Text Size

Trial to Assess Chelation Therapy (TACT)

This study has been completed.
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by (Responsible Party):
Gervasio Lamas, MD, Mt. Sinai Medical Center, Miami
ClinicalTrials.gov Identifier:
NCT00044213
First received: August 22, 2002
Last updated: May 3, 2013
Last verified: May 2013
History of Changes
  Purpose

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 Intervention Phase
Coronary Artery Disease
 Drug: EDTA chelation therapy
Drug: Placebo infusions
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Trial to Assess Chelation Therapy (TACT)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mt. Sinai Medical Center, Miami:

Primary Outcome Measures:
  • A composite of total mortality, recurrent myocardial infarction, stroke, coronary revascularization, and hospitalization for angina. [ Time Frame: Measured throughout the study ] [ Designated as safety issue: Yes ]

Enrollment: 1708
Study Start Date: September 2003
Study Completion Date: August 2012
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: EDTA chelation + high dose vitamin
Participants will receive 40 infusions of active EDTA chelation and active high-dose oral vitamins.
 Drug: EDTA chelation therapy
Participants will receive 40 infusions of standard chelation solution.
Placebo Comparator: EDTA chelation + high dose vitamin placebo
Participants will receive 40 infusions of EDTA chelation and placebo high-dose oral vitamins.
 Drug: Placebo infusions
Participants will receive 40 infusions of placebo.
Placebo Comparator: EDTA chelation placebo + high dose vitamin
Participants will receive 40 infusions of placebo EDTA chelation and active high-dose oral vitamins.
Placebo Comparator: EDTA chelation placebo + high dose vitamin placebo
Participants will receive 40 infusions of placebo EDTA chelation and placebo high-dose oral vitamins.

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria for Participants:

  • Heart attack at least 6 weeks prior to study start

Exclusion Criteria for Participants:

  • 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
  • Diagnoses of additional medical conditions that could otherwise limit patient survival
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00044213

  Show 86 Study Locations
Sponsors and Collaborators
Mt. Sinai Medical Center, Miami
National Heart, Lung, and Blood Institute (NHLBI)
National Center for Complementary and Alternative Medicine (NCCAM)
Investigators
Study Director: Gervasio A Lamas, M.D. Mount Sinai School of Medicine
  More Information

Additional Information:
View the NIH press release and Q & A regarding the study from here.  This link exits the ClinicalTrials.gov site

No publications provided by Mt. Sinai Medical Center, Miami

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Gervasio Lamas, MD, Chair, Department of Medicine- Chief, Division of Cardiology, Mt. Sinai Medical Center, Miami
ClinicalTrials.gov Identifier: NCT00044213     History of Changes
Other Study ID Numbers: 654, U01HL092607, U01AT001156
Study First Received: August 22, 2002
Last Updated: May 3, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Edetic Acid
Vitamins
 Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Chelating Agents
Molecular Mechanisms of Pharmacological Action
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 19, 2013