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Trial to Assess Chelation Therapy 2

NCT02733185 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1000

Last updated 2025-03-30

Study results available
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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).

Conditions

Interventions

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

Sponsors & Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

    collaborator NIH

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Duke Clinical Research Institute

    collaborator OTHER

  • Mt. Sinai Medical Center, Miami

    lead OTHER

Principal Investigators

  • Gervasio A Lamas, MD · Mount Sinai Medical Center of Florida

  • Kevin J Anstrom, PhD · University of North Carolina, Chapel Hill

  • Daniel B Mark, MD · Duke University (Duke Clinical Research Institute)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
FACTORIAL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-01
Primary Completion
2023-06-30
Completion
2023-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02733185 on ClinicalTrials.gov