Atherothrombotic DiseasesPhase 3EPOCANCT06930885
Polypill and Colchicine for Risk Reduction in Atherosclerotic Cardiovascular Disease
A Phase 3 study testing Cardiovascular Polypill (Valsartan, Atorvastatin, Aspirin) and Colchicine 0.5 mg in people with Atherothrombotic Diseases and Atherosclerotic Cardiovascular Disease (ASCVD), run by Hospital do Coracao at 13 sites in Brazil.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Atherothrombotic Diseases, Atherosclerotic Cardiovascular Disease (ASCVD)
- What is being tested?
- Cardiovascular Polypill (Valsartan, Atorvastatin, Aspirin) and Colchicine 0.5 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7,713 participants
- Where
- 13 sitesBrazil
- Study dates
- 12 Jun 2025to May 2031
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
13 sites in 1 country
Brazil13 sites, 13 recruiting
- Recruiting
Hospital Universitário São Francisco na Providência de Deus
Bragança Paulista, São Paulo
Murillo de Oliveira Antunes, +55 11 2490 1366, cepec.husf@alsf.org.br
- Recruiting
CMEP - Centro Multidisciplinar de Ensino especializado e Pesquisa
Joinville, Santa Catarina
Conrado Roberto Hoffmann Filho, +55 47 9220 6886, pesquisa3@pesquisacmep.com.br
- Recruiting
Centro de Pesquisas Clínicas Dr. Marco Mota
Maceió, Alabama, 57051160
Marco Mota, Principal Investigator, +55 82 3215-5032, centrodepesquisasclinicas@cesmac.edu.br
- Recruiting
Secretária da Saúde do Estado do Ceará - Hospital de Messejana Dr. Carlos Alberto Studart Gomes
Messejana, Ceará
João David de Souza Neto, Principal Investigator, +55 85 399810 6905, unidadepesquisaclinica@gmail.com
- Recruiting
Empresa Brasileira de Serviços Hospitalares - EBSERCH - Hospital de Ensino Dr. Washington Antônio de Barros- HU-UNIVASF
Petrolina, Pernambuco
Polyana Evangelista Lima, Principal Investigator, +55 87 2101 6504, ancianato@portalbethesda.org.br
- Recruiting
Fundação Universitária de Cardiologia - ICFUC
Porto Alegre, Rio Grande do Sul
Maico Furlanetto, Principal Investigator, +55 51 3230 3860, pesquisaclinica@cardiologia.org.br
- Recruiting
Instituto de Pesquisa e Ensino em Saúde - IPES
Porto Velho, Rondônia
Marcus Vinicius Nunes Batista, +55 69 9378 7257, ipesrondonia@gmail.com
- Recruiting
Fundação Técnico Educacional Souza Marques
Rio de Janeiro, Rio de Janeiro, 22.793-140
Fabio Akio Nishijuka, Principal Investigator, +55 21 2128-4900, cepmsm@souzamarques.br
- Recruiting
Fundação Faculdade Regional de Medicina São José do Rio Preto
São José do Rio Preto, São Paulo, 15.090-000
Marcelo Arruda Nakazone, Principal Investigator, +55 17 3201-5054, coordenação.cardio@centrodepesquisacip.com.br
- Recruiting
CIPES - Centro Internacional de Pesquisa Clínica
São José dos Campos, São Paulo
Fabiana Marcondes, Principal Investigator, +55 12 99726 2171, contato@cipes.com.br
- Recruiting
Hcor
São Paulo, São Paulo, 04004-030
Lucas Tramujas, Principal Investigator, +55 11 96910-7556, ltramujas@hcor.com.br
- Recruiting
Centro de Pesquisa Cetrus
São Paulo, São Paulo
Pablo de Oliveira Antunes, +55 11 91513 0651, pesquisa@cetrus.com.br
- Recruiting
Centro de Pesquisa Cardiolima
Teresina, Piauí
Carlos Eduardo Batista Lima, +55 86 3085 3048, admin@cardiolima.com.br
About this study
Official title: Evaluation of a POlypill and Colchicine for Risk Reduction in Patients With Established Atherosclerotic Cardiovascular Disease: The EPOCA Randomized Clinical Trial
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.
