Trial to Assess Chelation Therapy (TACT)

• ClinicalTrials.gov Identifier: NCT00044213
• Recruitment Status: Completed
• First Posted: August 23, 2002
• Results First Posted: November 5, 2013
• Last Update Posted: November 5, 2013
• Sponsor: Mt. Sinai Medical Center, Miami
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); National Center for Complementary and Integrative Health (NCCIH)
• Information provided by (Responsible Party): Gervasio Lamas, MD, Mt. Sinai Medical Center, Miami

Tracking Information

• First Submitted Date: August 22, 2002
• First Posted Date: August 23, 2002
• Results First Submitted Date: August 30, 2013
• Results First Posted Date: November 5, 2013
• Last Update Posted Date: November 5, 2013
• Study Start Date: September 2003
• Actual Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 30, 2013)

A Composite of Total Mortality, Recurrent Myocardial Infarction, Stroke, Coronary Revascularization, and Hospitalization for Angina. [ Time Frame: Measured over a maximum 5-year follow-up period- 55 month median ]

Number of patients with events (composite of death from any cause, MI, stroke, coronary revascularization or hospitalization for angina) Events were centrally adjudicated where available; otherwise site reported events were used.

• Original Primary Outcome Measures: Not Provided

Current Secondary Outcome Measures (submitted: August 30, 2013)

A Composite of Cardiovascular Death, Non-fatal Myocardial Infarction and Non-fatal Stroke. [ Time Frame: Measured over a maximum 5-year follow-up period- 55 month median ]

Number of patients with events (composite of cardiovascular death, non-fatal MI, non-fatal stroke) Events were centrally adjudicated where available; otherwise site reported events were used.

• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Trial to Assess Chelation Therapy (TACT)
• Official Title: Trial to Assess Chelation Therapy (TACT)
• Brief Summary: The purpose of this study is to determine the safety and effectiveness of ethylene diamine tetra-acetic (EDTA) chelation therapy in individuals with coronary artery disease.

Detailed Description

EDTA chelation therapy involves repeated administrations of a synthetic amino acid to reduce atherosclerotic plaque and other mineral deposits throughout the cardiovascular system.

Participants will be randomly assigned to receive 40 infusions of either the standard chelation solution or placebo. The primary endpoint of this trial will be a composite of all cause mortality, myocardial infarction, stroke, coronary revascularization, and hospitalization for angina.

The results of TACT will provide either a significant positive result or an informative null result upon which rational clinical decision-making and health policy can be based.

• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Factorial Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Coronary Artery Disease

Intervention

• Drug: EDTA
  Participants will receive 40 infusions of standard chelation solution.
• Drug: EDTA Placebo
  Participants will receive 40 infusions of EDTA placebo.
• Dietary Supplement: High Dose Vitamin
• Dietary Supplement: High Dose Vitamin Placebo

Study Arms

• Active Comparator: EDTA + high dose vitamin
  Participants will receive 40 infusions of active EDTA chelation and active high-dose oral vitamins.
  Interventions:

  • Drug: EDTA
  • Dietary Supplement: High Dose Vitamin
• Placebo Comparator: EDTA + high dose vitamin placebo
  Participants will receive 40 infusions of EDTA chelation and placebo high-dose oral vitamins.
  Interventions:

  • Drug: EDTA
  • Dietary Supplement: High Dose Vitamin Placebo
• Placebo Comparator: EDTA placebo + high dose vitamin
  Participants will receive 40 infusions of placebo EDTA chelation and active high-dose oral vitamins.
  Interventions:

  • Drug: EDTA Placebo
  • Dietary Supplement: High Dose Vitamin
• Placebo Comparator: EDTA placebo + high dose vitamin placebo
  Participants will receive 40 infusions of placebo EDTA chelation and placebo high-dose oral vitamins.
  Interventions:

  • Drug: EDTA Placebo
  • Dietary Supplement: High Dose Vitamin Placebo

Publications *

• Escolar E, Ujueta F, Kim H, Mark DB, Boineau R, Nahin RL, Goertz C, Lee KL, Anstrom KJ, Lamas GA. Possible differential benefits of edetate disodium in post-myocardial infarction patients with diabetes treated with different hypoglycemic strategies in the Trial to Assess Chelation Therapy (TACT). J Diabetes Complications. 2020 Aug;34(8):107616. doi: 10.1016/j.jdiacomp.2020.107616. Epub 2020 May 7.
• Mark DB, Anstrom KJ, Clapp-Channing NE, Knight JD, Boineau R, Goertz C, Rozema TC, Liu DM, Nahin RL, Rosenberg Y, Drisko J, Lee KL, Lamas GA; TACT Investigators. Quality-of-life outcomes with a disodium EDTA chelation regimen for coronary disease: results from the trial to assess chelation therapy randomized trial. Circ Cardiovasc Qual Outcomes. 2014 Jul;7(4):508-16. doi: 10.1161/CIRCOUTCOMES.114.000977.
• Lamas GA, Boineau R, Goertz C, Mark DB, Rosenberg Y, Stylianou M, Rozema T, Nahin RL, Lindblad L, Lewis EF, Drisko J, Lee KL; TACT (Trial to Assess Chelation Therapy) Investigators. Oral high-dose multivitamins and minerals after myocardial infarction: a randomized trial. Ann Intern Med. 2013 Dec 17;159(12):797-805. doi: 10.7326/0003-4819-159-12-201312170-00004.
• 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.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 10, 2012): 1708
• Original Enrollment (submitted: June 23, 2005): 2372
• Actual Study Completion Date: August 2012
• Actual Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria for Participants:

• Heart attack at least 6 weeks prior to study start

Exclusion Criteria for Participants:

• Serum creatinie level greater than 2.0 mg/dL
• Platelet count less than 100,000/µL
• Blood pressure greater than 160/100
• Chelation therapy within 5 years prior to study start
• History of allergic reactions to EDTA or any of the therapy's components
• Coronary or carotid revascularization procedures within 6 months prior to study start or a scheduled revascularization
• Cigarette smoking within 3 months prior to study start
• Childbearing potential
• History of liver disease
• Active heart failure or heart failure hospitalization within 6 months.
• Diagnoses of additional medical conditions that could otherwise limit patient survival
• Inability to tolerate 500-mL infusions weekly.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 50 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada, United States

Administrative Information

• NCT Number: NCT00044213
• Other Study ID Numbers: 654; U01HL092607 ( U.S. NIH Grant/Contract ); U01AT001156 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Gervasio Lamas, MD, Mt. Sinai Medical Center, Miami
• Original Responsible Party: Not Provided
• Current Study Sponsor: Mt. Sinai Medical Center, Miami
• Original Study Sponsor: National Center for Complementary and Integrative Health (NCCIH)

Collaborators

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

Investigators

• Study Director: Gervasio A Lamas, M.D.; Icahn School of Medicine at Mount Sinai

• PRS Account: Mt. Sinai Medical Center, Miami
• Verification Date: August 2013