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Colchicine and Spironolactone in Patients with MI / SYNERGY Stent Registry

NCT03048825 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 7264

Last updated 2024-10-15

No results posted yet for this study

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).

Conditions

  • ST Elevation Myocardial Infarction
  • Non ST Elevation Myocardial Infarction

Interventions

DRUG

Colchicine

Colchicine 0.5 mg once 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 once daily

DRUG

Spironolactone-Placebo

Matching Spironolactone-Placebo once daily

Sponsors & Collaborators

  • Boston Scientific Corporation

    collaborator INDUSTRY

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • Population Health Research Institute

    lead OTHER

Principal Investigators

  • Sanjit S Jolly, MD · Population Health Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-01
Primary Completion
2024-08-09
Completion
2024-08-09
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States
  • Australia
  • Canada
  • Czechia
  • Egypt
  • France
  • Hungary
  • Nepal
  • Netherlands
  • North Macedonia
  • Serbia
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03048825 on ClinicalTrials.gov