, stroke, or ischemia driven target vessel revascularization) compared to performance goal
Time frame: up to 1 year
Composite of cardiovascular death, recurrent myocardial infarction, stroke, or unplanned ischemia driven revascularization
The first occurrence of cardiovascular death, recurrent myocardial infarction, stroke, or unplanned ischemia driven revascularization in the colchicine comparison
Time frame: through study completion, an estimated average of 3 years
Total composite events of cardiovascular death or new or worsening heart failure (co-primary 1)
Total composite of cardiovascular death or new or worsening heart failure in the spironolactone comparison (co-primary 1)
Time frame: through study completion, an estimated average of 3 years
Composite of cardiovascular death, new or worsening heart failure, recurrent myocardial infarction, or stroke (co-primary 2)
The first occurence of cardiovascular death, new or worsening heart failure, recurrent myocardial infarction, or stroke in the spironolactone comparison (co-primary 2)
Time frame: through study completion, an estimated average of 3 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Matching Colchicine-placebo once daily
Matching Spironolactone-Placebo once daily
Central Cardiology
Bakersfield, California, United States
Medstar Washington Hospital Center
Washington D.C., District of Columbia, United States
University of Illinois
Chicago, Illinois, United States
Prairie Education & Research Cooperative
Springfield, Illinois, United States
Community Hospital
Munster, Indiana, United States
Lahey Hospital and Medical Center
Burlington, Massachusetts, United States
New Mexico Heart Institute
Albuquerque, New Mexico, United States
NYU Langone Medical Center
New York, New York, United States
The Christ Hospital Lindner Research Center
Cincinnati, Ohio, United States
Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
...and 99 more locations