Design of the Trial to Assess Chelation Therapy (TACT)
- PMID: 22172430
- PMCID: PMC3243954
- DOI: 10.1016/j.ahj.2011.10.002
Design of the Trial to Assess Chelation Therapy (TACT)
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.
Copyright © 2012 Mosby, Inc. All rights reserved.
Comment in
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Letter to the editor concerning article "Design of the Trial to Assess Chelation Therapy (TACT)".Am Heart J. 2012 Dec;164(6):e23; author reply e25. doi: 10.1016/j.ahj.2012.07.009. Epub 2012 Oct 31. Am Heart J. 2012. PMID: 23194497 No abstract available.
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