Conditions: Coronary Artery Disease
Allocation: RANDOMIZED | Intervention model: FACTORIAL
Enrollment: 1708
Healthy volunteers: no

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, 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.

Arms:
arm 1: Participants will receive 40 infusions of active EDTA chelation and active high-dose oral vitamins. arm 2: Participants will receive 40 infusions of EDTA chelation and placebo high-dose oral vitamins. arm 3: Participants will receive 40 infusions of placebo EDTA chelation and active high-dose oral vitamins. arm 4: Participants will receive 40 infusions of placebo EDTA chelation and placebo high-dose oral vitamins.

Interventions: intervention 1: EDTA intervention 2: EDTA Placebo intervention 3: High Dose Vitamin intervention 4: High Dose Vitamin Placebo
Intervention descriptions: intervention 1: Participants will receive 40 infusions of standard chelation solution. intervention 2: Participants will receive 40 infusions of EDTA placebo. intervention 3: None intervention 4: None

Protocol document: