AzTrials
AzTrials

ST Elevation Myocardial InfarctionPhase 3CLEAR SYNERGYNCT03048825

Colchicine and Spironolactone in Patients with MI / SYNERGY Stent Registry

A Phase 3 study testing Colchicine, Spironolactone and SYNERGY Bioabsorbable Polymer Drug-Eluting Stent in people with ST Elevation Myocardial Infarction and Non ST Elevation Myocardial Infarction, run by Population Health Research Institute at 109 sites in 14 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Colchicine, Spironolactone and SYNERGY Bioabsorbable Polymer Drug-Eluting Stent
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
7,264 participants
Where
109 sitesin 14 countries
Study dates
1 Feb 2018to 9 Aug 2024
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

109 sites in 14 countries.

109 sites in 14 countries

Canada22 sites

  • William Osler Health

    Brampton, Ontario

  • University of Alberta Hospital

    Edmonton, Alberta

  • Hamilton General Hospital

    Hamilton, Ontario, L8L2X2

  • Kelowna General Hospital

    Kelowna, British Columbia

  • Kingston Health Science Centre

    Kingston, Ontario

  • St. Mary's General Hospital

    Kitchener, Ontario

  • London Health Sciences Centre

    London, Ontario

  • Jewish General Hospital

    Montreal, Quebec

  • Fraser Clinical Trials

    New Westminster, British Columbia

  • York PCI Group Inc

    Newmarket, Ontario

  • University of Ottawa Heart Institute

    Ottawa, Ontario

  • Institut Universitaire de Cardiologie et de Pneumologie - ULAVAL

    Québec, Quebec, G1V 4G5

  • PVRI - Regina General Hospital

    Regina, Saskatchewan

  • Niagara Health System

    Saint Catharines, Ontario

  • Royal University Hospital

    Saskatoon, Saskatchewan

  • Scarborough Cardiology Research Associates Inc.

    Scarborough Village, Ontario

  • CIUSSS de l'Estrie - CHUS - Hôpital Fleurimont

    Sherbrooke, Quebec

  • St. Michael's Hospital

    Toronto, Ontario

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario

  • Toronto General Hospital, University Health Network

    Toronto, Ontario

  • Victoria Heart Institute Foundation

    Victoria, British Columbia

  • Windsor Regional Hospital

    Windsor, Ontario

Other trials in Canada

Netherlands16 sites

  • Bernhoven Ziekenhuis

    's-Hertogenbosch, 5223 GV

  • ZiekenhuisGroepTwente (ZGT)

