Design of the Trial to Assess Chelation Therapy (TACT).
Design of the Trial to Assess Chelation Therapy (TACT).
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DOI：
10.1016/j.ahj.2011.10.002
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发表时间：
2012-01
影响因子：
4.8
通讯作者：
Lee, Kerry L.
中科院分区：
文献类型：
--
作者：
Lamas, Gervasio A.;Goertz, Christine;Boineau, Robin;Mark, Daniel B.;Rozema, Theodore;Nahin, Richard L.;Drisko, Jeanne A.;Lee, Kerry L.
The Trial to Assess Chelation Therapy (TACT) is an NIH-sponsored, randomized, double blind, placebo-controlled, 2×2 factorial clinical trial testing the benefits and risks of 40 infusions of a multi-component Na2EDTA-chelation solution compared with placebo, and of an oral, high-dose multivitamin and mineral supplement. TACT has randomized and will follow 1708 patients for an average of approximately 4 years. The primary endpoint is a composite of all cause mortality, myocardial infarction, stroke, coronary revascularization, and hospitalization for angina. A 900 patient substudy will examine quality of life outcomes. The trial is designed to have >85% power to detect a 25% relative reduction in the primary endpoint for each treatment factor. Enrollment began in September 2003 and completed in October 2010.
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