Colchicine and Spironolactone in Patients with MI / SYNERGY Stent Registry
NCT ID: NCT03048825
Last Updated: 2024-10-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
7264 participants
INTERVENTIONAL
2018-02-01
2024-08-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
QUADRUPLE
Study Groups
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Colchicine + Spironolactone +/- SYNERGY Stent
Colchicine 0.5 mg tablet + Spironolactone 25 mg tablet.
Trial participants who receive a SYNERGY Bioabsorbable Polymer Drug-Eluting Stent during their index PCI for STEMI will be included in the embedded SYNERGY Stent Registry.
Colchicine
Colchicine 0.5 mg once daily
Spironolactone
Spironolactone 25 mg once daily
SYNERGY 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.
Spironolactone +/- SYNERGY Stent
Colchicine-placebo tablet + Spironolactone 25 mg tablet.
Trial participants who receive a SYNERGY Bioabsorbable Polymer Drug-Eluting Stent during their index PCI for STEMI will be included in the embedded SYNERGY Stent Registry.
Spironolactone
Spironolactone 25 mg once daily
SYNERGY 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.
Colchicine-Placebo
Matching Colchicine-placebo once daily
Colchicine +/- SYNERGY Stent
Colchicine 0.5 mg tablet + Spironolactone-placebo tablet.
Trial participants who receive a SYNERGY Bioabsorbable Polymer Drug-Eluting Stent during their index PCI for STEMI will be included in the embedded SYNERGY Stent Registry.
Colchicine
Colchicine 0.5 mg once daily
SYNERGY 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.
Spironolactone-Placebo
Matching Spironolactone-Placebo once daily
Placebo +/- SYNERGY Stent
Colchicine-placebo tablet + Spironolactone-placebo tablet.
Trial participants who receive a SYNERGY Bioabsorbable Polymer Drug-Eluting Stent during their index PCI for STEMI will be included in the embedded SYNERGY Stent Registry.
SYNERGY 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.
Colchicine-Placebo
Matching Colchicine-placebo once daily
Spironolactone-Placebo
Matching Spironolactone-Placebo once daily
Interventions
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Colchicine
Colchicine 0.5 mg once daily
Spironolactone
Spironolactone 25 mg once daily
SYNERGY 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.
Colchicine-Placebo
Matching Colchicine-placebo once daily
Spironolactone-Placebo
Matching Spironolactone-Placebo once daily
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Canadian Institutes of Health Research (CIHR)
OTHER_GOV
Population Health Research Institute
OTHER
Responsible Party
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Principal Investigators
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Sanjit S Jolly, MD
Role: PRINCIPAL_INVESTIGATOR
Population Health Research Institute
Locations
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Central Cardiology
Bakersfield, California, United States
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
London Health Sciences Centre
London, Ontario, Canada
York PCI Group Inc
Newmarket, Ontario, Canada
University of Ottawa Heart Institute
Ottawa, Ontario, Canada
Scarborough Cardiology Research Associates Inc.
Scarborough Village, Ontario, Canada
Niagara Health System
St. Catharines, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Toronto General Hospital, University Health Network
Toronto, Ontario, Canada
Windsor Regional Hospital
Windsor, Ontario, Canada
Jewish General Hospital
Montreal, Quebec, Canada
Institut Universitaire de Cardiologie et de Pneumologie - ULAVAL
Québec, Quebec, Canada
CIUSSS de l'Estrie - CHUS - Hôpital Fleurimont
Sherbrooke, Quebec, Canada
PVRI - Regina General Hospital
Regina, Saskatchewan, Canada
Royal University Hospital
Saskatoon, Saskatchewan, Canada
Czech Center University Hospital Brno
Brno, , Czechia
St. Anne´s University Hospital
Brno, , Czechia
Karlovarska krajska nemocnice a.s.
Karlovy Vary, , Czechia
University Hospital Královské Vinohrady
Prague, , Czechia
Mansoura University Hospital
Al Mansurah, Dakahlia Governorate, Egypt
Kharga Specialized Hospital
New Cairo, Kharga, Egypt
Fayoum General Hospital
Al Fayyum, , Egypt
Tamia Central Hospital
Al Fayyum, , Egypt
Alexandria University Hospital
Alexandria, , Egypt
Beni Suef University Hospital
Banī Suwayf, , Egypt
Nasser Institute for Research and Treatment
Cairo, , Egypt
National Heart Institute
Giza, , Egypt
Suez Canal University Hospital
Ismailia, , Egypt
Centre Hospitalier Universitaire de Caen
Caen, Calvados, France
Centre Hospitalier Universitaire de Nimes
Nîmes, , France
Institut de Cardiologie de la Pitié-Salpêtrière
Paris, , France
University of Debrecen
Debrecen, , Hungary
Bács-Kiskun County Hospital
Kecskemét, , Hungary
University of Szeged
Szeged, , Hungary
Chitwan Medical College Teaching Hospital
Bharatpur, Bagmati Province/ State 3, Nepal
Shahid Gangalal National Heart Centre
Kathmandu, Maharajgung, Nepal
Manmohan Cardiothoracic Vascular and Transplant Center
Kathmandu, , Nepal
Flevoziekenhuis
Almere Stad, Flevoland, Netherlands
Gelre Ziekenhuizen
Apeldoorn, Gelderland, Netherlands
St. Jansdal Ziekenhuis
Harderwijk, Gelderland, Netherlands
Tergooi Hospital
Hilversum, North Holland, Netherlands
ZiekenhuisGroepTwente (ZGT)
Almelo, Overijssel, Netherlands
Beatrixziekenhuis
Gorinchem, South Holland, Netherlands
Franciscus Gasthuis
Rotterdam, South Holland, Netherlands
Bernhoven Ziekenhuis
's-Hertogenbosch, , Netherlands
Rijnstate Ziekenhuis
Arnhem, , Netherlands
Slingeland Ziekenhuis
Doetinchem, , Netherlands
Albert Schweitzer ziekenhuis
Dordrecht, , Netherlands
Gelderse Vallei Ziekenhuis
Ede, , Netherlands
Admiraal de Ruyter Hospital
Goes, , Netherlands
Groene Hart Ziekenhuis Gouda
Gouda, , Netherlands
Radboud UMC
Nijmegen, , Netherlands
Haga Hospital
The Hague, , Netherlands
PHI Clinical Hospital "Dr. Trifun Panovski"
Bitola, , North Macedonia
University Clinic of Cardiology
Skopje, , North Macedonia
Clinical Hospital Tetovo
Tetovo, , North Macedonia
Clinical Center of Serbia
Belgrade, , Serbia
Institute for Cardiovascular Diseases Dedinje
Belgrade, , Serbia
University Medical Center Zvezdara
Belgrade, , Serbia
Institute of Cardiovascular Disease Vojvodina
Kamenitz, , Serbia
Hospital Son Espases
Palma, Balearic Islands, Spain
Hospital del Mar
Barcelona, Barcelona, Spain
Clínic Barcelona Hospital Universitario
Barcelona, Barcelona, Spain
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitario Virgen de las Nieves
Granada, Granada, Spain
Hospital de Cabueñes
Gijón, Principality of Asturias, Spain
Hospital Universitario Central de Asturias (HUCA)
Oviedo, Principality of Asturias, Spain
Germans Trias i Pujol University Hospital
Badalona, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Álvaro Cunqueiro
Vigo, , Spain
Hôpitaux Universitaires de Genève
Geneva, , Switzerland
Luzerner Kantonsspital
Lucerne, , Switzerland
University Hospitals Dorset NHS Foundation Trust
Bournemouth, Dorset (county), United Kingdom
Castle Hill Hospital
Cottingham, East Riding of Yorkshire (unitary Authority), United Kingdom
Brighton & Sussex University Hospital NHS Trust
Brighton, East Sussex (county), United Kingdom
Lister Hospital
Stevenage, Hertfordshire (county), United Kingdom
William Harvey Hospital -East Kent Hospitals University NHS Foundation Trust
Ashford, Kent (county), United Kingdom
Norfolk and Norwich University Hospital
Norwich, Norfolk (county), United Kingdom
Kettering General Hospital
Kettering, Northamptonshire (county), United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, Nottinghamshire (county), United Kingdom
Ashford & St Peter's Hospitals NHS Foundation Trust
Chertsey, Surrey (county), United Kingdom
Salisbury NHS Foundation Trust
Salisbury, Wiltshire (county), United Kingdom
St. George's Hospital NHS Foundation Trust
London, , United Kingdom
The James Cook University Hospital
Middlesbrough, , United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, , United Kingdom
Countries
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References
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Jolly SS, d'Entremont MA, Lee SF, Mian R, Tyrwhitt J, Kedev S, Montalescot G, Cornel JH, Stankovic G, Moreno R, Storey RF, Henry TD, Mehta SR, Bossard M, Kala P, Layland J, Zafirovska B, Devereaux PJ, Eikelboom J, Cairns JA, Shah B, Sheth T, Sharma SK, Tarhuni W, Conen D, Tawadros S, Lavi S, Yusuf S; CLEAR Investigators. Colchicine in Acute Myocardial Infarction. N Engl J Med. 2025 Feb 13;392(7):633-642. doi: 10.1056/NEJMoa2405922. Epub 2024 Nov 17.
Jolly SS, d'Entremont MA, Pitt B, Lee SF, Mian R, Tyrwhitt J, Kedev S, Montalescot G, Cornel JH, Stankovic G, Moreno R, Storey RF, Henry TD, Mehta SR, Bossard M, Kala P, Bhindi R, Zafirovska B, Devereaux PJ, Eikelboom J, Cairns JA, Natarajan MK, Schwalm JD, Sharma SK, Tarhuni W, Conen D, Tawadros S, Lavi S, Asani V, Topic D, Cantor WJ, Bertrand OF, Pourdjabbar A, Yusuf S; CLEAR investigators; CLEAR Investigators. Routine Spironolactone in Acute Myocardial Infarction. N Engl J Med. 2025 Feb 13;392(7):643-652. doi: 10.1056/NEJMoa2405923. Epub 2024 Nov 17.
d'Entremont MA, Lee SF, Mian R, Kedev S, Montalescot G, Cornel JH, Stankovic G, Moreno R, Storey RF, Henry TD, Skuriat E, Tyrwhitt J, Mehta SR, Devereaux PJ, Eikelboom J, Cairns JA, Pitt B, Jolly SS. Design and rationale of the CLEAR SYNERGY (OASIS 9) trial: A 2x2 factorial randomized controlled trial of colchicine versus placebo and spironolactone vs placebo in patients with myocardial infarction. Am Heart J. 2024 Sep;275:173-182. doi: 10.1016/j.ahj.2024.06.007. Epub 2024 Jun 25.
Akl E, Sahami N, Labos C, Genest J, Zgheib A, Piazza N, Jolly S. Meta-Analysis of Randomized Trials: Efficacy and Safety of Colchicine for Secondary Prevention of Cardiovascular Disease. J Interv Cardiol. 2024 Mar 12;2024:8646351. doi: 10.1155/2024/8646351. eCollection 2024.
Granger CB, Pocock SJ, Gersh BJ. The need for new clinical trials of old cardiovascular drugs. Nat Rev Cardiol. 2023 Feb;20(2):71-72. doi: 10.1038/s41569-022-00819-1. No abstract available.
Bouabdallaoui N, Tardif JC. Colchicine in the Management of Acute and Chronic Coronary Artery Disease. Curr Cardiol Rep. 2021 Jul 16;23(9):120. doi: 10.1007/s11886-021-01560-w.
Silvis MJM, Demkes EJ, Fiolet ATL, Dekker M, Bosch L, van Hout GPJ, Timmers L, de Kleijn DPV. Immunomodulation of the NLRP3 Inflammasome in Atherosclerosis, Coronary Artery Disease, and Acute Myocardial Infarction. J Cardiovasc Transl Res. 2021 Feb;14(1):23-34. doi: 10.1007/s12265-020-10049-w. Epub 2020 Jul 9.
Other Identifiers
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OASIS-9
Identifier Type: OTHER
Identifier Source: secondary_id
CLSYN.1702
Identifier Type: -
Identifier Source: org_study_id
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