ClinicalTrials.gov
ClinicalTrials.gov Menu

Trial to Assess Chelation Therapy (TACT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00044213
Recruitment Status : Completed
First Posted : August 23, 2002
Results First Posted : November 5, 2013
Last Update Posted : November 5, 2013
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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Double (Participant, 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
Enrollment 1708
Recruitment Details 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  
Arm/Group Title EDTA + High Dose Vitamin EDTA + High Dose Vitamin Placebo EDTA Placebo + High Dose Vitamin EDTA Placebo + High Dose Vitamin Placebo
Hide Arm/Group Description Participants will receive 40 infusions of active EDTA chelation and active high-dose oral vitamins. Participants will receive 40 infusions of EDTA chelation and placebo high-dose oral vitamins. Participants will receive 40 infusions of placebo EDTA chelation and active high-dose oral vitamins. Participants will receive 40 infusions of placebo EDTA chelation and placebo high-dose oral vitamins.
Period Title: Overall Study
Started 421 418 432 437
Completed 321 306 294 301
Not Completed 100 112 138 136
Reason Not Completed
Withdrawal by Subject             50             65             91             83
Death             42             42             42             49
Lost to Follow-up             8             5             5             4
Arm/Group Title EDTA + High Dose Vitamin EDTA + High Dose Vitamin Placebo EDTA Placebo + High Dose Vitamin EDTA Placebo + High Dose Vitamin Placebo Total
Hide Arm/Group Description Participants will receive 40 infusions of active EDTA chelation and active high-dose oral vitamins. Participants will receive 40 infusions of EDTA chelation and placebo high-dose oral vitamins. Participants will receive 40 infusions of placebo EDTA chelation and active high-dose oral vitamins. Participants will receive 40 infusions of placebo EDTA chelation and placebo high-dose oral vitamins. Total of all reporting groups
Overall Number of Baseline Participants 421 418 432 437 1708
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 421 participants 418 participants 432 participants 437 participants 1708 participants
65
(59 to 71)
65
(60 to 72)
66
(59 to 72)
66
(59 to 72)
65.5
(59 to 72)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 421 participants 418 participants 432 participants 437 participants 1708 participants
Female
70
  16.6%
82
  19.6%
77
  17.8%
70
  16.0%
299
  17.5%
Male
351
  83.4%
336
  80.4%
355
  82.2%
367
  84.0%
1409
  82.5%
1.Primary Outcome
Title A Composite of Total Mortality, Recurrent Myocardial Infarction, Stroke, Coronary Revascularization, and Hospitalization for Angina.
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title EDTA + High Dose Vitamin EDTA + High Dose Vitamin Placebo EDTA Placebo + High Dose Vitamin EDTA Placebo + High Dose Vitamin Placebo
Hide Arm/Group Description:
Participants will receive 40 infusions of active EDTA chelation and active high-dose oral vitamins.
Participants will receive 40 infusions of EDTA chelation and placebo high-dose oral vitamins.
Participants will receive 40 infusions of placebo EDTA chelation and active high-dose oral vitamins.
Participants will receive 40 infusions of placebo EDTA chelation and placebo high-dose oral vitamins.
Overall Number of Participants Analyzed 421 418 432 437
Measure Type: Number
Unit of Measure: participants
108 114 122 139
2.Secondary Outcome
Title A Composite of Cardiovascular Death, Non-fatal Myocardial Infarction and Non-fatal Stroke.
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title EDTA + High Dose Vitamin EDTA + High Dose Vitamin Placebo EDTA Placebo + High Dose Vitamin EDTA Placebo + High Dose Vitamin Placebo
Hide Arm/Group Description:
Participants will receive 40 infusions of active EDTA chelation and active high-dose oral vitamins.
Participants will receive 40 infusions of EDTA chelation and placebo high-dose oral vitamins.
Participants will receive 40 infusions of placebo EDTA chelation and active high-dose oral vitamins.
