Non ST Elevation Myocardial Infarction, ST Elevation Myocardial Infarction
Conditions
Brief summary
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).
Detailed description
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).
Interventions
DRUGColchicine
Colchicine 0.5 mg once daily
DRUGSpironolactone
Spironolactone 25 mg once daily
DEVICESYNERGY Bioabsorbable Polymer Drug-Eluting Stent
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.
Matching Colchicine-placebo once daily
DRUGSpironolactone-Placebo
Matching Spironolactone-Placebo once daily
Sponsors
Boston Scientific Corporation
Canadian Institutes of Health Research (CIHR)
Population Health Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
double-dummy masking of colchicine and spironolactone in 2x2 factorial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. a) Patients with STEMI referred for PCI within 12 hours of symptom onset, have a culprit lesion amenable to stenting, and with planned SYNERGY stent implantation for SYNERGY registry OR b) Patients with STEMI referred for PCI within 48 hours of symptom onset, not prospectively enrolled in SYNERGY stent registry OR c) Patients with diagnosis of Non STEMI with ischemic symptoms and either Hs Troponin \> or = 300x ULN or Troponin \> or = 200x ULN who have undergone PCI with one of the following: i. LVEF\< or =45% ii. Diabetes iii. Multivessel CAD defined as 50% stenosis in 2nd major epicardial vessel iv. Prior MI v. Age \>60 years 2. Able to be enrolled/randomized within 72 hours of index PCI (however patients should be randomized as soon as possible after PCI) 3. Written informed consent
Exclusion criteria
1. Age ≤18 years 2. Pregnancy, breastfeeding, or women of childbearing potential who are not using an effective method of contraception 3. Any medical, geographic, or social factor making study participation impractical or precluding required follow-up 4. Systolic blood pressure \<90 mm Hg 5. Active diarrhea 6. Known allergy or contraindication to everolimus, the SYNERGY stent or any of its components 7. Unable to receive dual antiplatelet therapy 8. Any contraindication or known intolerance to colchicine or spironolactone 9. Requirement for colchicine or mineralocorticoid antagonist for another indication 10. History of cirrhosis or current severe hepatic disease 11. Current or planned use of any of: cyclosporine, verapamil, HIV protease inhibitors, azole antifungals, or macrolide antibiotics 12. Creatinine clearance \<30 mL/min/1.73 m2 13. Serum Potassium \>5.0 meq/L
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major Adverse Cardiac Events (MACE) | up to 1 year | 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 |
| Composite of cardiovascular death, recurrent myocardial infarction, stroke, or unplanned ischemia driven revascularization | through study completion, an estimated average of 3 years | The first occurrence of cardiovascular death, recurrent myocardial infarction, stroke, or unplanned ischemia driven revascularization in the colchicine comparison |
| Total composite events of cardiovascular death or new or worsening heart failure (co-primary 1) | through study completion, an estimated average of 3 years | Total composite of cardiovascular death or new or worsening heart failure in the spironolactone comparison (co-primary 1) |
| Composite of cardiovascular death, new or worsening heart failure, recurrent myocardial infarction, or stroke (co-primary 2) | through study completion, an estimated average of 3 years | The first occurence of cardiovascular death, new or worsening heart failure, recurrent myocardial infarction, or stroke in the spironolactone comparison (co-primary 2) |
Countries
Australia, Canada, Czechia, Egypt, France, Hungary, Nepal, Netherlands, North Macedonia, Serbia, Spain, Switzerland, United Kingdom, United States
Outcome results
None listed