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

Sponsor:	National Heart, Lung, and Blood Institute (NHLBI)
Collaborator:	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Trial to Assess Chelation Therapy (TACT)

Resource links provided by NLM:

MedlinePlus related topics: Coronary Artery Disease

U.S. FDA Resources

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:	1700
Study Start Date:	September 2003
Estimated Study Completion Date:	June 2012
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

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

Show 86 Study Locations

Sponsors and Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

National Center for Complementary and Alternative Medicine (NCCAM)

Investigators

Study Director:

Gervasio A Lamas, M.D.

Mount Sinai School of Medicine

More Information

Additional Information:

View the NIH press release and Q & A regarding the study from here. This link exits the ClinicalTrials.gov site

No publications provided by National Heart, Lung, and Blood Institute (NHLBI)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Lamas GA, Goertz C, Boineau R, Mark DB, Rozema T, Nahin RL, Drisko JA, Lee KL. Design of the Trial to Assess Chelation Therapy (TACT). Am Heart J. 2012 Jan;163(1):7-12.

Responsible Party:	Gervasio A. Lamas, MD, Mount Sinai Medical Center
ClinicalTrials.gov Identifier:	NCT00044213 History of Changes
Other Study ID Numbers:	654, U01 HL092607
Study First Received:	August 22, 2002
Last Updated:	July 26, 2010
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases

Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on February 02, 2012