Read the detailed description
Cardiovascular disease is the leading cause of morbidity and mortality worldwide and in Brazil. Additionally, cardiovascular risk factors are highly prevalent conditions which are, frequently, present in association. Despite the last therapeutic advances, rates of adequate control of these conditions are still low. One proposed strategy to increase such control and decrease cardiovascular risk is the use of fixed-dose combinations of different pharmacological classes, to be taken on single daily dose - a polypill. This strategy has already been studied in other parts of the world, especially in patients with established or at risk for coronary heart disease (CHD).
Furthermore, there has been a need to explore other therapeutic targets beyond traditional risk factors that could impact the process of atherosclerosis. Among the various options evaluated, colchicine has emerged as a viable alternative, given its clinical use experience, mechanism of action, and the results showing a reduction in inflammatory biomarkers as well as clinical outcomes in individuals with different manifestations of coronary artery disease. However, it is important to highlight some key points regarding the available studies evaluating both the treatment strategy based on a polypill and the use of colchicine in the context of atherosclerotic cardiovascular disease (ASCVD).
The studies supporting both approaches were primarily conducted with participants with coronary artery disease from centers in Europe, the U.S., Iran, Oceania, and India, and there is a lack of robust evidence regarding these therapeutic strategies in other countries with a diverse population like Brazil, as well as in individuals with other manifestations of ASCVD (including peripheral arterial disease and cerebrovascular disease).
Given high prevalence of atherosclerotic cardiovascular disease and its traditional risk factors, low control rates, high levels of poor adherence and therapeutic inertia, and the specific realities of the population and healthcare system, evaluating the efficacy of a polypill strategy (fixed-dose an antihypertensive, aspirin, and high-potency statin) with a single daily dose, along with colchicine, in preventing cardiovascular events could contribute to improving cardiovascular care.
- Being tested
- Cardiovascular Polypill (Valsartan, Atorvastatin, Aspirin), Colchicine 0.5 mg, Usual Care Group, Colchicine-placebo 0.5 mg
- Keywords
- Atherothrombotic diseases, Atherosclerotic cardiovascular disease, Polypill, Colchicine
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiovascular Polypill (Valsartan, Atorvastatin, Aspirin)Drug
Cardiovascular Polypill contains Valsartan, Atorvastatin, Aspirin
- Valsartan 160 mg + Atorvastatin 40 mg + Aspirin 100 mg or
- Valsartan 160 mg + Atorvastatin 80 mg + Aspirin 100 mg or
- Valsartan 320 mg + Atorvastatin 40 mg + Aspirin 100 mg or
- Valsartan 320 mg + Atorvastatin 80 mg + Aspirin100 mg or
- Valsartan 80 mg + Atorvastatin 40 mg + Aspirin 100 mg or
- Valsartan 80 mg + Atorvastatin 80 mg + Aspirin 100 mg or
- Valsartan 80 mg + Atorvastatin 20 mg + Aspirin 100 mg* or
- Valsartan 160 mg + Atorvastatin 20 mg + Aspirin 100 mg* or
- Valsartan 320 mg + Atorvastatin 20 mg + Aspirin 100 mg*
- The use of these formulations of the cardiovascular polypill will be restricted to cases of Statin-Related Muscle Symptoms (SRMS)
Colchicine 0.5 mgDrug
Colchicine 0.5 mg once daily
Usual Care GroupDrug
Patients allocated to the usual care arm will receive standard of care therapies for secondary prevention according to the guidelines. Drugs and doses will be left at the discretion of the treating physicians.
Colchicine-placebo 0.5 mgDrug
Matching Colchicine-placebo 0.5 mg once daily
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Cardiovascular Polypill + Colchicine 0.5 mg once daily Receives: Drug: Cardiovascular Polypill (Valsartan, Atorvastatin, Aspirin); Drug: Colchicine 0.5 mg |
| Group 2 | Experimental | Cardiovascular Polypill + Colchicine placebo 0.5 mg once daily Receives: Drug: Cardiovascular Polypill (Valsartan, Atorvastatin, Aspirin); Drug: Colchicine-placebo 0.5 mg |
| Group 3 | Experimental | Usual care + Colchicine 0.5 mg once daily Receives: Drug: Colchicine 0.5 mg; Drug: Usual Care Group |
| Group 4 | Experimental | Usual care + Colchicine placebo 0.5 mg once daily Receives: Drug: Usual Care Group; Drug: Colchicine-placebo 0.5 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary efficacy endpoint: Major adverse cardiovascular and limb events (MACLE)
Time to cardiovascular death, non-fatal type 1 myocardial infarction, non-fatal ischemic stroke, urgent arterial revascularization, and non-traumatic major lower limb amputation
Measured: Through study completion, an estimated average of 3 years
Secondary outcomes (4)
Key secondary endpoint: Major adverse cardiovascular events (MACE)
Time to cardiovascular mortality, non-fatal type 1 myocardial infarction, and non-fatal ischemic stroke.
Measured: Through study completion, an estimated average of 3 years
Cardiovascular death
Time to cardiovascular death
Measured: Through study completion, an estimated average of 3 years
Non-fatal type 1 myocardial infarction
Time to non-fatal type 1 myocardial infarction
Measured: Through study completion, an estimated average of 3 years
Non-fatal ischemic stroke
Time to non-fatal ischemic stroke
Measured: Through study completion, an estimated average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2025
- Study start12 Jun 2025
- Primary completionMay 2031 (estimated)
- Study completionMay 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Atherothrombotic DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- They will be randomized, simultaneously, in a 1:1:1:1 ratio to polypill or usual care, and colchicine 0.5 mg once daily versus placebo, in a 2x2 factorial design. Therefore, the study will have four possible groups: Cardiovascular polypill + colchicine 0.5 mg once daily; Cardiovascular polypill + Colchicine placebo once daily; Usual care + Colchicine 0.5 mg once daily; or Usual care + Colchicine placebo once daily.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 7,713 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital do Coracao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pedro Gabriel Melo de Barros e Silva, P.h.D, Study chair, Hcor Research InstituteLucas tramujas, M.D, Principal investigator, Hcor Research InstituteErlon Oliveira de Abreu-Silva, M.D, Principal investigator, Hcor Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06930885
- Sponsor's protocol ID
- EPOCA TRIAL
- Acronym
- EPOCA
- Status last verified
- Apr 2025
- First submitted
- 9 Apr 2025
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Our data dissemination plan will follow the rules of the Hcor research institute
Publications
Tramujas L, Nogueira A, Felix N, Maia I, de Barros E Silva PGM, Cavalcanti AB, Abizaid A. Trends in colchicine use across the spectrum of coronary artery disease. Vascul Pharmacol. 2025 Jun;159:107502. doi: 10.1016/j.vph.2025.107502. Epub 2025 May 13. No abstract available.
PubMed 40373935de Barros E Silva PGM, do Nascimento CT, Pedrosa RP, Nakazone MA, do Nascimento MU, de Araujo Melo L, Junior OLS, Zimmermann SL, de Melo RMV, Bergo RR, Precoma DB, Tramujas L, Lima EG, Dantas JMM, do Amaral Baruzzi AC, Flumignan RLG, de Oliveira Paiva MSM, Gowdak LHW, de Carvalho PN, de Figueiredo Neto JA, Silvestre OM, Fioranelli A, Vieira RD', Horak ACP, Miyada DHK, Kojima FCS, de Oliveira JS, de Oliveira Silva L, Pavanello R, Ramacciotti E, Lopes RD; NEAT Investigators. Primary results of the brazilian registry of atherothrombotic disease (NEAT). Sci Rep. 2024 Feb 20;14(1):4222. doi: 10.1038/s41598-024-54516-9.
PubMed 38378735de Abreu-Silva EO, Siepmann M, Siepmann T. Polypills in the Management of Cardiovascular Risk-A Perspective. J Clin Med. 2024 Sep 16;13(18):5487. doi: 10.3390/jcm13185487.
PubMed 39336974Tramujas L, Nogueira A, Felix N, de Barros E Silva PGM, Abizaid A, Cavalcanti AB. Association of colchicine use with cardiovascular and limb events in peripheral artery disease: Insights from a retrospective cohort study. Atherosclerosis. 2024 Nov;398:118563. doi: 10.1016/j.atherosclerosis.2024.118563. Epub 2024 Aug 9.
PubMed 39299823
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a POlypill and Colchicine for Risk Reduction in Patients With Established Atherosclerotic Cardiovascular Disease: The EPOCA Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06930885
- Acronym / sponsor ID
- EPOCA / EPOCA TRIAL
- Keywords
- Atherothrombotic diseases, Atherosclerotic cardiovascular disease, Polypill, Colchicine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 7,713 participants (estimated)
- Lead sponsor
- Hospital do CoracaoUniversity, hospital or other
- Study start
- 12 Jun 2025 (actual)
- Primary completion
- May 2031 (estimated)
- Study completion
- May 2031 (estimated)
- First posted
- 16 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Cardiovascular disease is the leading cause of morbidity and mortality worldwide and in Brazil. Additionally, cardiovascular risk factors are highly prevalent conditions which are, frequently, present in association. Despite the last therapeutic advances, rates of adequate control of these conditions are still low. One proposed strategy to increase such control and decrease cardiovascular risk is the use of fixed-dose combinations of different pharmacological classes, to be taken on single daily dose - a polypill. This strategy has already been studied in other parts of the world, especially in patients with established or at risk for coronary heart disease (CHD).
Furthermore, there has been a need to explore other therapeutic targets beyond traditional risk factors that could impact the process of atherosclerosis. Among the various options evaluated, colchicine has emerged as a viable alternative, given its clinical use experience, mechanism of action, and the results showing a reduction in inflammatory biomarkers as well as clinical outcomes in individuals with different manifestations of coronary artery disease. However, it is important to highlight some key points regarding the available studies evaluating both the treatment strategy based on a polypill and the use of colchicine in the context of atherosclerotic cardiovascular disease (ASCVD).
The studies supporting both approaches were primarily conducted with participants with coronary artery disease from centers in Europe, the U.S., Iran, Oceania, and India, and there is a lack of robust evidence regarding these therapeutic strategies in other countries with a diverse population like Brazil, as well as in individuals with other manifestations of ASCVD (including peripheral arterial disease and cerebrovascular disease).
Given high prevalence of atherosclerotic cardiovascular disease and its traditional risk factors, low control rates, high levels of poor adherence and therapeutic inertia, and the specific realities of the population and healthcare system, evaluating the efficacy of a polypill strategy (fixed-dose an antihypertensive, aspirin, and high-potency statin) with a single daily dose, along with colchicine, in preventing cardiovascular events could contribute to improving cardiovascular care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- They will be randomized, simultaneously, in a 1:1:1:1 ratio to polypill or usual care, and colchicine 0.5 mg once daily versus placebo, in a 2x2 factorial design. Therefore, the study will have four possible groups: Cardiovascular polypill + colchicine 0.5 mg once daily; Cardiovascular polypill + Colchicine placebo once daily; Usual care + Colchicine 0.5 mg once daily; or Usual care + Colchicine placebo once daily.
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: Cardiovascular Polypill (Valsartan, Atorvastatin, Aspirin), Drug: Colchicine 0.5 mgCardiovascular Polypill + Colchicine 0.5 mg once daily |
| Group 2 | Experimental | Drug: Cardiovascular Polypill (Valsartan, Atorvastatin, Aspirin), Drug: Colchicine-placebo 0.5 mgCardiovascular Polypill + Colchicine placebo 0.5 mg once daily |
| Group 3 | Experimental | Drug: Colchicine 0.5 mg, Drug: Usual Care GroupUsual care + Colchicine 0.5 mg once daily |
| Group 4 | Experimental | Drug: Usual Care Group, Drug: Colchicine-placebo 0.5 mgUsual care + Colchicine placebo 0.5 mg once daily |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (20 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiovascular Polypill (Valsartan, Atorvastatin, Aspirin)Cardiovascular Polypill contains Valsartan, Atorvastatin, Aspirin 1. Valsartan 160 mg + Atorvastatin 40 mg + Aspirin 100 mg or 2. Valsartan 160 mg + Atorvastatin 80 mg + Aspirin 100 mg or 3. Valsartan 320 mg + Atorvastatin 40 mg + Aspirin 100 mg or 4. Valsartan 320 mg + Atorvastatin 80 mg + Aspirin100 mg or 5. Valsartan 80 mg + Atorvastatin 40 mg + Aspirin 100 mg or 6. Valsartan 80 mg + Atorvastatin 80 mg + Aspirin 100 mg or 7. Valsartan 80 mg + Atorvastatin 20 mg + Aspirin 100 mg* or 8. Valsartan 160 mg + Atorvastatin 20 mg + Aspirin 100 mg* or 9. Valsartan 320 mg + Atorvastatin 20 mg + Aspirin 100 mg* * The use of these formulations of the cardiovascular polypill will be restricted to cases of Statin-Related Muscle Symptoms (SRMS) | Drug | Group 1, Group 2 |
