Colchicine and Spironolactone in Patients with MI / SYNERGY Stent Registry

Completed · Phase 3 · Has a placebo group

Conditions studied: ST Elevation Myocardial Infarction, Non ST Elevation Myocardial Infarction

In brief

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).

Key facts

Study ID

NCT03048825

Run by

Population Health Research Institute

People needed

7264

Starts

2018-02-01

Expected to finish

2024-08-09

Last updated by the study team

2024-10-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• Rhode Island Hospital — Providence, Rhode Island, United States
• Bankstown-Lidcombe hospital — Bankstown, New South Wales, Australia
• SWSLHD - Campbelltown — Campbelltown, New South Wales, Australia
• SWSLHD - Liverpool Hospital — Liverpool, New South Wales, Australia
• Royal North Shore Hospital — St Leonards, New South Wales, Australia
• Peninsula Health — Frankston, Victoria, Australia
• Royal Melbourne Hospital — Parkville, Victoria, Australia
• University of Alberta Hospital — Edmonton, Alberta, Canada
• Kelowna General Hospital — Kelowna, British Columbia, Canada
• Fraser Clinical Trials — New Westminster, British Columbia, Canada
• Victoria Heart Institute Foundation — Victoria, British Columbia, Canada
• William Osler Health — Brampton, Ontario, Canada
• Hamilton General Hospital — Hamilton, Ontario, Canada
• Kingston Health Science Centre — Kingston, Ontario, Canada
• St. Mary's General Hospital — Kitchener, Ontario, Canada
• Central Cardiology — Bakersfield, California, United States

Full record on ClinicalTrials.gov

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