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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


  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.
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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 
Overall Participants Analyzed 
[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
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Time Frame No text entered.
Additional Description 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.

Serious Adverse Events
    EDTA + High Dose Vitamin   EDTA + High Dose Vitamin Placebo   EDTA Placebo + High Dose Vitamin   EDTA Placebo + High Dose Vitamin Placebo
Total, serious adverse events         
# participants affected / at risk   2/421 (0.48%)   0/418 (0.00%)   0/432 (0.00%)   2/437 (0.46%) 
Cardiac disorders         
Cardio-respiratory arrest         
# participants affected / at risk   1/421 (0.24%)   0/418 (0.00%)   0/432 (0.00%)   0/437 (0.00%) 
# events   1   0   0   0 
Cardiac Failure Congestive         
# participants affected / at risk   0/421 (0.00%)   0/418 (0.00%)   0/432 (0.00%)   2/437 (0.46%) 
# events   0   0   0   2 
General disorders         
Malaise         
# participants affected / at risk   1/421 (0.24%)   0/418 (0.00%)   0/432 (0.00%)   0/437 (0.00%) 
# events   1   0   0   0 




  Other Adverse Events


  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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