Trial to Assess Chelation Therapy (TACT)

Phase 3

Completed

• Conditions: Coronary Artery Disease
• Interventions: Drug: EDTA Placebo; Drug: EDTA; Dietary Supplement: High Dose Vitamin; Dietary Supplement: High Dose Vitamin Placebo

• Registration Number: NCT00044213
• Lead Sponsor: Mt. Sinai Medical Center, Miami

Brief Summary

The purpose of this study is to determine the safety and effectiveness of ethylene diamine tetra-acetic (EDTA) chelation therapy in individuals with coronary artery disease.

Detailed Description

EDTA chelation therapy involves repeated administrations of a synthetic amino acid to reduce atherosclerotic plaque and other mineral deposits throughout the cardiovascular system.

Participants will be randomly assigned to receive 40 infusions of either the standard chelation solution or placebo. The primary endpoint of this trial will be a composite of all cause mortality, myocardial infarction, stroke, coronary revascularization, and hospitalization for angina.

The results of TACT will provide either a significant positive result or an informative null result upon which rational clinical decision-making and health policy can be based.

Study Timeline

• Study First Submitted: 2002-08-22
• Study First Submitted QC: 2002-08-22
• Study First Posted: 2002-08-23
• Study Start: 2003-09
• Primary Completion: 2011-10
• Study Completion: 2012-08
• Disposition First Submitted: 2013-05-03
• Disposition First Submitted QC: 2013-05-03
• Disposition First Posted: 2013-05-13
• Status Verified: 2013-08
• Results First Submitted: 2013-08-30
• Results First Submitted QC: 2013-08-30
• Last Update Submitted: 2013-08-30
• Results First Posted: 2013-11-05
• Last Update Posted: 2013-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1708

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
EDTA placebo + high dose vitamin placebo	EDTA Placebo	Participants will receive 40 infusions of placebo EDTA chelation and placebo high-dose oral vitamins.
EDTA + high dose vitamin	High Dose Vitamin	Participants will receive 40 infusions of active EDTA chelation and active high-dose oral vitamins.
EDTA + high dose vitamin placebo	High Dose Vitamin Placebo	Participants will receive 40 infusions of EDTA chelation and placebo high-dose oral vitamins.
EDTA placebo + high dose vitamin	EDTA Placebo	Participants will receive 40 infusions of placebo EDTA chelation and active high-dose oral vitamins.
EDTA placebo + high dose vitamin	High Dose Vitamin	Participants will receive 40 infusions of placebo EDTA chelation and active high-dose oral vitamins.
EDTA placebo + high dose vitamin placebo	High Dose Vitamin Placebo	Participants will receive 40 infusions of placebo EDTA chelation and placebo high-dose oral vitamins.
EDTA + high dose vitamin	EDTA	Participants will receive 40 infusions of active EDTA chelation and active high-dose oral vitamins.
EDTA + high dose vitamin placebo	EDTA	Participants will receive 40 infusions of EDTA chelation and placebo high-dose oral vitamins.

Primary Outcome Measures

Name	Time	Method
A Composite of Total Mortality, Recurrent Myocardial Infarction, Stroke, Coronary Revascularization, and Hospitalization for Angina.	Measured over a maximum 5-year follow-up period- 55 month median	Number of patients with events (composite of death from any cause, MI, stroke, coronary revascularization or hospitalization for angina) Events were centrally adjudicated where available; otherwise site reported events were used.

Secondary Outcome Measures

Name	Time	Method
A Composite of Cardiovascular Death, Non-fatal Myocardial Infarction and Non-fatal Stroke.	Measured over a maximum 5-year follow-up period- 55 month median	Number of patients with events (composite of cardiovascular death, non-fatal MI, non-fatal stroke) Events were centrally adjudicated where available; otherwise site reported events were used.

Trial Locations

Locations (86)

Central Arkansas Veterans Healthcare System; 🇺🇸 Little Rock, Arkansas, United States

University of Arkansas for Medical Sciences; 🇺🇸 Little Rock, Arkansas, United States

Mt Holistic Health Center; 🇺🇸 Danville, California, United States

Patrick A. Golden; 🇺🇸 Fresno, California, United States

Scripps Center for Integrative Medicine; 🇺🇸 La Jolla, California, United States

Phoenix Wellness Group; 🇺🇸 Napa, California, United States

Aurora Denver Cardiology Associates; 🇺🇸 Denver, Colorado, United States

The Blend Institute; 🇺🇸 Bradenton, Florida, United States

Wellness Works; 🇺🇸 Brandon, Florida, United States

Innovative Research of West Florida; 🇺🇸 Clearwater, Florida, United States

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