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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
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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.

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.
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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


  Other Adverse Events
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Time Frame No text entered.
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   5  

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.

Other Adverse Events
    EDTA + High Dose Vitamin   EDTA + High Dose Vitamin Placebo   EDTA Placebo + High Dose Vitamin   EDTA Placebo + High Dose Vitamin Placebo
Total, other (not including serious) adverse events         
# participants affected / at risk   168/421 (39.90%)   201/418 (48.09%)   164/432 (37.96%)   185/437 (42.33%) 
Gastrointestinal disorders         
Diarrhoea         
# participants affected / at risk   15/421 (3.56%)   16/418 (3.83%)   23/432 (5.32%)   23/437 (5.26%) 
Nausea         
# participants affected / at risk   17/421 (4.04%)   22/418 (5.26%)   16/432 (3.70%)   19/437 (4.35%) 
Investigations         
White Blood Cell Count Decreased         
# participants affected / at risk   13/421 (3.09%)   27/418 (6.46%)   16/432 (3.70%)   19/437 (4.35%) 
Metabolism and nutrition disorders         
Hypocalcaemia         
# participants affected / at risk   63/421 (14.96%)   69/418 (16.51%)   34/432 (7.87%)   43/437 (9.84%) 
Hypoglycaemia         
# participants affected / at risk   40/421 (9.50%)   48/418 (11.48%)   49/432 (11.34%)   54/437 (12.36%) 
Renal and urinary disorders         
Proteinuria         
# participants affected / at risk   20/421 (4.75%)   19/418 (4.55%)   26/432 (6.02%)   27/437 (6.18%) 



  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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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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):


Responsible Party: Gervasio Lamas, MD, Mt. Sinai Medical Center, Miami
ClinicalTrials.gov Identifier: NCT00044213     History of Changes
Other Study ID Numbers: 654
U01HL092607 ( US NIH Grant/Contract Award Number )
U01AT001156 ( US NIH Grant/Contract Award Number )
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