Trial to Assess Chelation Therapy (TACT)

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Gervasio Lamas, MD, Mt. Sinai Medical Center, Miami
ClinicalTrials.gov Identifier:
NCT00044213
First received: August 22, 2002
Last updated: August 30, 2013
Last verified: August 2013
  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
Drug: EDTA Placebo
Dietary Supplement: High Dose Vitamin
Dietary Supplement: High Dose Vitamin Placebo
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:


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 over a maximum 5-year follow-up period- 55 month median ] [ Designated as safety issue: No ]
    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:
  • 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 ] [ Designated as safety issue: No ]
    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.


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 + 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

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:

  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00044213

  Show 86 Study Locations
Sponsors and Collaborators
Mt. Sinai Medical Center, Miami
Investigators
Study Director: Gervasio A Lamas, M.D. Mount Sinai School of Medicine
  More Information

Additional Information:
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
Results First Received: August 30, 2013
Last Updated: August 30, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases
Vitamins
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 20, 2014