Colchicine and Spironolactone in Patients with MI / SYNERGY Stent Registry

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).

Inclusion criteria

• 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

• Able to be enrolled/randomized within 72 hours of index PCI (however patients should be randomized as soon as possible after PCI)
• Written informed consent

Exclusion criteria

• Age ≤18 years
• Pregnancy, breastfeeding, or women of childbearing potential who are not using an effective method of contraception
• Any medical, geographic, or social factor making study participation impractical or precluding required follow-up
• Systolic blood pressure <90 mm Hg
• Active diarrhea
• Known allergy or contraindication to everolimus, the SYNERGY stent or any of its components
• Unable to receive dual antiplatelet therapy
• Any contraindication or known intolerance to colchicine or spironolactone
• Requirement for colchicine or mineralocorticoid antagonist for another indication
• History of cirrhosis or current severe hepatic disease
• Current or planned use of any of: cyclosporine, verapamil, HIV protease inhibitors, azole antifungals, or macrolide antibiotics
• Creatinine clearance <30 mL/min/1.73 m2
• Serum Potassium >5.0 meq/L