Trial to Assess Chelation Therapy (TACT)

Study Overview
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Brief Summary
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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
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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, coronary revascularization, and hospitalization for angina. 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.

Official Title
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Trial to Assess Chelation Therapy (TACT)

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Drug: EDTA
* Drug: EDTA Placebo
* Dietary Supplement: High Dose Vitamin
* Dietary Supplement: High Dose Vitamin Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria for Participants: Heart attack at least 6 weeks prior to study start Exclusion Criteria for Participants: 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.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: EDTA + high dose vitamin<br>Participants will receive 40 infusions of active EDTA chelation and active high-dose oral vitamins. | Drug: EDTA<br>* Participants will receive 40 infusions of standard chelation solution.<br>Dietary Supplement: High Dose Vitamin<br> <br> |
| Placebo Comparator: EDTA + high dose vitamin placebo<br>Participants will receive 40 infusions of EDTA chelation and placebo high-dose oral vitamins. | Drug: EDTA<br>* Participants will receive 40 infusions of standard chelation solution.<br>Dietary Supplement: High Dose Vitamin Placebo<br> <br> |
| Placebo Comparator: EDTA placebo + high dose vitamin<br>Participants will receive 40 infusions of placebo EDTA chelation and active high-dose oral vitamins. | Drug: EDTA Placebo<br>* Participants will receive 40 infusions of EDTA placebo.<br>Dietary Supplement: High Dose Vitamin<br> <br> |
| Placebo Comparator: EDTA placebo + high dose vitamin placebo<br>Participants will receive 40 infusions of placebo EDTA chelation and placebo high-dose oral vitamins. | Drug: EDTA Placebo<br>* Participants will receive 40 infusions of EDTA placebo.<br>Dietary Supplement: High Dose Vitamin Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A Composite of Total Mortality, Recurrent Myocardial Infarction, Stroke, Coronary Revascularization, and Hospitalization for Angina. | Number of patients with events (composite of death from any cause, MI, stroke, coronary revascularization or hospitalization for angina) Events were centrally adjudicated where available; otherwise site reported events were used. | Measured over a maximum 5-year follow-up period- 55 month median | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A Composite of Cardiovascular Death, Non-fatal Myocardial Infarction and Non-fatal Stroke. | Number of patients with events (composite of cardiovascular death, non-fatal MI, non-fatal stroke) Events were centrally adjudicated where available; otherwise site reported events were used. | Measured over a maximum 5-year follow-up period- 55 month median |