Division of Cardiology, Mount Sinai Medical Center, Miami Beach, FL, USA.
Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC, USA.
Am Heart J. 2022 Oct;252:1-11. doi: 10.1016/j.ahj.2022.05.013. Epub 2022 May 19.
Intravenous edetate disodium-based infusions reduced cardiovascular events in a prior clinical trial. The Trial to Assess Chelation Therapy 2 (TACT2) will replicate the initial study design.
TACT2 is an NIH-sponsored, randomized, 2x2 factorial, double masked, placebo-controlled, multicenter clinical trial testing 40 weekly infusions of a multi-component edetate disodium (disodium ethylenediamine tetra-acetic acid, or NaEDTA)-based chelation solution and twice daily oral, high-dose multivitamin and mineral supplements in patients with diabetes and a prior myocardial infarction (MI). TACT2 completed enrollment of 1000 subjects in December 2020, and infusions in December 2021. Subjects are followed for 2.5 to 5 years. The primary endpoint is time to first occurrence of all-cause mortality, MI, stroke, coronary revascularization, or hospitalization for unstable angina. The trial has >;85% power to detect a 30% relative reduction in the primary endpoint. TACT2 also includes a Trace Metals and Biorepository Core Lab, to test whether benefits of treatment, if present, are due to chelation of lead and cadmium from patients. Design features of TACT2 were chosen to replicate selected features of the first TACT, which demonstrated a significant reduction in cardiovascular outcomes in the EDTA chelation arm compared with placebo among patients with a prior MI, with the largest effect in patients with diabetes.
Results are expected in 2024.
TACT2 may provide definitive evidence of the benefit of edetate disodiumbased chelation on cardiovascular outcomes, as well as the clinical importance of longitudinal changes in toxic metal levels of participants.
静脉内依地酸二钠基输注在先前的临床试验中减少了心血管事件。评估螯合疗法 2 号试验（TACT2）将复制最初的研究设计。
TACT2 是一项由美国国立卫生研究院（NIH）赞助的、随机的、2x2 析因、双盲、安慰剂对照、多中心临床试验，测试 40 次每周的多组分依地酸二钠（乙二胺四乙酸二钠，或 NaEDTA）为基础的螯合溶液和每日两次口服、高剂量多种维生素和矿物质补充剂在患有糖尿病和先前心肌梗死（MI）的患者中的应用。TACT2 于 2020 年 12 月完成了 1000 名受试者的入组，并于 2021 年 12 月进行了输注。受试者随访时间为 2.5 至 5 年。主要终点是首次全因死亡率、MI、中风、冠状动脉血运重建或不稳定型心绞痛住院的时间。该试验有>；85%的效力检测主要终点的 30%相对减少。TACT2 还包括痕量金属和生物库核心实验室，以测试如果存在治疗益处，是否归因于从患者中螯合铅和镉。TACT2 的设计特征是选择复制第一个 TACT 的选定特征，该研究表明在先前有 MI 的患者中，与安慰剂相比，EDTA 螯合组的心血管结局有显著降低，而在糖尿病患者中效果最大。
预计结果将于 2024 年公布。
TACT2 可能提供关于依地酸二钠基螯合对心血管结局的益处的明确证据，以及参与者有毒金属水平的纵向变化的临床重要性。
