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
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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
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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
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Gervasio A. Lamas, M.D.
Organization: Mount Sinai Medical Center
phone: 305-674-2162
e-mail: Gervasio.Lamas@msmc.com


No publications provided by Mt. Sinai Medical Center, Miami

Publications automatically indexed to this study:

Responsible Party: Gervasio Lamas, MD, 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