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
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


  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.
Total Total of all reporting groups

Baseline Measures
    EDTA + High Dose Vitamin     EDTA + High Dose Vitamin Placebo     EDTA Placebo + High Dose Vitamin     EDTA Placebo + High Dose Vitamin Placebo     Total  
Number of Participants  
[units: participants]
  421     418     432     437     1708  
Age  
[units: Years]
Mean ( Full Range )
  65  
  ( 59 to 71 )  
  65  
  ( 60 to 72 )  
  66  
  ( 59 to 72 )  
  66  
  ( 59 to 72 )  
  65.5  
  ( 59 to 72 )  
Gender  
[units: participants]
         
Female     70     82     77     70     299  
Male     351     336     355     367     1409  



  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