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Trial to Assess Chelation Therapy (TACT)

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: NCT00044213
Recruitment Status : Completed
First Posted : August 23, 2002
Results First Posted : November 5, 2013
Last Update Posted : November 5, 2013
Sponsor:
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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Drug: EDTA Drug: EDTA Placebo Dietary Supplement: High Dose Vitamin Dietary Supplement: High Dose Vitamin Placebo Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1708 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Trial to Assess Chelation Therapy (TACT)
Study Start Date : September 2003
Actual Primary Completion Date : October 2011
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: EDTA + high dose vitamin
Participants will receive 40 infusions of active EDTA chelation and active high-dose oral vitamins.
 Drug: EDTA
Participants will receive 40 infusions of standard chelation solution.

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.
 Drug: EDTA
Participants will receive 40 infusions of standard chelation solution.

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.
 Drug: EDTA Placebo
Participants will receive 40 infusions of 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.
 Drug: EDTA Placebo
Participants will receive 40 infusions of EDTA placebo.

Dietary Supplement: High Dose Vitamin Placebo


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00044213


Locations
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Sponsors and Collaborators
Mt. Sinai Medical Center, Miami
National Heart, Lung, and Blood Institute (NHLBI)
National Center for Complementary and Integrative Health (NCCIH)
Investigators
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Study Director: Gervasio A Lamas, M.D. Icahn School of Medicine at Mount Sinai
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Gervasio Lamas, MD, Chair, Department of Medicine- Chief, Division of Cardiology, Mt. Sinai Medical Center, Miami
ClinicalTrials.gov Identifier: NCT00044213    
Other Study ID Numbers: 654
U01HL092607 ( U.S. NIH Grant/Contract )
U01AT001156 ( U.S. NIH Grant/Contract )
First Posted: August 23, 2002    Key Record Dates
Results First Posted: November 5, 2013
Last Update Posted: November 5, 2013
Last Verified: August 2013
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Vitamins
Edetic Acid
Pentetic Acid
 Micronutrients
Physiological Effects of Drugs
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Antidotes
Protective Agents
Iron Chelating Agents