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Randomized Controlled Trial
. 2012 Jan;163(1):7-12.
doi: 10.1016/j.ahj.2011.10.002.

Design of the Trial to Assess Chelation Therapy (TACT)

Gervasio A Lamas  1 , Christine Goertz, Robin Boineau, Daniel B Mark, Theodore Rozema, Richard L Nahin, Jeanne A Drisko, Kerry L Lee
Affiliations
Randomized Controlled Trial

Design of the Trial to Assess Chelation Therapy (TACT)

Gervasio A Lamas et al. Am Heart J. 2012 Jan.

Abstract

TACT 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.

Trial registration: ClinicalTrials.gov NCT00044213.

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