Trial to Assess Chelation Therapy (TACT)

This study has been completed.

Sponsor:

Collaborators:

National Heart, Lung, and Blood Institute (NHLBI)

National Center for Complementary and Alternative Medicine (NCCAM)

Information provided by (Responsible Party):

Gervasio Lamas, MD, Mt. Sinai Medical Center, Miami

ClinicalTrials.gov Identifier:

NCT00044213

First received: August 22, 2002

Last updated: May 3, 2013

Last verified: May 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

August 22, 2002

Last Updated Date

May 3, 2013

Start Date ^ICMJE

September 2003

Primary Completion Date

October 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

A composite of total mortality, recurrent myocardial infarction, stroke, coronary revascularization, and hospitalization for angina. [ Time Frame: Measured throughout the study ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00044213 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Trial to Assess Chelation Therapy (TACT)

Official Title ^ICMJE

Trial to Assess Chelation Therapy (TACT)

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 Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Coronary Artery Disease

Intervention ^ICMJE

Drug: EDTA chelation therapy
Participants will receive 40 infusions of standard chelation solution.
Drug: Placebo infusions
Participants will receive 40 infusions of placebo.

Study Arm (s)

Active Comparator: EDTA chelation + high dose vitamin
Participants will receive 40 infusions of active EDTA chelation and active high-dose oral vitamins.

Intervention: Drug: EDTA chelation therapy
Placebo Comparator: EDTA chelation + high dose vitamin placebo
Participants will receive 40 infusions of EDTA chelation and placebo high-dose oral vitamins.

Intervention: Drug: Placebo infusions
Placebo Comparator: EDTA chelation placebo + high dose vitamin
Participants will receive 40 infusions of placebo EDTA chelation and active high-dose oral vitamins.
Placebo Comparator: EDTA chelation placebo + high dose vitamin placebo
Participants will receive 40 infusions of placebo EDTA chelation and placebo high-dose oral vitamins.

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

1708

Completion Date

August 2012

Primary Completion Date

October 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria for Participants:

Heart attack at least 6 weeks prior to study start

Exclusion Criteria for Participants:

Chelation therapy within 5 years prior to study start
History of allergic reactions to EDTA or any of the therapy's components
Coronary or carotid revascularization procedures within 6 months prior to study start or a scheduled revascularization
Cigarette smoking within 3 months prior to study start
Childbearing potential
History of liver disease
Diagnoses of additional medical conditions that could otherwise limit patient survival

Gender

Both

Ages

50 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Canada

Administrative Information

NCT Number ^ICMJE

NCT00044213

Other Study ID Numbers ^ICMJE

654, U01HL092607, U01AT001156

Has Data Monitoring Committee

Yes

Responsible Party

Gervasio Lamas, MD, Mt. Sinai Medical Center, Miami

Study Sponsor ^ICMJE

Mt. Sinai Medical Center, Miami

Collaborators ^ICMJE

National Heart, Lung, and Blood Institute (NHLBI)
National Center for Complementary and Alternative Medicine (NCCAM)

Investigators ^ICMJE

Study Director:

Gervasio A Lamas, M.D.

Mount Sinai School of Medicine

Information Provided By

Mt. Sinai Medical Center, Miami

Verification Date

May 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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