Colchicine and Spironolactone in Patients with MI / SYNERGY Stent Registry

Prior treatment

• Unable to receive dual antiplatelet therapy

Other illness

• Known allergy or contraindication to everolimus, the SYNERGY stent or any of its components
• 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

Lab values

• Creatinine clearance \<30 mL/min/1.73 m2
• Serum Potassium \>5.0 meq/L

Age

• Age ≤18 years

Other

• 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
• Any contraindication or known intolerance to colchicine or spironolactone
• Requirement for colchicine or mineralocorticoid antagonist for another indication

• 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
  • Patients with STEMI referred for PCI within 48 hours of symptom onset, not prospectively enrolled in SYNERGY stent registry
  • OR
  • 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:
  • 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