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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 Integrative Health (NCCIH)
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
Results First Received: August 30, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Factorial Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Coronary Artery Disease
Interventions: Drug: EDTA
Drug: EDTA Placebo
Dietary Supplement: High Dose Vitamin
Dietary Supplement: High Dose Vitamin Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The primary analysis of the trial included 1708 patients who had been enrolled from September 2003 through October 2011 (median, 55 months)Participants were recruited at 134 sites in the US and Canada.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
EDTA + High Dose Vitamin Participants will receive 40 infusions of active EDTA chelation and active high-dose oral vitamins.
EDTA + High Dose Vitamin Placebo Participants will receive 40 infusions of EDTA chelation and placebo high-dose oral vitamins.
EDTA Placebo + High Dose Vitamin Participants will receive 40 infusions of placebo EDTA chelation and active high-dose oral vitamins.
EDTA Placebo + High Dose Vitamin Placebo Participants will receive 40 infusions of placebo EDTA chelation and placebo high-dose oral vitamins.

Participant Flow:   Overall Study
    EDTA + High Dose Vitamin   EDTA + High Dose Vitamin Placebo   EDTA Placebo + High Dose Vitamin   EDTA Placebo + High Dose Vitamin Placebo
STARTED   421   418   432   437 
COMPLETED   321   306   294   301 
NOT COMPLETED   100   112   138   136 
Withdrawal by Subject                50                65                91                83 
Death                42                42                42                49 
Lost to Follow-up                8                5                5                4 



  Baseline Characteristics


  Outcome Measures
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1.  Primary:   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 ]

2.  Secondary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats


  More Information