TACT

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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]

Official Title

Trial to Assess Chelation Therapy (TACT)

Objective

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.

Sponsor

Mt. Sinai Medical Center, Miami

Timeline

Timeline
Start Date	September 2003
Run-In Period	August 2012
End Date	October 2011
Status	Completed

The previous information was derived from ClinicalTrials.gov on 11/19/2013 using the identification number NCT00044213.

Study Description

Study Description
Study Type	Interventional
Study Phase	Phase 3
Study Design
Allocation	Randomized
Endpoint	Efficacy Study
Interventional Model	Factorial Assignment
Masking	Double Blind (Subject, Investigator)
Study Details
Primary Purpose	Treatment
Condition	Coronary artery disease
Intervention	EDTA <vs> EDTA placebo High dose vitamin High dose vitamin placebo
Study Arms	Active Comparator: EDTA + high dose vitamin Placebo Comparator: EDTA + high dose vitamin placebo Placebo Comparator: EDTA placebo + high dose vitamin Placebo Comparator: EDTA placebo + high dose vitamin placebo
Population Size	1708

The previous information was derived from ClinicalTrials.gov on 11/19/2013 using the identification number NCT00044213.

Eligibility Criteria

Inclusion Criteria

• Heart attack at least 6 weeks prior to study start

Exclusion Criteria

• Serum creatinie level greater than 2.0 mg/dL
• Platelet count less than 100,000/µL
• Blood pressure greater than 160/100
• 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
• Active heart failure or heart failure hospitalization within 6 months.
• Diagnoses of additional medical conditions that could otherwise limit patient survival
• Inability to tolerate 500-mL infusions weekly.