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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

Tracking Information
First Submitted Date  ICMJE February 3, 2017
First Posted Date  ICMJE February 9, 2017
Last Update Posted Date April 19, 2019
Actual Study Start Date  ICMJE February 1, 2018
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 7, 2017)
  • 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
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03048825 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Colchicine and Spironolactone in Patients With STEMI / SYNERGY Stent Registry
Official Title  ICMJE 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)
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).
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE 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
Condition  ICMJE ST Elevation Myocardial Infarction
Intervention  ICMJE
  • 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.
  • Drug: Colchicine-Placebo
    Matching Colchicine-placebo twice daily
  • Drug: Spironolactone-Placebo
    Matching Spironolactone-Placebo once daily
Study Arms  ICMJE
  • 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.

    Interventions:
    • Drug: Colchicine
    • Drug: Spironolactone
    • Device: SYNERGY Bioabsorbable Polymer Drug-Eluting Stent
  • 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.

    Interventions:
    • Drug: Spironolactone
    • Device: SYNERGY Bioabsorbable Polymer Drug-Eluting Stent
    • Drug: Colchicine-Placebo
  • 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.

    Interventions:
    • Drug: Colchicine
    • Device: SYNERGY Bioabsorbable Polymer Drug-Eluting Stent
    • Drug: Spironolactone-Placebo
  • 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.

    Interventions:
    • Device: SYNERGY Bioabsorbable Polymer Drug-Eluting Stent
    • Drug: Colchicine-Placebo
    • Drug: Spironolactone-Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 7, 2017)
4000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2021
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Christopher Zapallow, MSc 9055274322 ext 40513 clear@phri.ca
Contact: Brandi Meeks, MSc 9055274322 clear@phri.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03048825
Other Study ID Numbers  ICMJE CLSYN.1702
OASIS-9 ( Other Identifier: Population Health Research Institute )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Population Health Research Institute
Study Sponsor  ICMJE Population Health Research Institute
Collaborators  ICMJE
  • Canadian Institutes of Health Research (CIHR)
  • Boston Scientific Corporation
Investigators  ICMJE
Principal Investigator: Sanjit S Jolly, MD Population Health Research Institute
PRS Account Population Health Research Institute
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP