Department of Cardiology, AZ Sint-Jan Brugge AV, Bruges, Belgium; Department of Cardiology, Ghent University Hospital, Ghent, Belgium.
Department of Cardiology, Cliniques Universitaires St-Luc, Université Catholique de Louvain, Brussels, Belgium.
Am Heart J. 2024 Dec;278:61-71. doi: 10.1016/j.ahj.2024.08.022. Epub 2024 Sep 2.
Patients with coronary artery 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, cost-efficient, 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.
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 coronary intervention (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.
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.
ClinicalTrials.gov: NCT06095765.
尽管采取了有效的二级预防策略，患有冠状动脉疾病 (CAD) 的患者在血运重建后仍然容易发生未来的主要动脉粥样硬化事件。炎症在 CAD 和复发性事件的发病机制中起核心作用。迄今为止，除了秋水仙碱外，尚无具有明确疗效、成本效益高且获益风险比有利的特定抗炎药物。秋水仙碱的初步研究激发了用抗炎药物靶向动脉粥样硬化事件的主要兴趣，但需要进一步的研究来证实秋水仙碱作为 CAD 主要治疗支柱的作用。鉴于秋水仙碱的低成本和已确立的可接受的长期安全性，通过一项实用试验证实其疗效有可能显著降低全球心血管疾病负担。
COL BE PCI 试验是一项由研究者发起的、多中心、双盲、事件驱动的试验。它将在比利时的 19 个地点招募 2770 名接受经皮冠状动脉介入治疗 (PCI) 的慢性或急性 CAD 患者，采用宽松的纳入和排除标准，包括至少 30%的女性参与者。患者将在 PCI 后 2 小时至 5 天内随机分为两组，一组接受每日 0.5 毫克秋水仙碱治疗，另一组接受安慰剂治疗，同时接受当代最佳药物治疗，且无洗脱期。所有患者将进行基线 hsCRP 测量和 Second Manifestations of Arterial Disease (SMART) 风险评分计算。主要终点是从随机分组到首次发生全因死亡、自发性非致死性心肌梗死、非致死性卒中和冠状动脉血运重建的复合终点的时间。该试验是事件驱动的，将继续进行，直到达到 566 个事件，考虑到 15%的提前终止，有 80%的效能检测出主要终点降低 21%。我们预计试验持续时间约为 44 个月。
COL BE PCI 试验旨在评估在接受 PCI 治疗的慢性和急性冠状动脉疾病患者中，给予低剂量秋水仙碱进行二级预防的有效性和安全性。
ClinicalTrials.gov：NCT06095765。
