The trial to assess chelation therapy 2 (TACT2): Rationale and design.

Area of Science:

• Cardiovascular Medicine
• Clinical Trials
• Toxicology

Background:

• Previous trials suggest intravenous edetate disodium (Na2EDTA) chelation may reduce cardiovascular events.
• The Trial to Assess Chelation Therapy 2 (TACT2) aims to replicate these findings.

Purpose of the Study:

• To evaluate the efficacy of Na2EDTA-based chelation therapy in preventing cardiovascular events.
• To determine if chelation of toxic metals (lead, cadmium) contributes to treatment benefits.
• To assess the impact of high-dose oral supplements alongside chelation.

Main Methods:

• TACT2 is a randomized, double-masked, placebo-controlled, multicenter trial.
• 1000 patients with diabetes and prior myocardial infarction (MI) received 40 weekly Na2EDTA chelation infusions and/or oral supplements.
• Primary endpoint: time to cardiovascular events (mortality, MI, stroke, revascularization, unstable angina hospitalization).

Main Results:

• Enrollment completed in December 2020; infusions concluded in December 2021.
• Subject follow-up is ongoing for 2.5 to 5 years.
• Results are anticipated in 2024.

Conclusions:

• TACT2 may provide definitive evidence on Na2EDTA chelation's cardiovascular benefits.
• The trial will assess the role of toxic metal chelation in treatment outcomes.
• Findings could inform future cardiovascular disease prevention strategies.