Stefan M Nidorf1, Aernoud T L Fiolet2, John W Eikelboom3, Astrid Schut4, Tjerk S J Opstal5, Willem A Bax6, Charley A Budgeon7, Jan G P Tijssen8, Arend Mosterd9, Jan H Cornel10, Peter L Thompson11. 1. GenesisCare Western Australia, Perth, Australia; Heart Research Institute of Western Australia, Perth, Australia. 2. Dutch Network for Cardiovascular Research (WCN), Utrecht, The Netherlands; The Netherlands Heart Institute, Utrecht, The Netherlands; Department of Cardiology, University Medical Center Utrecht, Utrecht, The Netherlands. 3. Department of Medicine, McMaster University, Hamilton, Ontario, Canada. 4. Dutch Network for Cardiovascular Research (WCN), Utrecht, The Netherlands. 5. Dutch Network for Cardiovascular Research (WCN), Utrecht, The Netherlands; Department of Cardiology, Northwest Clinics, Alkmaar, The Netherlands. 6. Dutch Network for Cardiovascular Research (WCN), Utrecht, The Netherlands; Department of Internal Medicine, Northwest Clinics, Alkmaar, The Netherlands. 7. Department of Cardiovascular Sciences, University of Leicester, and the NIHR Leicester Cardiovascular Biomedical Research Unit Glenfield Hospital, Leicester, United Kingdom; Centre for Applied Statistics, University of Western Australia, Perth, Australia. 8. Department of Cardiology, Amsterdam UMC, Amsterdam, The Netherlands. 9. Dutch Network for Cardiovascular Research (WCN), Utrecht, The Netherlands; Department of Cardiology, Meander Medical Center, Amersfoort, The Netherlands. 10. Dutch Network for Cardiovascular Research (WCN), Utrecht, The Netherlands; Department of Cardiology, Northwest Clinics, Alkmaar, The Netherlands; Department of Cardiology, Radboud University Medical Center, The Netherlands. Electronic address: J.H.Cornel@nwz.nl. 11. Heart Research Institute of Western Australia, Perth, Australia; Sir Charles Gairdner Hospital, Perth, Australia.
Abstract
Because patients with stable coronary artery disease are at continued risk of major atherosclerotic events despite effective secondary prevention strategies, there is a need to continue to develop additional safe, effective and well-tolerated therapies for secondary prevention of cardiovascular disease. RATIONALE AND DESIGN: The LoDoCo (Low Dose Colchicine) pilot trial showed that the anti-inflammatory drug colchicine 0.5 mg once daily appears safe and effective for secondary prevention of cardiovascular disease. Colchicine's low cost and long-term safety suggest that if its efficacy can be confirmed in a rigorous trial, repurposing it for secondary prevention of cardiovascular disease would have the potential to impact the global burden of cardiovascular disease. LoDoCo2 is an investigator-initiated, international, multicentre, double-blind, event driven trial in which 5522 patients with stable coronary artery disease tolerant tocolchicine during a 30-day run-in phase have been randomized to colchicine 0.5 mg daily or matching placebo on a background of optimal medical therapy. The study will have 90% power to detect a 30% reduction in the composite primary endpoint: cardiovascular death, myocardial infarction, ischemic stroke and ischemia-driven coronary revascularization. Adverse events potentially related to the use of colchicine will also be collected, including late gastrointestinal intolerance, neuropathy, myopathy, myositis, and neutropenia. CONCLUSION: The LoDoCo2 Trial will provide information on the efficacy and safety of low-dose colchicine for secondary prevention in patients with stable coronary artery disease.
RCT Entities:
Because patients with stable coronary artery disease are at continued risk of major atherosclerotic events despite effective secondary prevention strategies, there is a need to continue to develop additional safe, effective and well-tolerated therapies for secondary prevention of cardiovascular disease. RATIONALE AND DESIGN: The LoDoCo (Low Dose Colchicine) pilot trial showed that the anti-inflammatory drug colchicine 0.5 mg once daily appears safe and effective for secondary prevention of cardiovascular disease. Colchicine's low cost and long-term safety suggest that if its efficacy can be confirmed in a rigorous trial, repurposing it for secondary prevention of cardiovascular disease would have the potential to impact the global burden of cardiovascular disease. LoDoCo2 is an investigator-initiated, international, multicentre, double-blind, event driven trial in which 5522 patients with stable coronary artery disease tolerant to colchicine during a 30-day run-in phase have been randomized to colchicine 0.5 mg daily or matching placebo on a background of optimal medical therapy. The study will have 90% power to detect a 30% reduction in the composite primary endpoint: cardiovascular death, myocardial infarction, ischemic stroke and ischemia-driven coronary revascularization. Adverse events potentially related to the use of colchicine will also be collected, including late gastrointestinal intolerance, neuropathy, myopathy, myositis, and neutropenia. CONCLUSION: The LoDoCo2 Trial will provide information on the efficacy and safety of low-dose colchicine for secondary prevention in patients with stable coronary artery disease.
Authors: Amber van Broekhoven; Niekbachsh Mohammadnia; Max J M Silvis; Jonathan Los; Aernoud T L Fiolet; Tjerk S J Opstal; Arend Mosterd; John W Eikelboom; Stefan M Nidorf; Charley A Budgeon; Elizabeth Byrnes; Willem A Bax; Jan G P Tijssen; Dominique P V de Kleijn; Peter L Thompson; Saloua El Messaoudi; Jan H Cornel Journal: Clin Drug Investig Date: 2022-10-08 Impact factor: 3.580
Authors: Alberto Cecconi; Jean Paul Vilchez-Tschischke; Jesus Mateo; Javier Sanchez-Gonzalez; Samuel España; Rodrigo Fernandez-Jimenez; Beatriz Lopez-Melgar; Leticia Fernández Friera; Gonzalo J López-Martín; Valentin Fuster; Jesus Ruiz-Cabello; Borja Ibañez Journal: J Cardiovasc Transl Res Date: 2020-03-05 Impact factor: 4.132
Authors: Max J M Silvis; Evelyne J Demkes; Aernoud T L Fiolet; Mirthe Dekker; Lena Bosch; Gerardus P J van Hout; Leo Timmers; Dominique P V de Kleijn Journal: J Cardiovasc Transl Res Date: 2020-07-09 Impact factor: 4.132