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

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ClinicalTrials.gov Identifier: NCT03048825
Recruitment Status : Recruiting
First Posted : February 9, 2017
Last Update Posted : September 16, 2020
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
BSC
Information provided by (Responsible Party):
Population Health Research Institute

Brief 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).

Condition or disease Intervention/treatment Phase
ST Elevation Myocardial Infarction Non ST Elevation Myocardial Infarction Drug: Colchicine Drug: Spironolactone Device: SYNERGY Bioabsorbable Polymer Drug-Eluting Stent Drug: Colchicine-Placebo Drug: Spironolactone-Placebo Phase 3

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 7000 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: double-dummy masking of colchicine and spironolactone in 2x2 factorial
Primary Purpose: Treatment
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
Actual Study Start Date : February 1, 2018
Estimated Primary Completion Date : May 30, 2024
Estimated Study Completion Date : March 30, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
Experimental: 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: Colchicine
Colchicine 0.5 mg twice daily

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.

Experimental: 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 twice daily

Experimental: 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.

Drug: Colchicine
Colchicine 0.5 mg twice 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: Spironolactone-Placebo
Matching Spironolactone-Placebo once daily

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: Colchicine-Placebo
Matching Colchicine-placebo twice daily

Drug: Spironolactone-Placebo
Matching Spironolactone-Placebo once daily




Primary Outcome Measures :
  1. 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

  2. Composite of cardiovascular death, recurrent myocardial infarction, or stroke [ Time Frame: through study completion, an estimated average of 2 years ]
    The first occurrence of cardiovascular death, recurrent myocardial infarction, or stroke in the colchicine comparison

  3. Composite of cardiovascular death or new or worsening heart failure [ Time Frame: through study completion, an estimated average of 2 years ]
    The first occurrence of cardiovascular death or new or worsening heart failure in the spironolactone comparison



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03048825


Contacts
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Contact: Melissa McClelland 9055274322 ext 41079 clear@phri.ca
Contact: Jessica Tyrwhitt 9055274322 clear@phri.ca

Locations
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Canada, Ontario
Hamilton General Hospital Recruiting
Hamilton, Ontario, Canada, L8L2X2
Contact: CLEAR Investigator    9055274322    clear@phri.ca   
Sponsors and Collaborators
Population Health Research Institute
Canadian Institutes of Health Research (CIHR)
BSC
Investigators
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Principal Investigator: Sanjit S Jolly, MD Population Health Research Institute
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Responsible Party: Population Health Research Institute
ClinicalTrials.gov Identifier: NCT03048825    
Other Study ID Numbers: CLSYN.1702
OASIS-9 ( Other Identifier: Population Health Research Institute )
First Posted: February 9, 2017    Key Record Dates
Last Update Posted: September 16, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Additional relevant MeSH terms:
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Myocardial Infarction
ST Elevation Myocardial Infarction
Non-ST Elevated Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Colchicine
Spironolactone
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents
Gout Suppressants
Antirheumatic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents