Colchicine and Spironolactone in Patients With MI / SYNERGY Stent Registry

• Status: Recruiting
• Trial end date: 2025-03-30
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Population Health Research Institute
• Collaborators: Boston Scientific Corporation; BSC; Canadian Institutes of Health Research (CIHR)
• Treatments: Colchicine; Spironolactone

Criteria

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

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