RecruitingPhase 3NCT05633810

COLchicine and Non-enteric Coated Aspirin in the Cardiovascular Outcomes Trial of Patients With Type 2 Diabetes

COLchicine and Non-enteric Coated Aspirin in the Cardiovascular Outcomes Trial of Patients With Type 2 Diabetes (COLCOT-T2D)

Sponsor

Montreal Heart Institute

Enrollment

10,000 participants

Start Date

Dec 21, 2022

Study Type

INTERVENTIONAL

Conditions

Cardiovascular Diseases Diabete Type 2

Summary

To evaluate the efficacy and safety of colchicine and non-enteric coated aspirin, combined or alone, to improve cardiovascular outcomes in high-risk patients with type 2 diabetes.

Eligibility

Min Age: 55 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether colchicine (an anti-inflammatory medicine) and low-dose aspirin can help prevent heart attacks and strokes in people with type 2 diabetes who have never had a heart event. You may be eligible if: - You are a man or woman between 55 and 80 years old - You have type 2 diabetes managed according to standard care - You have never had a heart attack, chest pain (angina), or heart procedure - You have at least one additional risk factor, such as: long-standing diabetes (5+ years), high HbA1c, active smoking, high inflammation markers, high calcium score in your heart arteries, high triglycerides, high LDL cholesterol, low HDL cholesterol, high Lp(a), blood vessel disease in the legs or brain, diabetic eye or nerve damage, or protein in your urine You may NOT be eligible if: - You have had a heart attack, stroke, chest pain, or heart procedure in the past - You have significant kidney problems (low kidney function) - You have had cancer in the last 3 years (certain minor skin cancers may be okay) - You have inflammatory bowel disease, chronic diarrhea, or a stomach ulcer in the last 2 years - You have significant muscle disease, low blood counts, or abnormal liver tests - You are pregnant, breastfeeding, or planning to become pregnant during the study - You are currently taking aspirin, a blood thinner, colchicine, or an anti-inflammatory medicine regularly - You have a known allergy to aspirin or colchicine Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAspirin

40 mg non-enteric-coated tablet taken twice daily.

DRUGAspirin Placebo

non-enteric-coated tablet taken twice daily.

DRUGColchicine

0.5 mg tablet taken once daily

DRUGColchicine Placebo

tablet taken once daily.

Locations(39)

Curtin University

Bentley, Western Australia, Australia

St. Michael's Hospital

Toronto, Ontario, Canada

Montreal Heart Institute

Montreal, Quebec, Canada

Center for Translational Cardiology and Pragmatic Randomized Trial

Hellerup, Denmark

Heart and Lung Center, Helsinki University Hospital and Helsinki University

Helsinki, Finland

Maison de Santé du Sud Ruthénois

Luc-la-Primaube, Aveyron, France

MSP Ty santé Vannes Tohannic

Vannes, Brittany Region, France

Maison de Santé Pluriprofessionnelle OLEA

Bezouce, Gard, France

MSPU la Source

Vergèze, Gard, France

MSPU Pins Justaret

Pins-Justaret, Haute-Garonne, France

Pôle de Santé et Prevention du Clion

Pornic, Loire Atlantiue, France

CHU de Poitiers

Poitiers, New Aquitaine, France

Centre Medical Villa Ravas

Montpellier, Occitanie, France

CHU de Montpellier

Montpellier, Occitanie, France

CHU de Toulouse

Toulouse, Occitanie, France

Centre de santé Kersanté Toulouse La Terrasse

Toulouse, Occitanie, France

Maison de Santé Pluriprofessionnelle Universitaire LA PROVIDENCE

Toulouse, Occitanie, France

CHU de Nîmes

Nîmes, Occtanie, France

CHU de Nantes

Nantes, Pays de la Loire Region, France

MSP Noirmoitier

Noirmoutier-en-l'Île, Pays de la Loire Region, France

CMS Salvador Allende

La Courneuve, Seine-Saint-Denis, France

MSPU la collégiale

Poissy, Yvelines, France

Cabinet médical Les Oiseaux

Morsang-sur-Orge, France

Centre de santé Kersanté Rosa Parks

Paris, France

Evgenidion Clinic "Agia Trias" S.A.

Athens, Greece

Policlinico Riuniti U.O. Di Diabetologia

Foggia, Apulia, Italy

Ospedale Miulli U.O.C. Endocrinologia

Acquaviva delle Fonti, Bari, Italy

Dipartimento Cure Primarie Diabetologia Territoriale

Ferrara, Emilia-Romagna, Italy

Ospedale Civile Santa Maria Delle Croci U.O. Diabetologia

Ravenna, Emilia-Romagna, Italy

Adiabetologiasst Ospedale Metropolitano Niguarda

Milan, Lombardy, Italy

"Ospedale Oftalmico S.C. Endocrinologia E Metaboliche"

Turin, Piedmont, Italy

Ospedali Riuniti Clinica Di Cardiologia E Aritmologia

Ancona, The Marches, Italy

Ospedale San Giovanni Di Dio, U.O. Diabetologia E Malatt. Metaboliche

Florence, Tuscany, Italy

Ftgm - Stabilimento Di Pisa Uos Vd Attivita Ambulatoriali E Ospedale Diurno

Pisa, Tuscany, Italy

Ospedale San Jacopo Sezione Di Diabetologia

Pistoia, Tuscany, Italy

Ospedale A. Cardarelli Sc Diabetologia Ed Endocrinologia

Campobasso, Italy

Unidade de Saúde Local Amadora-Sintra

Amadora, Portugal

Hospital de Luz Lisboa

Lisbon, Portugal

Unidade Local de Saue Santa Maria, EPE

Lisbon, Portugal

View Full Details on ClinicalTrials.gov

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NCT05633810

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