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Could a single daily pill slash heart disease risks?

NCT ID NCT06930885

Disease control Sponsor: Hospital do Coracao Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

The EPOCA trial is testing whether a daily 'polypill' (combining blood pressure, cholesterol, and blood-thinning medications) plus the anti-inflammatory drug colchicine can reduce major heart and limb events in people with established heart disease. Over 7,700 participants aged 45 and older with a history of heart attacks, strokes, or artery blockages will be followed for several years. The goal is to see if this simpler, combined approach lowers the risk of cardiovascular death, heart attack, stroke, urgent artery procedures, and leg amputations better than current treatments.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
A combination pill containing valsartan (blood pressure drug), atorvastatin (cholesterol drug), and aspirin (blood thinner), plus the anti-inflammatory drug colchicine.
What this could lead to
If successful, this could provide a simple, once-daily pill regimen that significantly lowers the risk of heart attacks, strokes, and limb amputations in people with established heart disease.
What could go wrong
This is a large Phase 3 trial, but the polypill and colchicine are already approved drugs, so the main question is whether combining them works better than current standard care. Side effects like muscle pain, bleeding, or stomach issues are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 7,713 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2025

Expected to finish

May 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

45 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Individuals aged ≥ 45 years AND * Signature of the Informed Consent Form (ICF) AND at least one of the following criteria: * Previous atherothrombotic cardiovascular event (acute coronary syndrome, ischemic stroke, high-risk transient ischemic stroke, acute limb ischemia/arterial occlusion, or non-traumatic limb amputation) AND/OR * Previous arterial revascularization (percutaneous, surgical, and/or hybrid) OR * Diagnosis of significant atherosclerotic disease with ≥ 50% obstruction in any arterial territory (coronary, cerebrovascular, or peripheral), in the absence of a prior cardiovascular event or arterial revascularization. Exclusion Criteria: * Pregnant or lactating women; * Women of childbearing age who do not use any form of contraception; * Known history of chronic kidney disease, stage ≥ 4 (estimated glomerular filtration rate ≤ 30 mL/min, if available); * Known history of cirrhosis or severe liver disease (e.g., transaminase levels \> 3 times the upper limit of normal, if available); * Known history of inflammatory muscle disease (e.g., dermatomyositis or polymyositis) or creatine phosphokinase (CPK) levels \> 3 times the upper limit of normal, if available); * Known history of moderate or severe valvular heart disease with anticipated need for valvular intervention within the next 12 months; * Planned arterial revascularization (inclusion is possible 30 days after completion of all planned procedures); * Left ventricular ejection fraction ≤40% (with the exception of patients with documented intolerance to ACE inhibitors and/or sacubitril/valsartan, who remain eligible for study enrollment); * Heart failure with functional class ≥ III according to the New York Heart Association (NYHA), regardless of left ventricular ejection fraction; * Blood pressure \< 120/80 mmHg in the absence of antihypertensive therapy; * Life expectancy ≤ 12 months; * Acute arterial event (acute coronary syndrome, non-cardioembolic ischemic stroke, acute limb ischemia) in the past 30 days; * Substance abuse/alcoholism; * Psychiatric and/or neurodegenerative disorder limiting self-care capacity; * Concurrent participation in another randomized clinical trial; * Contraindication to any component of the polypill; * Current or planned use of oral anticoagulant therapy within the next 12 months (except rivaroxaban 2.5 mg twice daily for patients with peripheral artery disease); * High risk of bleeding (e.g., but not limited to: blood dyscrasias, hemophilia, previous gastrointestinal or central nervous system bleeding); * Contraindication to colchicine; * Current use of colchicine.

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Conditions

The condition(s) this trial relates to.

atherosclerosis atherosclerotic cardiovascular disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Atherosclerotic cardiovascular disease (ascvd) Atherothrombotic diseases

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    13 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • CIPES - Centro Internacional de Pesquisa Clínica

    RECRUITING

    São José dos Campos, São Paulo, Brazil

  • CMEP - Centro Multidisciplinar de Ensino especializado e Pesquisa

    RECRUITING

    Joinville, Santa Catarina, Brazil

  • Centro de Pesquisa Cardiolima

    RECRUITING

    Teresina, Piauí, Brazil

    Contact Email: •••••@•••••

  • Centro de Pesquisa Cetrus

    RECRUITING

    São Paulo, São Paulo, Brazil

  • Centro de Pesquisas Clínicas Dr. Marco Mota

    RECRUITING

    Maceió, Alabama, 57051160, Brazil

    Contact Email: •••••@•••••

  • Empresa Brasileira de Serviços Hospitalares - EBSERCH - Hospital de Ensino Dr. Washington Antônio de Barros- HU-UNIVASF

    RECRUITING

    Petrolina, Pernambuco, Brazil

  • Fundação Faculdade Regional de Medicina São José do Rio Preto

    RECRUITING

    São José do Rio Preto, São Paulo, 15.090-000, Brazil

  • Fundação Técnico Educacional Souza Marques

    RECRUITING

    Rio de Janeiro, Rio de Janeiro, 22.793-140, Brazil

  • Fundação Universitária de Cardiologia - ICFUC

    RECRUITING

    Porto Alegre, Rio Grande do Sul, Brazil

    Contact Email: •••••@•••••

  • Hcor

    RECRUITING

    São Paulo, São Paulo, 04004-030, Brazil

  • Hospital Universitário São Francisco na Providência de Deus

    RECRUITING

    Bragança Paulista, São Paulo, Brazil

  • Instituto de Pesquisa e Ensino em Saúde - IPES

    RECRUITING

    Porto Velho, Rondônia, Brazil

  • Secretária da Saúde do Estado do Ceará - Hospital de Messejana Dr. Carlos Alberto Studart Gomes

    RECRUITING

    Messejana, Ceará, Brazil

    Contact Email: •••••@•••••

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