Colchicine and Spironolactone in Patients with MI / SYNERGY Stent Registry (CLEAR SYNERGY)

October 10, 2024 updated by: Population Health Research Institute

A 2x2 Factorial Randomized Controlled Trial of Colchicine and Spironolactone in Patients with Myocardial Infarction / SYNERGY Stent Registry - Organization to Assess Strategies for Ischemic Syndromes 9

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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).

Study Type

Interventional

Enrollment (Actual)

7264

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Bankstown, New South Wales, Australia, 2200
        • Bankstown-Lidcombe Hospital
      • Campbelltown, New South Wales, Australia, 2560
        • SWSLHD - Campbelltown
      • Liverpool, New South Wales, Australia, 2170
        • SWSLHD - Liverpool Hospital
      • St Leonards, New South Wales, Australia, 2065
        • Royal North Shore Hospital
    • Victoria
      • Frankston, Victoria, Australia, 3199
        • Peninsula Health
      • Parkville, Victoria, Australia, 3050
        • Royal Melbourne Hospital
  • Canada
      • Quebec, Canada, G1V 4G5
        • Institut Universitaire de Cardiologie et de Pneumologie - ULAVAL
    • Alberta
      • Edmonton, Alberta, Canada
        • University of Alberta Hospital
    • British Columbia
      • Kelowna, British Columbia, Canada
        • Kelowna General Hospital
      • New Westminster, British Columbia, Canada
        • Fraser Clinical Trials
      • Victoria, British Columbia, Canada
        • Victoria Heart Institute Foundation
    • Ontario
      • Brampton, Ontario, Canada
        • William Osler Health
      • Hamilton, Ontario, Canada, L8L2X2
        • Hamilton General Hospital
      • Kingston, Ontario, Canada
        • Kingston Health Science Centre
      • Kitchener, Ontario, Canada
        • St. Mary's General Hospital
      • London, Ontario, Canada
        • London Health Sciences Centre
      • Newmarket, Ontario, Canada
        • York PCI Group INC
      • Ottawa, Ontario, Canada
        • University of Ottawa Heart Institute
      • Saint Catharines, Ontario, Canada
        • Niagara Health System
      • Scarborough, Ontario, Canada
        • Scarborough Cardiology Research Associates Inc.
      • Toronto, Ontario, Canada
        • St. Michael's Hospital
      • Toronto, Ontario, Canada
        • Sunnybrook Health Sciences Centre
      • Toronto, Ontario, Canada
        • Toronto General Hospital, University Health Network
      • Windsor, Ontario, Canada
        • Windsor Regional Hospital
    • Quebec
      • Montreal, Quebec, Canada
        • Jewish General Hospital
      • Sherbrooke, Quebec, Canada
        • CIUSSS de l'Estrie - CHUS - Hôpital Fleurimont
    • Saskatchewan
      • Regina, Saskatchewan, Canada
        • PVRI - Regina General Hospital
      • Saskatoon, Saskatchewan, Canada
        • Royal University Hospital
  • Czechia
      • Brno, Czechia, 625 00
        • Czech Center University Hospital Brno
      • Brno, Czechia, 656 91
        • St. Anne´s University Hospital
      • Karlovy Vary, Czechia, 36225
        • Karlovarska krajska nemocnice a.s.
      • Prague, Czechia, 10000
        • University Hospital Královské Vinohrady
  • Egypt
      • Alexandria, Egypt, 21568
        • Alexandria University Hospital
      • Banī Suwayf, Egypt, 62511
        • Beni Suef university hospital
      • Cairo, Egypt, 11576
        • Nasser Institute for Research and Treatment
      • Fayoum, Egypt, 63511
        • Fayoum General Hospital
      • Fayoum, Egypt, 63711
        • Tamia Central Hospital
      • Giza, Egypt, 12651
        • National Heart Institute
      • Ismailia, Egypt, 41522
        • Suez Canal University Hospital
    • Dakahlia
      • Mansoura, Dakahlia, Egypt, 35516
        • Mansoura University Hospital
    • Kharga
      • New Cairo, Kharga, Egypt, 72738
        • Kharga Specialized Hospital
  • France
      • Nimes, France, 30 000
        • Centre Hospitalier Universitaire de Nīmes
      • Paris, France, 75013
        • Institut de Cardiologie de la Pitié-Salpêtrière
    • Calvados
      • Caen, Calvados, France, 14000
        • Centre Hospitalier Universitaire de Caen
  • Hungary
      • Debrecen, Hungary, 4032
        • University of Debrecen
      • Kecskemét, Hungary, 6000
        • Bacs-Kiskun County Hospital
      • Szeged, Hungary, 6725
        • University of Szeged
  • Nepal
      • Kathmandu, Nepal, 44600
        • Manmohan Cardiothoracic Vascular and Transplant Center
    • Bagmati Province/ State 3
      • Bharatpur, Bagmati Province/ State 3, Nepal, 44200
        • Chitwan Medical College Teaching Hospital
    • Maharajgung
      • Kathmandu, Maharajgung, Nepal, 44600
        • Shahid Gangalal National Heart Centre
  • Netherlands
      • 's-Hertogenbosch, Netherlands, 5223 GV
        • Bernhoven Ziekenhuis
      • Arnhem, Netherlands, 6815 AD
        • Rijnstate Ziekenhuis
      • Den Haag, Netherlands, 2545AA
        • Haga hospital
      • Doetinchem, Netherlands, 7009 BL
        • Slingeland Ziekenhuis
      • Dordrecht, Netherlands, 3318 AT
        • Albert Schweitzer Ziekenhuis
      • Ede, Netherlands, 6716 RP
        • Gelderse Vallei Ziekenhuis
      • Goes, Netherlands, 4462 RA
        • Admiraal de Ruyter Hospital
      • Gouda, Netherlands, 2803HH
        • Groene Hart Ziekenhuis Gouda
      • Nijmegen, Netherlands, 6525 GA
        • Radboud UMC
    • Flevoland
      • Almere, Flevoland, Netherlands, 1315 RA
        • Flevoziekenhuis
    • Gelderland
      • Apeldoorn, Gelderland, Netherlands, 7334DZ
        • Gelre Ziekenhuizen
      • Harderwijk, Gelderland, Netherlands, 3844 DG
        • St. Jansdal ziekenhuis
    • Noord Holland
      • Hilversum, Noord Holland, Netherlands, 1212VG
        • Tergooi Hospital
    • Overijssel
      • Almelo, Overijssel, Netherlands, 7609PP
        • ZiekenhuisGroepTwente (ZGT)
    • Zuid Holland
      • Gorinchem, Zuid Holland, Netherlands, 4204 AA
        • Beatrixziekenhuis
      • Rotterdam, Zuid Holland, Netherlands, 3045PM
        • Franciscus Gasthuis
  • North Macedonia
      • Bitola, North Macedonia, 7000
        • PHI Clinical Hospital "Dr. Trifun Panovski"
      • Skopje, North Macedonia, 1000
        • University Clinic of Cardiology
      • Tetovo, North Macedonia, 1200
        • Clinical Hospital Tetovo
  • Serbia
      • Belgrade, Serbia, 11000
        • Clinical Center of Serbia
      • Belgrade, Serbia, 11000
        • University Medical Center Zvezdara
      • Belgrade, Serbia, 11000
        • Institute for Cardiovascular diseases Dedinje
      • Sremska Kamenica, Serbia, 21208
        • Institute of Cardiovascular Disease Vojvodina
  • Spain
      • Badalona, Spain, 08916
        • Germans Trias i Pujol University Hospital
      • Barcelona, Spain, 08003
        • Hospital del Mar
      • Barcelona, Spain, 08036
        • Clínic Barcelona Hospital Universitario
      • Granada, Spain, 18014
        • Hospital Universitario Virgen De Las Nieves
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
      • Vigo, Spain, 36312
        • Hospital Alvaro Cunqueiro
    • Asturias
      • Gijon, Asturias, Spain, 33394
        • Hospital de Cabuenes
      • Oviedo, Asturias, Spain, 33011
        • Hospital Universitario Central de Asturias (HUCA)
    • Baleares
      • Palma, Baleares, Spain, 07120
        • Hospital Son Espases
    • Barcelona
      • l'Hospitalet de Llobregat, Barcelona, Spain, 08907
        • Hospital Universitario de Bellvitge
  • Switzerland
      • Geneva, Switzerland, 1205
        • Hopitaux Universitaires de Geneve
      • Luzern, Switzerland, 6000
        • Luzerner Kantonsspital
  • United Kingdom
      • London, United Kingdom, SW17OQT
        • St. George's Hospital NHS Foundation Trust
      • Middlesbrough, United Kingdom, TS4 3BW
        • The James Cook University Hospital
      • Sheffield, United Kingdom, S57AU
        • Sheffield Teaching Hospitals NHS Foundation Trust
    • Dorset (county)
      • Bournemouth, Dorset (county), United Kingdom, BH7 7DW
        • University Hospitals Dorset NHS Foundation Trust
    • East Riding of Yorkshire (unitary authority)
      • Cottingham, East Riding of Yorkshire (unitary authority), United Kingdom, HU16 5JQ
        • Castle Hill Hospital
    • East Sussex (county)
      • Brighton, East Sussex (county), United Kingdom, BN2 1ES
        • Brighton & Sussex University Hospital NHS Trust
    • Hertfordshire (county)
      • Stevenage, Hertfordshire (county), United Kingdom, SG14AB
        • Lister Hospital
    • Kent (county)
      • Ashford, Kent (county), United Kingdom, TN24 0LZ
        • William Harvey Hospital -East Kent Hospitals University NHS Foundation Trust
    • Norfolk (county)
      • Norwich, Norfolk (county), United Kingdom, NR4 7UY
        • Norfolk and Norwich University Hospital
    • Northamptonshire (county)
      • Kettering, Northamptonshire (county), United Kingdom, NN16 8UZ
        • Kettering General Hospital
    • Nottinghamshire (county)
      • Nottingham, Nottinghamshire (county), United Kingdom, NG5 1PB
        • Nottingham University Hospitals NHS Trust
    • Surrey (county)
      • Chertsey, Surrey (county), United Kingdom, KT16 0PZ
        • Ashford & St Peter's Hospitals NHS Foundation Trust
    • Wiltshire (county)
      • Salisbury, Wiltshire (county), United Kingdom, SP2 8BJ
        • Salisbury Nhs Foundation Trust
  • United States
    • California
      • Bakersfield, California, United States, 93308
        • Central Cardiology
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Medstar Washington Hospital Center
    • Illinois
      • Chicago, Illinois, United States, 60612
        • University of Illinois
      • Springfield, Illinois, United States, 62769
        • Prairie Education & Research Cooperative
    • Indiana
      • Munster, Indiana, United States, 46321
        • Community Hospital
    • Massachusetts
      • Burlington, Massachusetts, United States, 01805
        • Lahey Hospital and Medical Center
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • New Mexico Heart Institute
    • New York
      • New York, New York, United States, 10016
        • NYU Langone Medical Center
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • The Christ Hospital Lindner Research Center
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Penn State Health Milton S. Hershey Medical Center
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Rhode Island Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 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:

  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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 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.
Device: 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.
Drug: Spironolactone-Placebo
Matching Spironolactone-Placebo once daily
Drug: Colchicine-Placebo
Matching Colchicine-placebo once daily
Active Comparator: 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.
Drug: Spironolactone
Spironolactone 25 mg once daily
Device: 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.
Drug: Colchicine
Colchicine 0.5 mg once daily
Active Comparator: 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.
Drug: Spironolactone
Spironolactone 25 mg once daily
Device: 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.
Drug: Colchicine-Placebo
Matching Colchicine-placebo once daily
Active Comparator: 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.
Device: 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.
Drug: Spironolactone-Placebo
Matching Spironolactone-Placebo once daily
Drug: Colchicine
Colchicine 0.5 mg once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major Adverse Cardiac Events (MACE)
Time Frame: up to 1 year
Major Adverse Cardiac Events (MACE) for SYNERGY Stent (defined as the composite of death, recurrent target vessel MI, stroke, or ischemia driven target vessel revascularization) compared to performance goal
up to 1 year
Composite of cardiovascular death, recurrent myocardial infarction, stroke, or unplanned ischemia driven revascularization
Time Frame: through study completion, an estimated average of 3 years
The first occurrence of cardiovascular death, recurrent myocardial infarction, stroke, or unplanned ischemia driven revascularization in the colchicine comparison
through study completion, an estimated average of 3 years
Total composite events of cardiovascular death or new or worsening heart failure (co-primary 1)
Time Frame: through study completion, an estimated average of 3 years
Total composite of cardiovascular death or new or worsening heart failure in the spironolactone comparison (co-primary 1)
through study completion, an estimated average of 3 years
Composite of cardiovascular death, new or worsening heart failure, recurrent myocardial infarction, or stroke (co-primary 2)
Time Frame: through study completion, an estimated average of 3 years
The first occurence of cardiovascular death, new or worsening heart failure, recurrent myocardial infarction, or stroke in the spironolactone comparison (co-primary 2)
through study completion, an estimated average of 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Population Health Research Institute

Collaborators

Canadian Institutes of Health Research (CIHR)
Boston Scientific Corporation

Investigators

  • Principal Investigator: Sanjit S Jolly, MD, Population Health Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2018

Primary Completion (Actual)

August 9, 2024

Study Completion (Actual)

August 9, 2024

Study Registration Dates

First Submitted

February 3, 2017

First Submitted That Met QC Criteria

February 7, 2017

First Posted (Estimated)

February 9, 2017

Study Record Updates

Last Update Posted (Actual)

October 15, 2024

Last Update Submitted That Met QC Criteria

October 10, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLSYN.1702
  • OASIS-9 (Other Identifier: Population Health Research Institute)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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