    Almelo, Overijssel, 7609PP

  • Flevoziekenhuis

    Almere Stad, Flevoland, 1315 RA

  • Gelre Ziekenhuizen

    Apeldoorn, Gelderland, 7334DZ

  • Rijnstate Ziekenhuis

    Arnhem, 6815 AD

  • Slingeland Ziekenhuis

    Doetinchem, 7009 BL

  • Albert Schweitzer ziekenhuis

    Dordrecht, 3318 AT

  • Gelderse Vallei Ziekenhuis

    Ede, 6716 RP

  • Admiraal de Ruyter Hospital

    Goes, 4462 RA

  • Beatrixziekenhuis

    Gorinchem, South Holland, 4204 AA

  • Groene Hart Ziekenhuis Gouda

    Gouda, 2803HH

  • St. Jansdal Ziekenhuis

    Harderwijk, Gelderland, 3844 DG

  • Tergooi Hospital

    Hilversum, North Holland, 1212VG

  • Radboud UMC

    Nijmegen, 6525 GA

  • Franciscus Gasthuis

    Rotterdam, South Holland, 3045PM

  • Haga Hospital

    The Hague, 2545AA

Other trials in Netherlands

United Kingdom13 sites

  • William Harvey Hospital -East Kent Hospitals University NHS Foundation Trust

    Ashford, Kent (county), TN24 0LZ

  • University Hospitals Dorset NHS Foundation Trust

    Bournemouth, Dorset (county), BH7 7DW

  • Brighton & Sussex University Hospital NHS Trust

    Brighton, East Sussex (county), BN2 1ES

  • Ashford & St Peter's Hospitals NHS Foundation Trust

    Chertsey, Surrey (county), KT16 0PZ

  • Castle Hill Hospital

    Cottingham, East Riding of Yorkshire (unitary Authority), HU16 5JQ

  • Kettering General Hospital

    Kettering, Northamptonshire (county), NN16 8UZ

  • St. George's Hospital NHS Foundation Trust

    London, SW17OQT

  • The James Cook University Hospital

    Middlesbrough, TS4 3BW

  • Norfolk and Norwich University Hospital

    Norwich, Norfolk (county), NR4 7UY

  • Nottingham University Hospitals NHS Trust

    Nottingham, Nottinghamshire (county), NG5 1PB

  • Salisbury NHS Foundation Trust

    Salisbury, Wiltshire (county), SP2 8BJ

  • Sheffield Teaching Hospitals NHS Foundation Trust

    Sheffield, S57AU

  • Lister Hospital

    Stevenage, Hertfordshire (county), SG14AB

Other trials in United Kingdom

United States11 sites

  • New Mexico Heart Institute

    Albuquerque, New Mexico, 87102

  • Central Cardiology

    Bakersfield, California, 93308

  • Lahey Hospital and Medical Center

    Burlington, Massachusetts, 01805

  • University of Illinois

    Chicago, Illinois, 60612

  • The Christ Hospital Lindner Research Center

    Cincinnati, Ohio, 45219

  • Penn State Health Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033

  • Community Hospital

    Munster, Indiana, 46321

  • NYU Langone Medical Center

    New York, New York, 10016

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • Prairie Education & Research Cooperative

    Springfield, Illinois, 62769

  • Medstar Washington Hospital Center

    Washington D.C., District of Columbia, 20010

Other trials in United States

Spain10 sites

  • Germans Trias i Pujol University Hospital

    Badalona, 08916

  • Hospital del Mar

    Barcelona, Barcelona, 08003

  • Clínic Barcelona Hospital Universitario

    Barcelona, Barcelona, 08036

  • Hospital de Cabueñes

    Gijón, Principality of Asturias, 33394

  • Hospital Universitario Virgen de las Nieves

    Granada, Granada, 18014

  • Hospital Universitario de Bellvitge

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital Universitario Central de Asturias (HUCA)

    Oviedo, Principality of Asturias, 33011

  • Hospital Son Espases

    Palma, Balearic Islands, 07120

  • Hospital Álvaro Cunqueiro

    Vigo, 36312

Other trials in Spain

Egypt9 sites

  • Fayoum General Hospital

    Al Fayyum, 63511

  • Tamia Central Hospital

    Al Fayyum, 63711

  • Mansoura University Hospital

    Al Mansurah, Dakahlia Governorate, 35516

  • Alexandria University Hospital

    Alexandria, 21568

  • Beni Suef University Hospital

    Banī Suwayf, 62511

  • Nasser Institute for Research and Treatment

    Cairo, 11576

  • National Heart Institute

    Giza, 12651

  • Suez Canal University Hospital

    Ismailia, 41522

  • Kharga Specialized Hospital

    New Cairo, Kharga, 72738

Other trials in Egypt

Australia6 sites

  • Bankstown-Lidcombe hospital

    Bankstown, New South Wales, 2200

  • SWSLHD - Campbelltown

    Campbelltown, New South Wales, 2560

  • Peninsula Health

    Frankston, Victoria, 3199

  • SWSLHD - Liverpool Hospital

    Liverpool, New South Wales, 2170

  • Royal Melbourne Hospital

    Parkville, Victoria, 3050

  • Royal North Shore Hospital

    St Leonards, New South Wales, 2065

Other trials in Australia

Czechia4 sites

  • Czech Center University Hospital Brno

    Brno, 625 00

  • St. Anne´s University Hospital

    Brno, 656 91

  • Karlovarska krajska nemocnice a.s.

    Karlovy Vary, 36225

  • University Hospital Královské Vinohrady

    Prague, 10000

Other trials in Czechia

Serbia4 sites

  • Clinical Center of Serbia

    Belgrade, 11000

  • Institute for Cardiovascular Diseases Dedinje

    Belgrade, 11000

  • University Medical Center Zvezdara

    Belgrade, 11000

  • Institute of Cardiovascular Disease Vojvodina

    Kamenitz, 21208

Other trials in Serbia

France3 sites

  • Centre Hospitalier Universitaire de Caen

    Caen, Calvados, 14000

  • Centre Hospitalier Universitaire de Nimes

    Nîmes, 30 000

  • Institut de Cardiologie de la Pitié-Salpêtrière

    Paris, 75013

Other trials in France

Hungary3 sites

  • University of Debrecen

    Debrecen, 4032

  • Bács-Kiskun County Hospital

    Kecskemét, 6000

  • University of Szeged

    Szeged, 6725

Other trials in Hungary

Nepal3 sites

  • Chitwan Medical College Teaching Hospital

    Bharatpur, Bagmati Province/ State 3, 44200

  • Shahid Gangalal National Heart Centre

    Kathmandu, Maharajgung, 44600

  • Manmohan Cardiothoracic Vascular and Transplant Center

    Kathmandu, 44600

Other trials in Nepal

North Macedonia3 sites

  • PHI Clinical Hospital "Dr. Trifun Panovski"

