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Trial to Assess Chelation Therapy (TACT)

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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

Tracking Information
First Submitted Date  ICMJE August 22, 2002
First Posted Date  ICMJE August 23, 2002
Results First Submitted Date  ICMJE August 30, 2013
Results First Posted Date  ICMJE November 5, 2013
Last Update Posted Date November 5, 2013
Study Start Date  ICMJE September 2003
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial to Assess Chelation Therapy (TACT)
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Coronary Artery Disease
Intervention  ICMJE
  • 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  ICMJE
  • 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 *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 10, 2012)
1708
Original Enrollment  ICMJE
 (submitted: June 23, 2005)
2372
Actual Study Completion Date  ICMJE August 2012
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00044213
Other Study ID Numbers  ICMJE 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  ICMJE Not Provided
Responsible Party Gervasio Lamas, MD, Mt. Sinai Medical Center, Miami
Study Sponsor  ICMJE Mt. Sinai Medical Center, Miami
Collaborators  ICMJE
  • National Heart, Lung, and Blood Institute (NHLBI)
  • National Center for Complementary and Integrative Health (NCCIH)
Investigators  ICMJE
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

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