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Studies

Interventional Recruiting Phase 3

NCT05633810 on ClinicalTrials.gov

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

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

  • Sponsor: Montreal Heart Institute
  • Enrollment: 10000 (Estimated)
  • Study start: 2022-12-21 (Actual)
  • Primary completion: 2027-12-01 (Estimated)
  • Study completion: 2027-12-01 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Factorial
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • PrimaryPurpose: Prevention

Brief 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.

Conditions

  • Diabete Type 2
  • Cardiovascular Diseases

Intervention / Treatment

  • Drug: Aspirin
  • Drug: Aspirin
  • Drug: Aspirin Placebo
  • Drug: Aspirin Placebo
  • Drug: Colchicine
  • Drug: Colchicine
  • Drug: Colchicine Placebo
  • Drug: Colchicine Placebo

Primary Outcome Measures

  • First event of the composite of cardiovascular death, resuscitated cardiac arrest, non-fatal myocardial infarction, non-fatal stroke, or urgent hospitalization for angina requiring coronary revascularization. (From randomization to occurrence of first event, assessed up to 60 months.)
    The number of participants having at least one of the composite of the primary endpoint.

Countries

Australia, Canada, Denmark, Finland, France, Greece, Italy, Portugal

Locations and Investigators

  • Evgenidion Clinic Agia Trias S.A., Athens, Greece
    • Spyridon, Deftereos
  • Hospital Da Luz S.A., Lisbon, Portugal
    • Anabela, Raimundo
  • Unidade Local De Saude De Amadora Sintra E.P.E., Amadora, Portugal
    • Sérgio, Baptista
  • Unidade Local De Saude De Santa Maria E.P.E., Lisbon, Portugal
  • Centre Hospitalier De Carcassonne, Carcassonne, France
    • Samia, BENALI
  • Centre Hospitalier De Beziers, Beziers, France
    • Frédéric, Georger
  • Maison de Santé Pluriprofessionnelle OLEA, Bezouces, France
    • Aurélie, URENA DORES
  • Centre Hospitalier Universitaire De Nimes, Nimes Cedex 9, France
    • Guillaume, Cayla
  • Maison de santé - Au Fil de l'Eau., Pantin, France
    • Auriane, Cabannes
  • Association Des Professionnels De Sante De Pontgibaud Sioule Et Volcans, Pontgibaud, France
    • Thibault, Menini
  • Maison de Santé La Collégiale, Poissy, France
    • Oliver, Saint-Lary
  • Cabinet Médical les Oiseaux, Morsang-sur-Orge, France
    • Alexandre, Malmartel
  • De Joze SISA, Joze, France
    • Elodie, Charuel
  • Association Pour Le Developpement Des Centres De Sante - Kersanté, Paris 19, France
    • Laurence, MARRIE
  • MSPU Pins Justaret, Pins Justaret, France
    • Julie, DUPOUY
  • Maison de santé Pierre et Marie Curie, Pornic, France
    • Cédric, Rat
  • Clinique Du Pont De Chaume, Montauban, France
    • Laurent, Delorme
  • Centre Hospitalier Universitaire De Nantes, Saint Herblain, France
  • Centre Municipal de Santé - La Courneuve, La Courneuve, France
    • Julien, Le Breton
  • Association Pour Le Developpement Des Centres De Sante, Toulouse, France
    • Pierrik, Fostier
  • Centre Hospitalier Universitaire Grenoble Alpes, Grenoble Cedex 9, France
    • Gilles, BARONE-ROCHETTE
  • MSPU la Source, Vergèze, France
    • Chloé, SIKIRDJI
  • Centre Hospitalier Universitaire De Poitiers, Poitiers, France
    • Claire, Bouleti
  • Cabinet Médical Ty Santé, Vannes, France
    • Charlotte, Grimault
  • Pole De Sante Saint Laurent, Caen, France
    • Xavier, Humbert
  • Centre Hospitalier Universitaire De Montpellier, Montpellier Cedex 5, France
  • Centre Hospitalier De Pau, Pau, France
    • Jean-François, Riviere
  • Maison de Santé Pluridisciplinaire de Ile de Noirmoutier, Barbâtre, France
    • Cyrille, Vartanian
  • Centre Medical Villa Ravas, Montpellier, France
    • Karolina, GRIFFITHS
  • Maison de santé pluriprofessionnelle universitaire Jacques Prévert, Montigny-Le-Bretonneux, France
    • Louise, Devilliers
  • Maison de santé pluriprofessionnel - Luc La Primaube, Luc-La-Primaube, France
    • Denis, Perez
  • Du Pole De Sante Du Port De Granville SISA, Granville, France
    • François, Le Bas
  • Maison de Santé Pluridisciplinaire Universitaire La Providence, Toulouse, France
    • Marie-Eve, Rougé-Bugat
  • Centre Hospitalier Universitaire De Toulouse, Toulouse Cedex 9, France
    • Meyer, Elbaz
  • Azienda Unita Sanitaria Locale Della Romagna, Ravenna, Italy
    • Paolo, Di Bartolo
  • Azienda Ospedaliero Universitaria Delle Marche, Ancona, Italy
    • Giuseppe, Ciliberti
  • Fondazione Toscana Gabriele Monasterio, Pisa, Italy
  • Universita' Degli Studi G. D'Annunzio Di Chieti, Chieti Scalo, Italy
    • Agostino, Consoli
  • Azienda Sanitaria Locale Citta Di Torino, Turin, Italy
    • Salvatore, Oleandri
  • ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy
    • Basilio, Pintaudi
  • Azienda Sanitaria Regionale del Molise (ASREM), Campobasso, Italy
    • Maria Rosaria, Cristofaro
  • University Hospital Of Ferrara, Ferrara, Italy
    • Marcello, Monesi
  • Azienda USL Toscana Centro, Florence, Italy
    • Cristina Maria, Baggiore
  • Ente Ecclesiastico Ospedale Generale Regionale Miulli, Acquaviva Delle Fonti, Italy
    • Lucrezia, Matera
  • Azienda USL Toscana Centro, Pistoia, Italy
    • Roberto, Anichini
  • Azienda Ospedaliero Universitaria Ospedali Riuniti, Foggia, Italy
    • Olga, Lamacchia
  • Azienda USL Toscana Centro, Bagno A Ripoli, Italy
    • Alessandra, De Bellis
  • Azienda Sanitaria Locale 5 Spezzino, La Spezia, Italy
    • Riccardo, Scattina
  • IRCCS Ospedale Policlinico San Martino, Genoa, Italy
    • Davide, Maggi
  • HUS-Yhtymae, Helsinki, Finland
    • Petra, Nikuri

And 1 other sites.