    Bitola, 7000

  • University Clinic of Cardiology

    Skopje, 1000

  • Clinical Hospital Tetovo

    Tetovo, 1200

Other trials in North Macedonia

Switzerland2 sites

  • Hôpitaux Universitaires de Genève

    Geneva, 1205

  • Luzerner Kantonsspital

    Lucerne, 6000

Other trials in Switzerland

About this study

Official title: 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).

Read the 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).

Being tested
Colchicine, Spironolactone, SYNERGY Bioabsorbable Polymer Drug-Eluting Stent, Colchicine-Placebo, Spironolactone-Placebo
Medical subject headings
ST Elevation Myocardial Infarction, Non-ST Elevated Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ColchicineDrug

    Colchicine 0.5 mg once daily

  • SpironolactoneDrug

    Spironolactone 25 mg once daily

  • SYNERGY Bioabsorbable Polymer Drug-Eluting StentDevice

    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-PlaceboDrug

    Matching Colchicine-placebo once daily

  • Spironolactone-PlaceboDrug

    Matching Spironolactone-Placebo once daily

Study groups in NCT03048825
Study groupRoleWhat they receive
Colchicine + Spironolactone +/- SYNERGY StentActive comparatorColchicine 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.
Receives: Drug: Colchicine; Drug: Spironolactone; Device: SYNERGY Bioabsorbable Polymer Drug-Eluting Stent
Spironolactone +/- SYNERGY StentActive comparatorColchicine-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.
Receives: Drug: Spironolactone; Device: SYNERGY Bioabsorbable Polymer Drug-Eluting Stent; Drug: Colchicine-Placebo
Colchicine +/- SYNERGY StentActive comparatorColchicine 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.
Receives: Drug: Colchicine; Device: SYNERGY Bioabsorbable Polymer Drug-Eluting Stent; Drug: Spironolactone-Placebo
Placebo +/- SYNERGY StentPlacebo comparatorColchicine-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.
Receives: Device: SYNERGY Bioabsorbable Polymer Drug-Eluting Stent; Drug: Colchicine-Placebo; Drug: Spironolactone-Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Major Adverse Cardiac Events (MACE)

    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

    Measured: up to 1 year

  2. Composite of cardiovascular death, recurrent myocardial infarction, stroke, or unplanned ischemia driven revascularization

    The first occurrence of cardiovascular death, recurrent myocardial infarction, stroke, or unplanned ischemia driven revascularization in the colchicine comparison

    Measured: through study completion, an estimated average of 3 years

  3. Total composite events of cardiovascular death or new or worsening heart failure (co-primary 1)

    Total composite of cardiovascular death or new or worsening heart failure in the spironolactone comparison (co-primary 1)

    Measured: through study completion, an estimated average of 3 years

  4. Composite of cardiovascular death, new or worsening heart failure, recurrent myocardial infarction, or stroke (co-primary 2)

    The first occurence of cardiovascular death, new or worsening heart failure, recurrent myocardial infarction, or stroke in the spironolactone comparison (co-primary 2)

    Measured: through study completion, an estimated average of 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Feb 2017 (estimated)
  2. Study start1 Feb 2018
  3. Primary completion9 Aug 2024
  4. Study completion9 Aug 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
7,264 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03048825
Sponsor's protocol ID
CLSYN.1702
Other IDs
OASIS-9
Acronym
CLEAR SYNERGY
Status last verified
Oct 2024
First submitted
3 Feb 2017
Last updated
15 Oct 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
Yes
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 39555823

  • 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.

    PubMed 39555814

  • 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.

    PubMed 38936755

  • 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.

    PubMed 38505729

  • 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.

    PubMed 36526898

  • 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.

    PubMed 34269908

  • 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.

    PubMed 32648087

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Colchicine, Spironolactone and SYNERGY Bioabsorbable Polymer Drug-Eluting Stent in people with ST Elevation Myocardial Infarction and Non ST Elevation Myocardial Infarction, run by Population Health Research Institute at 109 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 109 sites in Canada, Netherlands, United Kingdom, United States, Spain and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Major Adverse Cardiac Events (MACE) (time frame: up to 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03048825, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.

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