| Colchicine 0.5 mgColchicine 0.5 mg once daily | Drug | Group 1, Group 3 |
| Usual Care GroupPatients allocated to the usual care arm will receive standard of care therapies for secondary prevention according to the guidelines. Drugs and doses will be left at the discretion of the treating physicians. | Drug | Group 3, Group 4 |
| Colchicine-placebo 0.5 mgMatching Colchicine-placebo 0.5 mg once daily | Drug | Group 2, Group 4 |
Primary outcome
Primary efficacy endpoint: Major adverse cardiovascular and limb events (MACLE)
Time frame: Through study completion, an estimated average of 3 years
Time to cardiovascular death, non-fatal type 1 myocardial infarction, non-fatal ischemic stroke, urgent arterial revascularization, and non-traumatic major lower limb amputation
4 secondary outcomes
Key secondary endpoint: Major adverse cardiovascular events (MACE)
Time frame: Through study completion, an estimated average of 3 years
Cardiovascular death
Time frame: Through study completion, an estimated average of 3 years
Non-fatal type 1 myocardial infarction
Time frame: Through study completion, an estimated average of 3 years
Non-fatal ischemic stroke
Time frame: Through study completion, an estimated average of 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Background: PubMed 40373935Tramujas L, Nogueira A, Felix N, Maia I, de Barros E Silva PGM, Cavalcanti AB, Abizaid A. Trends in colchicine use across the spectrum of coronary artery disease. Vascul Pharmacol. 2025 Jun;159:107502. doi: 10.1016/j.vph.2025.107502. Epub 2025 May 13. No abstract available.
- Background: PubMed 38378735de Barros E Silva PGM, do Nascimento CT, Pedrosa RP, Nakazone MA, do Nascimento MU, de Araujo Melo L, Junior OLS, Zimmermann SL, de Melo RMV, Bergo RR, Precoma DB, Tramujas L, Lima EG, Dantas JMM, do Amaral Baruzzi AC, Flumignan RLG, de Oliveira Paiva MSM, Gowdak LHW, de Carvalho PN, de Figueiredo Neto JA, Silvestre OM, Fioranelli A, Vieira RD', Horak ACP, Miyada DHK, Kojima FCS, de Oliveira JS, de Oliveira Silva L, Pavanello R, Ramacciotti E, Lopes RD; NEAT Investigators. Primary results of the brazilian registry of atherothrombotic disease (NEAT). Sci Rep. 2024 Feb 20;14(1):4222. doi: 10.1038/s41598-024-54516-9.
- Background: PubMed 39336974de Abreu-Silva EO, Siepmann M, Siepmann T. Polypills in the Management of Cardiovascular Risk-A Perspective. J Clin Med. 2024 Sep 16;13(18):5487. doi: 10.3390/jcm13185487.
- Background: PubMed 39299823Tramujas L, Nogueira A, Felix N, de Barros E Silva PGM, Abizaid A, Cavalcanti AB. Association of colchicine use with cardiovascular and limb events in peripheral artery disease: Insights from a retrospective cohort study. Atherosclerosis. 2024 Nov;398:118563. doi: 10.1016/j.atherosclerosis.2024.118563. Epub 2024 Aug 9.
- Individual participant dataSharing planned: Yes. Our data dissemination plan will follow the rules of the Hcor research institute
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Centro de Pesquisas Clínicas Dr. Marco Mota
Maceió, Brazil
Secretária da Saúde do Estado do Ceará - Hospital de Messejana Dr. Carlos Alberto Studart Gomes
Messejana, Brazil
Empresa Brasileira de Serviços Hospitalares - EBSERCH - Hospital de Ensino Dr. Washington Antônio de Barros- HU-UNIVASF
Petrolina, Brazil
Pedro Gabriel Melo de Barros e Silva, P.h.D study chair
Hcor Research Institute
Lucas tramujas, M.D principal investigator
Hcor Research Institute
Erlon Oliveira de Abreu-Silva, M.D principal investigator
Hcor Research Institute
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cardiovascular Polypill (Valsartan, Atorvastatin, Aspirin) and Colchicine 0.5 mg in people with Atherothrombotic Diseases and Atherosclerotic Cardiovascular Disease (ASCVD), run by Hospital do Coracao at 13 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary efficacy endpoint: Major adverse cardiovascular and limb events (MACLE) (time frame: Through study completion, an estimated average of 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06930885, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.