Participants will receive 40 infusions of placebo EDTA chelation and placebo high-dose oral vitamins.
Overall Number of Participants Analyzed 421 418 432 437
Measure Type: Number
Unit of Measure: participants
39 57 55 58
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title EDTA + High Dose Vitamin EDTA + High Dose Vitamin Placebo EDTA Placebo + High Dose Vitamin EDTA Placebo + High Dose Vitamin Placebo
Hide Arm/Group Description Participants will receive 40 infusions of active EDTA chelation and active high-dose oral vitamins. Participants will receive 40 infusions of EDTA chelation and placebo high-dose oral vitamins. Participants will receive 40 infusions of placebo EDTA chelation and active high-dose oral vitamins. Participants will receive 40 infusions of placebo EDTA chelation and placebo high-dose oral vitamins.
All-Cause Mortality
EDTA + High Dose Vitamin EDTA + High Dose Vitamin Placebo EDTA Placebo + High Dose Vitamin EDTA Placebo + High Dose Vitamin Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
EDTA + High Dose Vitamin EDTA + High Dose Vitamin Placebo EDTA Placebo + High Dose Vitamin EDTA Placebo + High Dose Vitamin Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/421 (0.48%)      0/418 (0.00%)      0/432 (0.00%)      2/437 (0.46%)    
Cardiac disorders         
Cardio-respiratory arrest  1/421 (0.24%)  1 0/418 (0.00%)  0 0/432 (0.00%)  0 0/437 (0.00%)  0
Cardiac Failure Congestive  0/421 (0.00%)  0 0/418 (0.00%)  0 0/432 (0.00%)  0 2/437 (0.46%)  2
General disorders         
Malaise  1/421 (0.24%)  1 0/418 (0.00%)  0 0/432 (0.00%)  0 0/437 (0.00%)  0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
EDTA + High Dose Vitamin EDTA + High Dose Vitamin Placebo EDTA Placebo + High Dose Vitamin EDTA Placebo + High Dose Vitamin Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   168/421 (39.90%)      201/418 (48.09%)      164/432 (37.96%)      185/437 (42.33%)    
Gastrointestinal disorders         
Diarrhoea  15/421 (3.56%)  16/418 (3.83%)  23/432 (5.32%)  23/437 (5.26%) 
Nausea  17/421 (4.04%)  22/418 (5.26%)  16/432 (3.70%)  19/437 (4.35%) 
Investigations         
White Blood Cell Count Decreased  13/421 (3.09%)  27/418 (6.46%)  16/432 (3.70%)  19/437 (4.35%) 
Metabolism and nutrition disorders         
Hypocalcaemia  63/421 (14.96%)  69/418 (16.51%)  34/432 (7.87%)  43/437 (9.84%) 
Hypoglycaemia  40/421 (9.50%)  48/418 (11.48%)  49/432 (11.34%)  54/437 (12.36%) 
Renal and urinary disorders         
Proteinuria  20/421 (4.75%)  19/418 (4.55%)  26/432 (6.02%)  27/437 (6.18%) 
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.
Enrolling Centers must abide by all TACT and NIH conflict of interest policies. Decisions about authorship on all multi-center publications resulting from research under this agreement will be made by the TACT Publica¬tions Committee prior to publication. No publications or other public disclosure shall be made until the TACT results are unblinded and results from all sites have been received and analyzed or TACT has been abandoned at all sites.
Results Point of Contact
Name/Title: Gervasio A. Lamas, M.D.
Organization: Mount Sinai Medical Center
Phone: 305-674-2162
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 ( U.S. NIH Grant/Contract )
U01AT001156 ( U.S. NIH Grant/Contract )
First Submitted: August 22, 2002
First Posted: August 23, 2002
Results First Submitted: August 30, 2013
Results First Posted: November 5, 2013
Last Update Posted: November 5, 2013