Trial to Assess Chelation Therapy (TACT)

This study has been completed.
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 Identifier:
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

  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
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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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