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American heart journal · Jan 2012
Randomized Controlled TrialDesign of the Trial to Assess Chelation Therapy (TACT).
- Gervasio A Lamas, Christine Goertz, Robin Boineau, Daniel B Mark, Theodore Rozema, Richard L Nahin, Jeanne A Drisko, and Kerry L Lee.
- Mount Sinai Medical Center, Miami Beach, FL, USA. gervasio.lamas@msmc.com
- Am. Heart J. 2012 Jan 1; 163 (1): 7-12.
AbstractTACT is an National Institutes of Health-sponsored, randomized, double-blind, placebo-controlled, 2 × 2 factorial clinical trial testing the benefits and risks of 40 infusions of a multicomponent disodium EDTA chelation solution compared with placebo and of an oral, high-dose multivitamin and mineral supplement. TACT has randomized and will follow up 1,708 patients for an average of approximately 4 years. The primary end point 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 end point for each treatment factor. Enrollment began in September 2003 and was completed in October 2010.Copyright © 2012 Mosby, Inc. All rights reserved.
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