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Polypill and Colchicine for Risk Reduction in Atherosclerotic Cardiovascular Disease

Study acronym: EPOCA
StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Study sites: 6 to 13
    • Eligibility criteria expanded, about 30 words
    v3
  2. Trial status: Not Yet Recruiting to Recruitingv2 Show 7 more changesShow less
    • Study sites: 0 to 6
    • Start date changed from estimate of May 2025 to Jun 12, 2025
    • Interventions: Cardiovascular Polypill (Drug), Colchicine 0.5 mg (Drug), Colchicine-placebo 0.5 mg (Drug), Usual Care Group (Drug) to Cardiovascular Polypill (Valsartan, Atorvastatin, Aspirin) (Drug), Colchicine 0.5 mg (Drug), Colchicine-placebo 0.5 mg (Drug), Usual Care…
    • Eligibility criteria expanded, about 28 words
    • Publications: 3 to 4
    • Study title shortened, about 6 words
    • Study description expanded, about 4 words
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The EPOCA study (Evaluation of a POlypill and Colchicine for risk reduction in patients with established Atherosclerotic cardiovascular disease) will be a randomized, superiority, parallel, 2x2 factorial, multicenter clinical trial which will include at least 7713 and up to a maximum of 10797 participants with established atherosclerotic cardiovascular disease.
Trial Details
NCT Number NCT06930885
Lead Sponsor Hospital do Coracao
Conditions
(from sponsor)		 Atherothrombotic Diseases, Atherosclerotic Cardiovascular Disease (ASCVD)
Related terms Atherosclerosis
Enrollment 7,713 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov