Trial to Assess Chelation Therapy 2

Last updated: March 24, 2025
Sponsor: Mt. Sinai Medical Center, Miami
Overall Status: Completed

Phase

3

Condition

Coronary Artery Disease

Blood Clots

Congestive Heart Failure

Treatment

disodium EDTA

Oral Multi Vitamins/Minerals (OMVM)

Placebo Oral Multi Vitamins/Minerals (OMVM)

Clinical Study ID

NCT02733185
AT009149-01
UH3AT009149
U24AT009150
UH3AT009150
R01AT009273
  • Ages > 50
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age: ≥ 50 years

  2. History of diabetes, defined as medical record evidence or patient report ofcurrently using insulin or oral hypoglycemic agents, or with a history of fastingblood glucose measurement of 126 mg/dL or higher, or a history of HbA1c of 6.5% orhigher.

  3. History of myocardial infarction based on the Universal Definition of MI.

  4. When information about the MI hospitalization is available, all MI types exceptType 2 qualify for study entry.

  5. When information about the MI hospitalization is not available, a wall motionabnormality on imaging or a perfusion defect on scan that corresponds to acoronary distribution, whether or not accompanied by pathological Q waves inthe appropriate distribution, will qualify the patient for study entry. Thiscriterion requires a call to the CCC for case review.

Exclusion

Exclusion Criteria:

  1. Baseline serum creatinine >2.0 mg/dL.

  2. HbA1C >11%.

  3. Myocardial infarction within 6 weeks of randomization.

  4. History of allergic reactions to EDTA or any other components of the chelationsolution, including heparin. Site personnel are to call the CCC to discuss heparinallergy.

  5. Coronary or peripheral arterial revascularization procedure performed within thelast 6 months.

  6. Planned revascularization procedure in the 6 months following enrollment.

  7. Heart failure hospitalization within 6 months prior to enrollment or in clinicalheart failure at the time of proposed enrollment (such as NYHA Class 3 dyspnea +rales >basilar, and additional signs of fluid overload). Such patients may betreated with diuretics and enrolled when stable.

  8. Poor or no venous access in the upper extremities.

  9. a. Prior intravenous chelation therapy consisting of > 1 infusion within 5 years; ifonly 1 infusion took place, patient cannot be enrolled for at least 12 months aftersaid infusion. b. Oral chelation therapy with an approved oral chelating agent within 2 years.

  10. Prior participation in TACT.

  11. Baseline platelet count <100,000.

  12. History of cigarette smoking within the last 3 months.

  13. ALT or AST > 2.0 times the upper limit of normal.

  14. Wilson's disease, hemochromatosis, or parathyroid disease.

  15. Any medical condition including a current diagnosis of cancer (except non-melanomaskin cancer) that will limit patient survival over the duration of the trial.

  16. Any factor that suggests that the potential participant will not be able to adhereto the protocol.

  17. Women of child-bearing potential including those with plans for post-menopausal invitro fertilization or other reproductive technology.

Study Design

Total Participants: 1000
Treatment Group(s): 4
Primary Treatment: disodium EDTA
Phase: 3
Study Start date:
October 01, 2016
Estimated Completion Date:
June 30, 2023

Study 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.

Connect with a study center

  • Mount Sinai Medical Center

    Miami Beach, Florida 33132
    United States

    Site Not Available

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