Phase 3
Completed N=1,708
Trial to Assess Chelation Therapy (TACT)
Source: ClinicalTrials.gov NCT00044213 ↗Enrolled (actual)
1,708
Serious AEs
0.2%
Results posted
Nov 2013
Primary outcomePrimary: A Composite of Total Mortality, Recurrent Myocardial Infarction, Stroke, Coronary Revascularization, and Hospitalization for Angina. — 108; 114; 122; 139 participants
Summary
The purpose of this study is to determine the safety and effectiveness of ethylene diamine tetra-acetic (EDTA) chelation therapy in individuals with coronary artery disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY A Composite of Total Mortality, Recurrent Myocardial Infarction, Stroke, Coronary Revascularization, and Hospitalization for Angina. |
108; 114; 122; 139 | — |
| SECONDARY A Composite of Cardiovascular Death, Non-fatal Myocardial Infarction and Non-fatal Stroke. |
39; 57; 55; 58 | — |
Eligibility Criteria
Inclusion Criteria for Participants:
- Heart attack at least 6 weeks prior to study start
Exclusion Criteria for Participants:
- Serum creatinie level greater than 2.0 mg/dL
- Platelet count less than 100,000/µL
- Blood pressure greater than 160/100
- Chelation therapy within 5 years prior to study start
- History of allergic reactions to EDTA or any of the therapy's components
- Coronary or carotid revascularization procedures within 6 months prior to study start or a scheduled revascularization
- Cigarette smoking within 3 months prior to study start
- Childbearing potential
- History of liver disease
- Active heart failure or heart failure hospitalization within 6 months.
- Diagnoses of additional medical conditions that could otherwise limit patient survival
- Inability to tolerate 500-mL infusions weekly.
Data sourced from ClinicalTrials.gov (NCT00044213). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.