Trial record 1 of 81 for:    chelation AND heart
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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

August 22, 2002
August 30, 2013
September 2003
October 2011   (final data collection date for primary outcome measure)
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.
Not Provided
Complete list of historical versions of study NCT00044213 on ClinicalTrials.gov Archive Site
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.
Not Provided
Not Provided
Not Provided
 
Trial to Assess Chelation Therapy (TACT)
Trial to Assess Chelation Therapy (TACT)

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Coronary Artery Disease
  • 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
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1708
August 2012
October 2011   (final data collection date for primary outcome measure)

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.
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00044213
654, U01HL092607, U01AT001156
Yes
Gervasio Lamas, MD, Mt. Sinai Medical Center, Miami
Mt. Sinai Medical Center, Miami
  • National Heart, Lung, and Blood Institute (NHLBI)
  • National Center for Complementary and Alternative Medicine (NCCAM)
Study Director: Gervasio A Lamas, M.D. Mount Sinai School of Medicine
Mt. Sinai Medical Center, Miami
August 2013

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