Back to results

Trial to Assess Chelation Therapy 2 (TACT2)

Primary Purpose

Diabetes, Myocardial Infarction

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

disodium EDTA

Oral Multi Vitamins/Minerals (OMVM)

Placebo disodium EDTA

Placebo Oral Multi Vitamins/Minerals (OMVM)

About this trial

This is an interventional prevention trial for Diabetes focused on measuring chelation

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age: ≥ 50 years
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.
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:

Baseline serum creatinine >2.0 mg/dL.
HbA1C >11%.
Myocardial infarction within 6 weeks of randomization.
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.
Coronary or peripheral arterial revascularization procedure performed within the last 6 months.
Planned revascularization procedure in the 6 months following enrollment.
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.
Poor or no venous access in the upper extremities.
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.
Prior participation in TACT.
Baseline platelet count <100,000.
History of cigarette smoking within the last 3 months.
ALT or AST > 2.0 times the upper limit of normal.
Wilson's disease, hemochromatosis, or parathyroid disease.
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.
Any factor that suggests that the potential participant will not be able to adhere to the protocol.
Women of child-bearing potential including those with plans for post-menopausal in vitro fertilization or other reproductive technology.

Sites / Locations

Mount Sinai Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Active/Active

Active/Placebo

Placebo/ Active

Placebo/Placebo

Arm Description

Active disodium EDTA (chelation) + Active Oral Multi Vitamins/Minerals (OMVM)

Active disodium EDTA (chelation) + Placebo Oral Multi Vitamins/Minerals (OMVM)

Placebo disodium EDTA (chelation) + Active Oral Multi Vitamins/Minerals (OMVM)

Placebo disodium EDTA (chelation) + Placebo Oral Multi Vitamins/Minerals (OMVM)

Outcomes

Primary Outcome Measures

A composite of all-cause mortality, myocardial infarction, stroke, coronary revascularization, or hospitalization for unstable angina

Secondary Outcome Measures

Full Information

NCT ID

NCT02733185

First Posted

April 5, 2016

Last Updated

August 11, 2023

Sponsor

Mt. Sinai Medical Center, Miami

Collaborators

National Center for Complementary and Integrative Health (NCCIH), National Heart, Lung, and Blood Institute (NHLBI), Duke Clinical Research Institute

1. Study Identification

Unique Protocol Identification Number

NCT02733185

Brief Title

Trial to Assess Chelation Therapy 2

Acronym

TACT2

Official Title

Trial to Assess Chelation Therapy 2

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Completed

Study Start Date

October 2016 (Actual)

Primary Completion Date

June 30, 2023 (Actual)

Study Completion Date

June 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mt. Sinai Medical Center, Miami

Collaborators

National Center for Complementary and Integrative Health (NCCIH), National Heart, Lung, and Blood Institute (NHLBI), Duke Clinical Research Institute

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes, Myocardial Infarction

Keywords

chelation

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Factorial Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

1000 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Active/Active

Arm Type

Active Comparator

Arm Description

Active disodium EDTA (chelation) + Active Oral Multi Vitamins/Minerals (OMVM)

Arm Title

Active/Placebo

Arm Type

Active Comparator

Arm Description

Active disodium EDTA (chelation) + Placebo Oral Multi Vitamins/Minerals (OMVM)

Arm Title

Placebo/ Active

Arm Type

Active Comparator

Arm Description

Placebo disodium EDTA (chelation) + Active Oral Multi Vitamins/Minerals (OMVM)

Arm Title

Placebo/Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo disodium EDTA (chelation) + Placebo Oral Multi Vitamins/Minerals (OMVM)

Intervention Type

Drug

Intervention Name(s)

disodium EDTA

Other Intervention Name(s)

EDTA

Intervention Type

Dietary Supplement

Intervention Name(s)

Oral Multi Vitamins/Minerals (OMVM)

Intervention Type

Drug

Intervention Name(s)

Placebo disodium EDTA

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo Oral Multi Vitamins/Minerals (OMVM)

Primary Outcome Measure Information:

Title

A composite of all-cause mortality, myocardial infarction, stroke, coronary revascularization, or hospitalization for unstable angina

Time Frame

5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age: ≥ 50 years 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. History of myocardial infarction based on the Universal Definition of MI. When information about the MI hospitalization is available, all MI types except Type 2 qualify for study entry. 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: Baseline serum creatinine >2.0 mg/dL. HbA1C >11%. Myocardial infarction within 6 weeks of randomization. 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. Coronary or peripheral arterial revascularization procedure performed within the last 6 months. Planned revascularization procedure in the 6 months following enrollment. 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. Poor or no venous access in the upper extremities. 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. Prior participation in TACT. Baseline platelet count <100,000. History of cigarette smoking within the last 3 months. ALT or AST > 2.0 times the upper limit of normal. Wilson's disease, hemochromatosis, or parathyroid disease. 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. Any factor that suggests that the potential participant will not be able to adhere to the protocol. Women of child-bearing potential including those with plans for post-menopausal in vitro fertilization or other reproductive technology.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gervasio A Lamas, MD

Organizational Affiliation

Mount Sinai Medical Center of Florida

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Kevin J Anstrom, PhD

Organizational Affiliation

University of North Carolina, Chapel Hill

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Daniel B Mark, MD

Organizational Affiliation

Duke University (Duke Clinical Research Institute)

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mount Sinai Medical Center

City

Miami Beach

State/Province

Florida

ZIP/Postal Code

33132

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

23532240

Citation

Lamas GA, Goertz C, Boineau R, Mark DB, Rozema T, Nahin RL, Lindblad L, Lewis EF, Drisko J, Lee KL; TACT Investigators. Effect of disodium EDTA chelation regimen on cardiovascular events in patients with previous myocardial infarction: the TACT randomized trial. JAMA. 2013 Mar 27;309(12):1241-50. doi: 10.1001/jama.2013.2107.

Results Reference

background

PubMed Identifier

24254885

Citation

Escolar E, Lamas GA, Mark DB, Boineau R, Goertz C, Rosenberg Y, Nahin RL, Ouyang P, Rozema T, Magaziner A, Nahas R, Lewis EF, Lindblad L, Lee KL. The effect of an EDTA-based chelation regimen on patients with diabetes mellitus and prior myocardial infarction in the Trial to Assess Chelation Therapy (TACT). Circ Cardiovasc Qual Outcomes. 2014 Jan;7(1):15-24. doi: 10.1161/CIRCOUTCOMES.113.000663. Epub 2013 Nov 19.

Results Reference

background

PubMed Identifier

24952858

Citation

Lamas GA, Boineau R, Goertz C, Mark DB, Rosenberg Y, Stylianou M, Rozema T, Nahin RL, Terry Chappell L, Lindblad L, Lewis EF, Drisko J, Lee KL. EDTA chelation therapy alone and in combination with oral high-dose multivitamins and minerals for coronary disease: The factorial group results of the Trial to Assess Chelation Therapy. Am Heart J. 2014 Jul;168(1):37-44.e5. doi: 10.1016/j.ahj.2014.02.012. Epub 2014 Apr 2.

Results Reference

background

PubMed Identifier

22172430

Citation

Lamas GA, Goertz C, Boineau R, Mark DB, Rozema T, Nahin RL, Drisko JA, Lee KL. Design of the Trial to Assess Chelation Therapy (TACT). Am Heart J. 2012 Jan;163(1):7-12. doi: 10.1016/j.ahj.2011.10.002.

Results Reference

background

Learn more about this trial

Trial to Assess Chelation Therapy 2

We'll reach out to this number within 24 hrs