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Trial to Assess Chelation Therapy 2 (TACT2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02733185
Recruitment Status : Suspended (COVID-19)
First Posted : April 11, 2016
Last Update Posted : March 20, 2020
Sponsor:
Collaborators:
National Center for Complementary and Integrative Health (NCCIH)
National Heart, Lung, and Blood Institute (NHLBI)
Duke Clinical Research Institute
Information provided by (Responsible Party):
Gervasio Lamas, MD, Mt. Sinai Medical Center, Miami

Tracking Information
First Submitted Date  ICMJE April 5, 2016
First Posted Date  ICMJE April 11, 2016
Last Update Posted Date March 20, 2020
Actual Study Start Date  ICMJE October 2016
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 5, 2016)
A composite of all-cause mortality, myocardial infarction, stroke, coronary revascularization, or hospitalization for unstable angina [ Time Frame: 5 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial to Assess Chelation Therapy 2
Official Title  ICMJE Trial to Assess Chelation Therapy 2
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • Diabetes
  • Myocardial Infarction
Intervention  ICMJE
  • Drug: disodium EDTA
    Other Name: EDTA
  • Dietary Supplement: Oral Multi Vitamins/Minerals (OMVM)
  • Drug: Placebo disodium EDTA
  • Dietary Supplement: Placebo Oral Multi Vitamins/Minerals (OMVM)
Study Arms  ICMJE
  • Active Comparator: Active/Active
    Active disodium EDTA (chelation) + Active Oral Multi Vitamins/Minerals (OMVM)
    Interventions:
    • Drug: disodium EDTA
    • Dietary Supplement: Oral Multi Vitamins/Minerals (OMVM)
  • Active Comparator: Active/Placebo
    Active disodium EDTA (chelation) + Placebo Oral Multi Vitamins/Minerals (OMVM)
    Intervention: Drug: disodium EDTA
  • Active Comparator: Placebo/ Active
    Placebo disodium EDTA (chelation) + Active Oral Multi Vitamins/Minerals (OMVM)
    Interventions:
    • Dietary Supplement: Oral Multi Vitamins/Minerals (OMVM)
    • Drug: Placebo disodium EDTA
  • Placebo Comparator: Placebo/Placebo
    Placebo disodium EDTA (chelation) + Placebo Oral Multi Vitamins/Minerals (OMVM)
    Interventions:
    • Drug: Placebo disodium EDTA
    • Dietary Supplement: Placebo Oral Multi Vitamins/Minerals (OMVM)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: October 29, 2019)
1100
Original Estimated Enrollment  ICMJE
 (submitted: April 5, 2016)
1200
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02733185
Other Study ID Numbers  ICMJE AT009149-01
UH3AT009149 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gervasio Lamas, MD, Mt. Sinai Medical Center, Miami
Study Sponsor  ICMJE Mt. Sinai Medical Center, Miami
Collaborators  ICMJE
  • National Center for Complementary and Integrative Health (NCCIH)
  • National Heart, Lung, and Blood Institute (NHLBI)
  • Duke Clinical Research Institute
Investigators  ICMJE
Study Chair: Gervasio A Lamas, MD Mount Sinai Medical Center of Florida
Principal Investigator: Kevin J Anstrom, PhD Duke University (Duke Clinical Research Institute)
Principal Investigator: Daniel B Mark, MD Duke University (Duke Clinical Research Institute)
PRS Account Mt. Sinai Medical Center, Miami
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP