Please use this identifier to cite or link to this item: http://hdl.handle.net/1942/44479
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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