title: 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.
authors.affiliation: Mount Sinai Medical Center, Miami Beach, FL, USA. gervasio.lamas@msmc.com
authors.forename: Gervasio A
authors.initials: GA
authors.lastname: Lamas
authors.forename: Christine
authors.initials: C
authors.lastname: Goertz
authors.forename: Robin
authors.initials: R
authors.lastname: Boineau
authors.forename: Daniel B
authors.initials: DB
authors.lastname: Mark
authors.forename: Theodore
authors.initials: T
authors.lastname: Rozema
authors.forename: Richard L
authors.initials: RL
authors.lastname: Nahin
authors.forename: Jeanne A
authors.initials: JA
authors.lastname: Drisko
authors.forename: Kerry L
authors.initials: KL
authors.lastname: Lee
mesh_terms: D002614:Chelating Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D015913:Chelation Therapy; D000529:Complementary Therapies; D003324:Coronary Artery Disease / Q000188:drug therapy*; D019587:Dietary Supplements; D004311:Double-Blind Method; D004492:Edetic Acid / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D008903:Minerals / Q000008:administration & dosage; D012107:Research Design; D016896:Treatment Outcome; D014815:Vitamins / Q000008:administration & dosage*
chemical_list: D002614:Chelating Agents; D008903:Minerals; D014815:Vitamins; D004492:Edetic Acid