At a glance
ClinicalIndex Comparison Record- ✓Age ≥50 years
- ✓History of diabetes (insulin/oral agent use, prior fasting glucose ≥126 mg/dL, or HbA1c ≥6.5%)
- ✓History of myocardial infarction per Universal Definition, including Type 1, 2a, 2b, 3, or 4a; or wall motion abnormality/perfusion defect in coronary distribution
- ✕Baseline serum creatinine >2.0 mg/dL
- ✕HbA1c >11%
- ✕Myocardial infarction within 6 weeks of randomization
- ✕Allergy to EDTA or components of chelation solution including heparin
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Trial to Assess Chelation Therapy 2
In Brief
A Phase 3 clinical trial evaluating disodium EDTA, Oral Multi Vitamins/Minerals (OMVM), and 2 other interventions for Diabetes and Myocardial Infarction. Completed, enrolled 1,000 participants across 1 site.
Detailed 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).
Study Details
Timeline
Interventions
IV Disodium Ethylene diamine tetra acetic acid in 500 cc
6 tablets of Multi-vitamin/Multimineral daily
IV Placebo comparator- 500 normal saline
6 tablets of a placebo Multi-vitamin/Multimineral daily