Trial to Assess Chelation Therapy (TACT)

Mt. Sinai Medical Center, Miami

Status and phase: Completed; Phase 3

Conditions: Coronary Artery Disease

Treatments: Drug: EDTA; Dietary Supplement: High Dose Vitamin Placebo; Drug: EDTA Placebo; Dietary Supplement: High Dose Vitamin

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00044213

654

U01HL092607 (U.S. NIH Grant/Contract)

U01AT001156 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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, 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.

Enrollment: 1,708 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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1,708 participants in 4 patient groups, including a placebo group

EDTA + high dose vitamin

Active Comparator group

Description:

Participants will receive 40 infusions of active EDTA chelation and active high-dose oral vitamins.

Treatment:

Drug: EDTA

Dietary Supplement: High Dose Vitamin

EDTA + high dose vitamin placebo

Placebo Comparator group

Description:

Participants will receive 40 infusions of EDTA chelation and placebo high-dose oral vitamins.

Treatment:

Drug: EDTA

Dietary Supplement: High Dose Vitamin Placebo

EDTA placebo + high dose vitamin

Placebo Comparator group

Description:

Participants will receive 40 infusions of placebo EDTA chelation and active high-dose oral vitamins.

Treatment:

Drug: EDTA Placebo

Dietary Supplement: High Dose Vitamin

EDTA placebo + high dose vitamin placebo

Placebo Comparator group

Description:

Participants will receive 40 infusions of placebo EDTA chelation and placebo high-dose oral vitamins.

Treatment:

Drug: EDTA Placebo

Dietary Supplement: High Dose Vitamin Placebo