NCT00044213

Trial to Assess Chelation Therapy (TACT)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,708 (actual)
• Sponsor: Mt. Sinai Medical Center, Miami · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DRUG	EDTA	Participants will receive 40 infusions of standard chelation solution.
DRUG	EDTA Placebo	Participants will receive 40 infusions of EDTA placebo.
DIETARY_SUPPLEMENT	High Dose Vitamin
DIETARY_SUPPLEMENT	High Dose Vitamin Placebo

Timeline

• Start date: 2003-09-01
• Primary completion: 2011-10-01
• Completion: 2012-08-01
• First posted: 2002-08-23
• Last updated: 2013-11-05
• Results posted: 2013-11-05

Locations

86 sites across 2 countries: United States, Canada