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New treatment option for Atherothrombotic Diseases
Official title Polypill and Colchicine for Risk Reduction in Atherosclerotic Cardiovascular Disease
ClinicalTrials.gov ID: NCT06930885
What this study is testing
What is Cardiovascular Polypill (Valsartan, Atorvastatin, Aspirin)?
Cardiovascular Polypill (Valsartan, Atorvastatin, Aspirin) is an investigational medicine, given as an once-daily, being studied as a potential treatment for atherothrombotic diseases.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 and older
You may be able to join if
- 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...
- 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...
You likely can't join if
- 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...
- Known history of moderate or severe valvular heart disease with anticipated need for valvular intervention within the next 12 months;
See the full eligibility 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.
- 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 assigned by chance 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.
The study team makes the final eligibility decision.
Where it's taking place
- Maceió, Alabama, Brazil
- Messejana, Ceará, Brazil
- Petrolina, Pernambuco, Brazil
- Teresina, Piauí, Brazil
- Rio de Janeiro, Rio de Janeiro, Brazil
- Porto Alegre, Rio Grande do Sul, Brazil
- Porto Velho, Rondônia, Brazil
- Joinville, Santa Catarina, Brazil
- Bragança Paulista, São Paulo, Brazil
- São José do Rio Preto, São Paulo, Brazil
- São José dos Campos, São Paulo, Brazil
- São Paulo, São Paulo, Brazil
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 45 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Maceió, Alabama, Brazil; Messejana, Ceará, Brazil; Petrolina, Pernambuco, Brazil; Teresina, Piauí, Brazil; Rio de Janeiro, Rio de Janeiro, Brazil; Porto Alegre, Rio Grande do Sul, Brazil and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.