Full Text View
Tabular View
No Study Results Posted
Related Studies
Trial to Assess Chelation Therapy (TACT)
This study is currently recruiting participants.
Study NCT00044213   Information provided by National Heart, Lung, and Blood Institute (NHLBI)
First Received: August 22, 2002   Last Updated: August 24, 2009   History of Changes

August 22, 2002
August 24, 2009
September 2003
December 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00044213 on ClinicalTrials.gov Archive Site
 
 
 
Trial to Assess Chelation Therapy (TACT)
Trial to Assess Chelation Therapy (TACT)

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.

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.

Phase III
Interventional
Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Coronary Artery Disease
  • Drug: EDTA chelation therapy
  • Drug: Placebo infusions
  • Experimental: Participants will receive 40 infusions of standard chelation solution.
  • Placebo Comparator: Participants will receive 40 infusions of placebo.
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
1700
June 2012
December 2011   (final data collection date for primary outcome measure)

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
Both
50 Years and older
No
Contact: NCCAM Clearinghouse 1-888-644-6226
United States,   Canada
 
NCT00044213
Gervasio A. Lamas, MD, Mount Sinai Medical Center
654, U01 HL092607
National Heart, Lung, and Blood Institute (NHLBI)
National Center for Complementary and Alternative Medicine (NCCAM)
Study Director: Gervasio A Lamas, M.D. Mount Sinai School of Medicine
National Heart, Lung, and Blood Institute (NHLBI)
August 2009

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