Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
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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
History of Changes
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 ]

Measure Type Primary
Measure Title A Composite of Total Mortality, Recurrent Myocardial Infarction, Stroke, Coronary Revascularization, and Hospitalization for Angina.
Measure Description 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.
Time Frame Measured over a maximum 5-year follow-up period- 55 month median  
Safety Issue No  

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.

Measured Values
    EDTA + High Dose Vitamin     EDTA + High Dose Vitamin Placebo     EDTA Placebo + High Dose Vitamin     EDTA Placebo + High Dose Vitamin Placebo  
Number of Participants Analyzed  
[units: participants]
 		  421     418     432     437  
A Composite of Total Mortality, Recurrent Myocardial Infarction, Stroke, Coronary Revascularization, and Hospitalization for Angina.  
[units: participants]
 		  108     114     122     139  

No statistical analysis provided for A Composite of Total Mortality, Recurrent Myocardial Infarction, Stroke, Coronary Revascularization, and Hospitalization for Angina.



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 ]

Measure Type Secondary
Measure Title A Composite of Cardiovascular Death, Non-fatal Myocardial Infarction and Non-fatal Stroke.
Measure Description 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.
Time Frame Measured over a maximum 5-year follow-up period- 55 month median  
Safety Issue No  

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.

Measured Values
    EDTA + High Dose Vitamin     EDTA + High Dose Vitamin Placebo     EDTA Placebo + High Dose Vitamin     EDTA Placebo + High Dose Vitamin Placebo  
Number of Participants Analyzed  
[units: participants]
 		  421     418     432     437  
A Composite of Cardiovascular Death, Non-fatal Myocardial Infarction and Non-fatal Stroke.  
[units: participants]
 		  39     57     55     58  

No statistical analysis provided for A Composite of Cardiovascular Death, Non-fatal Myocardial Infarction and Non-fatal Stroke.




  Serious Adverse Events
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  Other Adverse Events
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  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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