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Title: | Low-dose colchicine for the prevention of cardiovascular events after percutaneous coronary intervention: Rationale and design of the COL BE PCI trial | Authors: | De Cock, Emmanuel Kautbally, Shakeel Timmermans, Frank BOGAERTS, Kris Hanet, Claude Desmet, Walter Gurne, Olivier VRANCKX, Pascal Hiltrop, Nick Dujardin, Karl Vanduynhoven, Philippe Vermeersch, Paul Pirlet, Charles Hermans , Kurt Van Reet, Bert Ferdinande, Bert Aminian, Adel Dewilde, Willem Guedes, Antonine Simon, Francois De Roeck, Frederic De Vroey, Frederic Jukema, J. Wouter Sinnaeve, Peter Buysschaert, Ian |
Issue Date: | 2024 | Publisher: | MOSBY-ELSEVIER | Source: | American heart journal, 278 , p. 61 -71 | Abstract: | Introduction Patients with coronar y arter y disease (CAD) remain vulnerable to future major atherosclerotic events after revascularization, despite effective secondary prevention strategies. Inflammation plays a central role in the pathogenesis of CAD and recurrent events. To date, there is no specific anti-inflammatory medicine available with proven effective, costefficient, and favorable benefit-risk profile, except for colchicine. Initial studies with colchicine have sparked major interest in targeting atherosclerotic events with anti-inflammatory agents, but further studies are warranted to enforce the role of colchicine role as a major treatment pillar in CAD. Given colchicine's low cost and established acceptable long-term safety profile, confirming its efficacy through a pragmatic trial holds the potential to significantly impact the global burden of cardiovascular disease. Methods The COL BE PCI trial is an investigator-initiated, multicenter, double-blind, event-driven trial. It will enroll 2,770 patients with chronic or acute CAD treated with percutaneous coronar y inter vention (PCI) at 19 sites in Belgium, applying lenient in- and exclusion criteria and including at least 30% female participants. Patients will be randomized between 2 hours and 5 days post-PCI to receive either colchicine 0.5 mg daily or placebo on top of contemporary optimal medical therapy and without run-in period. All patients will have baseline hsCRP measurements and a Second Manifestations of Arterial Disease (SMART) risk score calculation. The primary endpoint is the time from randomization to the first occurrence of a composite endpoint consisting of all-cause death, spontaneous non-fatal myocardial infarction, non-fatal stroke, or coronary revascularization. The trial is event-driven and will continue until 566 events have been reached, providing 80% power to detect a 21 % reduction in the primary endpoint taking a premature discontinuation of 15% into account. We expect a trial duration of approximately 44 months. Conclusion The COL BE PCI Trial aims to assess the effectiveness and safety of administering low-dose colchicine for the secondary prevention in patients with both chronic and acute coronary artery disease undergoing PCI. Trial registration: ClinicalTrials.gov: NCT06095765 . (Am Heart J 2024;278:61-71.) | Notes: | De Cock, E (corresponding author), AZ St Jan Brugge AV, Dept Cardiol, Ruddershove 10, B-8000 Brugge, Belgium. ian.buysschaert@azsintjan.be |
Document URI: | http://hdl.handle.net/1942/44479 | ISSN: | 0002-8703 | e-ISSN: | 1097-6744 | DOI: | 10.1016/j.ahj.2024.08.022 | ISI #: | 001325297900001 | Rights: | 2024 Elsevier Inc. All rights are reserved, including those for text and data mining, AI training, and similar technologies. | Category: | A1 | Type: | Journal Contribution |
Appears in Collections: | Research publications |
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