NCT02733185

Trial to Assess Chelation Therapy 2

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,000 (actual)
• Sponsor: Mt. Sinai Medical Center, Miami · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

Trial to Assess Chelation Therapy 2 (TACT2) is a randomized, double blind controlled factorial clinical trial of edetate disodium-based chelation and high-dose oral vitamins and minerals to prevent recurrent cardiac events in diabetic patients with a prior myocardial infarction (MI).

Detailed description

The primary objective of TACT2, therefore, is to determine if the chelation-based strategy increases the time to the first occurrence of any of the components of the TACT2 primary endpoint: all-cause mortality, myocardial infarction, stroke, coronary revascularization, or hospitalization for unstable angina compared to the placebo chelation strategy. TACT2 is a 2x2 factorial trial testing 40-weekly edetate disodium-based chelation infusions and twice daily high-dose oral multivitamins and multiminerals (OMVM) in a placebo-controlled design. TACT2 is being carried out to replicate the findings of TACT1, which found a striking reduction of recurrent cardiovascular events in post-MI diabetic patients receiving edetate disodium-based chelation therapy.

Conditions

• Diabetes
• Myocardial Infarction

Interventions

Type	Name	Description
DRUG	disodium EDTA	IV Disodium Ethylene diamine tetra acetic acid in 500 cc
DIETARY_SUPPLEMENT	Oral Multi Vitamins/Minerals (OMVM)	6 tablets of Multi-vitamin/Multimineral daily
DRUG	Placebo disodium EDTA	IV Placebo comparator- 500 normal saline
DIETARY_SUPPLEMENT	Placebo Oral Multi Vitamins/Minerals (OMVM)	6 tablets of a placebo Multi-vitamin/Multimineral daily

Timeline

• Start date: 2016-10-01
• Primary completion: 2023-06-30
• Completion: 2023-06-30
• First posted: 2016-04-11
• Last updated: 2025-03-30
• Results posted: 2024-10-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study