Trial to Assess Chelation Therapy 2

• Status: Active, not recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mt. Sinai Medical Center, Miami
• Collaborators: Duke Clinical Research Institute; National Center for Complementary and Integrative Health (NCCIH); National Heart, Lung, and Blood Institute (NHLBI)
• Treatments: Edetic Acid; Pentetic Acid; Vitamins

Criteria

Inclusion Criteria:

1. Age: ≥ 50 years

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

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

1. When information about the MI hospitalization is available, all MI types except Type 2 qualify for study entry.

2. When information about the MI hospitalization is not available, a wall motion abnormality on imaging or a perfusion defect on scan that corresponds to a coronary distribution, whether or not accompanied by pathological Q waves in the appropriate distribution, will qualify the patient for study entry. This criterion requires a call to the CCC for case review.

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 chelation solution, including heparin. Site personnel are to call the CCC to discuss heparin allergy.

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

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

7. Heart failure hospitalization within 6 months prior to enrollment or in clinical heart failure at the time of proposed enrollment (such as NYHA Class 3 dyspnea + rales >basilar, and additional signs of fluid overload). Such patients may be treated 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; if only 1 infusion took place, patient cannot be enrolled for at least 12 months after said 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-melanoma skin 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 adhere to the protocol.

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