The effect of low-dose colchicine in patients with stable coronary artery disease: The LoDoCo2 trial rationale, design, and baseline characteristics

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The effect of low-dose colchicine in patients with stable coronary artery disease: The LoDoCo2 trial rationale, design, and baseline characteristics
 
on behalf of the LoDoCo2 Investigators
(2019) American Heart Journal, volume 218, pp. 46 - 56
(Article)
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 ... read more
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Keywords: Cardiology and Cardiovascular Medicine, Journal Article
DOI: https://doi.org/10.1016/j.ahj.2019.09.011
ISSN: 0002-8703
Publisher: Mosby Inc.
Note: Funding Information: In the Netherlands, the study received starting funding from the Withering Stichting Nederland (WSN) foundation and from the members of the WCN. Additional funding was obtained by means of the Netherlands Organization for Health Research and Development and the Netherlands Heart Foundation (ZonMw, rediscovery theme in the Rational Pharmacotherapy program, Grant nr. 848015014). A pharma consortium consisting of Teva, Haarlem, Disphar, Baarn and Tiofarma, Oud-Beijerland, all in the Netherlands provided colchicine and matching placebo tablets at no cost, and in addition an unrestricted research grant. Funding Information: In Australia, the study received seed funding from Sir Charles Gairdner Hospital (Research Advisory Committee of Sir Charles Gairdner Hospital and Osborne Park Group and Charlies Foundation for Research) and major funding from the National Health Medical Research Council of Australia (NHMRC project grant APP 1088455). Aspen Pharmacare Australia provided the colchicine and matching placebo tablets for the trial in Australia at no cost. Further support for infrastructure related to the day to day running of the trial has been provided by GenesisCare Australia. In the Netherlands, the study received starting funding from the Withering Stichting Nederland (WSN) foundation and from the members of the WCN. Additional funding was obtained by means of the Netherlands Organization for Health Research and Development and the Netherlands Heart Foundation (ZonMw, rediscovery theme in the Rational Pharmacotherapy program, Grant nr. 848015014). A pharma consortium consisting of Teva, Haarlem, Disphar, Baarn and Tiofarma, Oud-Beijerland, all in the Netherlands provided colchicine and matching placebo tablets at no cost, and in addition an unrestricted research grant. Investigators with number of participants randomized between parentheses:, Australia: S.M. Nidorf (302), X.F. Xu (255), M.A Ireland (248), D. Latchem (195), A. Whelan (169), R. Hendriks (168), P. Salkani (143), I.W. Tan (96), A.G Thompson (95), A.M. Morton (74), B.E Hockings (72), P.L. Thompson (35), B. King (15). Key Assistant Staff; P. Buczec, D. Craig, K. Doherty, L.P. Nidorf and K. Youl. Netherlands: J.H. Cornel, T.S.J. Opstal and H. Bakker-Lohmeijer (408), A. Mosterd, A.T.L. Fiolet and P. Bunschoten (331), S.H.K. The and S. van der Kooi (268), T. Lenderink and R.G.J.L. Lardinois (198), P.A.M. Hoogslag and A. de Vos (194), A. Jerzewski and S. Jansen (187), P.R. Nierop and M. van der Knaap (179), H.P. Swart and R. Kingma (154), J. Schaap and L.B. Blom (152), A.F.M. Kuijper and E. Bayraktar-Verver (149), M.W.J. van Hessen and W.C.T.C. Engelen (146), J.W.M. van Eck and N. van der Ven-Elzebroek (123), J.C.M. van Hal and I.M.J. Drost (120), F.R. den Hartog and D. van Wijk (98), E. van Beek and C. van der Horst (97), G.L. Bartels and M. Hendriks (93), C. de Nooijer and C. Welten (92), E. Ronner and A. Dijkshoorn (85), F.J. Prins and R.N.A. Rutten (78), D.P.W. Beelen and I. Hendriks (71), A. van der Sluis and E.A. Badings (65), I.C.D. Westendorp and A. Melein (62), R. van de Wal and I. Leenders - van Lieshout (45), Tj. J. Römer and P. Bruines (45), M.E.W. Hemels and K. Meinen-Werner (42), M.R. de Groot and G. Post (34), M.W.C. Mulder and S. Stuij (31), E. van Nes and P. Luyten (30), J. Plomp and S.V. Veldmeijer (22), M.J. Asselman and P.A. Scholtus (19). Key Assistant Staff: V. van Gansevoort, I. Groeneberg, M.T. van Leeuwen, G. Rodrigues, W.A. Tousain, T. de Vries and F. Weerdesteyn. Funding Information: In Australia, the study received seed funding from Sir Charles Gairdner Hospital (Research Advisory Committee of Sir Charles Gairdner Hospital and Osborne Park Group and Charlies Foundation for Research) and major funding from the National Health Medical Research Council of Australia (NHMRC project grant APP 1088455). Aspen Pharmacare Australia provided the colchicine and matching placebo tablets for the trial in Australia at no cost. Further support for infrastructure related to the day to day running of the trial has been provided by GenesisCare Australia. Publisher Copyright: © 2019 Elsevier Inc.
(Peer reviewed)