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Trial to Assess Chelation Therapy (TACT)

This study is currently recruiting participants.
Information provided by National Center for Complementary and Alternative Medicine (NCCAM)

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Descriptive Information Fields
Brief Title  Trial to Assess Chelation Therapy (TACT)
Official Title  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, 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.

Study Phase Phase III
Study Type  Interventional
Study Design  Treatment, Randomized, Double-Blind, Placebo Control, Efficacy Study
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Coronary Artery Disease
Intervention  Drug: EDTA chelation therapy
MEDLINE PMIDs
Links View the NIH press release and Q & A regarding the study from here. This link exits the ClinicalTrials.gov site
Sites are being added frequently; click here to view a current list from the NCCAM web site. This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  1950
Start Date  September 2003
Completion Date July 2009
Eligibility 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
Gender Both
Ages 50 Years and older
Accepts Healthy Volunteers No
Contacts ††
Contact: NCCAM Clearinghouse     1-888-644-6226        
Location Countries  United States,   Canada
Administrative Information Fields
NCT ID  NCT00044213
Organization ID U01 AT001156-01
Secondary IDs ††
Study Sponsor  National Center for Complementary and Alternative Medicine (NCCAM)
Collaborators †† National Heart, Lung, and Blood Institute (NHLBI)
Investigators 
Study Director:     Anthony Lamas, M.D.     Mt. Sinai Medical Center of Florida    
Information Provided By National Center for Complementary and Alternative Medicine (NCCAM)
Verification Date September 2007
First Received Date  August 22, 2002
Last Updated Date September 25, 2007

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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