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

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ClinicalTrials.gov Identifier: NCT03048825
Recruitment Status : Recruiting
First Posted : February 9, 2017
Last Update Posted : April 19, 2019
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Boston Scientific Corporation
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 ST elevation 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 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 ST-elevation myocardial infarction who have undergone primary percutaneous coronary intervention (PCI).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4000 participants
Allocation: Randomized
Intervention Model: Parallel 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 ST-elevation Myocardial Infarction (STEMI) / SYNERGY Stent Registry - CLEAR-SYNERGY (OASIS-9)
Actual Study Start Date : February 1, 2018
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : December 30, 2021

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



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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. Patients with STEMI referred for PCI within 12 hours of symptom onset, and have culprit lesion amenable to stenting (after the initial 800 patients received SYNERGY stent [SYNERGY Stent phase], patients will be eligible if referred within 24 hours of symptom onset)

    (All patients participating in the drug portion are required to be randomized within 24 hours of index PCI and during initial hospitalization)

  2. Written informed consent

Exclusion Criteria:

  1. Known allergy or contraindication to everolimus, the SYNERGY stent or any of its components
  2. Unable to receive dual antiplatelet therapy
  3. Age ≤18 years
  4. Pregnancy, breastfeeding, or women of childbearing potential who are not using an effective method of contraception
  5. Any contraindication or known intolerance to colchicine or spironolactone
  6. Requirement for colchicine or spironolactone for another indication
  7. Creatinine clearance <30 mL/min/1.73 m^2
  8. History of cirrhosis or current severe hepatic disease
  9. Systolic blood pressure <90 mm Hg
  10. Serum Potassium >5.0 meq/L
  11. Current or planned use of HIV protease inhibitors, azole antifungals, or macrolide antibiotics
  12. Active diarrhea
  13. Any medical, geographic, or social factor making study participation impractical or precluding follow-up

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: Christopher Zapallow, MSc 9055274322 ext 40513 clear@phri.ca
Contact: Brandi Meeks, MSc 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)
Boston Scientific Corporation
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     History of Changes
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: April 19, 2019
Last Verified: April 2019
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
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Myocardial Infarction
ST Elevation 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