TACT

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Rim Halaby, M.D. [2]

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
Study Completion Date	August 2012
Primary Completion 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 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.

Outcomes

Primary Outcomes

A composite of total mortality, recurrent myocardial infarction, stroke, coronary revascularization, and hospitalization for angina.

Secondary Outcomes

A composite of cardiovascular death, non-fatal myocardial infarction and non-fatal stroke.

Publications

Stable Post-Myocardial Infarction Patients

A follow up period of 55 months revealed a modest decrease in the adverse cardiovascular outcomes risks. In fact, 30% of post-MI patients who did not receive chelation therapy were reported to have the primary outcome compared to 26% of those who received the chelation therapy ( HR: 0.82; 95% CI: 0.69-0.99; p= 0.035). The association between chelation therapy and decrease in the risk of each of the components of the primary outcome was significant except for total mortality. Despite the moderate improvement in the cardiovascular outcomes, the findings of this study were not enough to promote chelation therapy as a treatment for stable post-myocardial infarct patients.

Diabetic Post-Myocardial Infarction Patients

The effect of chelation therapy on cardiovascular outcomes was investigated among diabetic patients enrolled in TACT. Among TACT enrolled patients, 633 patients had diabetes which was defined as self-reported diabetes, taking treatment for diabetes or having a fasting blood glucose superior to 126 mg/dL at enrollment. The use of chelation therapy infusions among post-myocardial infarction diabetic patients was associated with decrease in the primary endpoint. In fact, the primary end point occurred in 25 % of diabetic patients who were administered the chelation therapy compared to 38% in those who were not (HR, 0.59; 95% CI, 0.44–0.79; P<0.001). The effect of chelation therapy on the primary endpoint remained significant following adjustment for multiple subgroups (99.4% CI, 0.39–0.88; adjusted P=0.002). In addition, chelation therapy was associated with decreased all-cause mortality, an association that was no longer significant following adjustment for multiple subgroups.