Trial to Assess Chelation Therapy (TACT) - Full Text View

Sponsors and Collaborators:	National Heart, Lung, and Blood Institute (NHLBI) National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by:	National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:	NCT00044213

Purpose

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.

Condition	Intervention	Phase
Coronary Artery Disease	Drug: EDTA chelation therapy Drug: Placebo infusions	Phase III

MedlinePlus related topics: Coronary Artery Disease

U.S. FDA Resources

Study Type:

Interventional

Study Design:

Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Official Title:

Trial to Assess Chelation Therapy (TACT)

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Primary Outcome Measures:

All cause mortality, myocardial infarction, stroke, hospitalization for angina and hospitalization for congestive heart failure [ Time Frame: Measured throughout the study ] [ Designated as safety issue: Yes ]

Estimated Enrollment:

1950

Study Start Date:

September 2003

Estimated Study Completion Date:

July 2010

Estimated Primary Completion Date:

July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Participants will receive 40 infusions of standard chelation solution.	Drug: EDTA chelation therapy Participants will receive 40 infusions of standard chelation solution.
2: Placebo Comparator Participants will receive 40 infusions of placebo.	Drug: Placebo infusions Participants will receive 40 infusions of placebo.

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, hospitalization for angina and hospitalization for congestive heart failure.

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.

Eligibility

Ages Eligible for Study:

50 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00044213

Contacts

Contact: NCCAM Clearinghouse

1-888-644-6226