Coronary Artery Disease
Conditions
Brief 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.
Detailed description
EDTA chelation therapy involves repeated administrations of a synthetic amino acid to reduce atherosclerotic plaque and other mineral deposits throughout the cardiovascular system. Participants will be randomly assigned to receive 40 infusions of either the standard chelation solution or placebo. The primary endpoint of this trial will be a composite of all cause mortality, myocardial infarction, stroke, coronary revascularization, and hospitalization for angina. The results of TACT will provide either a significant positive result or an informative null result upon which rational clinical decision-making and health policy can be based.
Interventions
DRUGEDTA
Participants will receive 40 infusions of standard chelation solution.
DRUGEDTA Placebo
Participants will receive 40 infusions of EDTA placebo.
DIETARY_SUPPLEMENTHigh Dose Vitamin
DIETARY_SUPPLEMENTHigh Dose Vitamin Placebo
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
National Center for Complementary and Integrative Health (NCCIH)
Mt. Sinai Medical Center, Miami
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| A Composite of Total Mortality, Recurrent Myocardial Infarction, Stroke, Coronary Revascularization, and Hospitalization for Angina. | Measured over a maximum 5-year follow-up period- 55 month median | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| A Composite of Cardiovascular Death, Non-fatal Myocardial Infarction and Non-fatal Stroke. | Measured over a maximum 5-year follow-up period- 55 month median | 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. |
Countries
Canada, United States
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| EDTA + High Dose Vitamin Participants will receive 40 infusions of active EDTA chelation and active high-dose oral vitamins. | 421 |
| EDTA + High Dose Vitamin Placebo Participants will receive 40 infusions of EDTA chelation and placebo high-dose oral vitamins. | 418 |
| EDTA Placebo + High Dose Vitamin Participants will receive 40 infusions of placebo EDTA chelation and active high-dose oral vitamins. | 432 |
| EDTA Placebo + High Dose Vitamin Placebo Participants will receive 40 infusions of placebo EDTA chelation and placebo high-dose oral vitamins. | 437 |
| Total | 1,708 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Death | 42 | 42 | 42 | 49 |
| Overall Study | Lost to Follow-up | 8 | 5 | 5 | 4 |
| Overall Study | Withdrawal by Subject | 50 | 65 | 91 | 83 |
Baseline characteristics
| Characteristic | EDTA + High Dose Vitamin | EDTA + High Dose Vitamin Placebo | EDTA Placebo + High Dose Vitamin | EDTA Placebo + High Dose Vitamin Placebo | Total |
|---|---|---|---|---|---|
| Age Continuous | 65 Years | 65 Years | 66 Years | 66 Years | 65.5 Years |
| Sex: Female, Male Female | 70 Participants | 82 Participants | 77 Participants | 70 Participants | 299 Participants |
| Sex: Female, Male Male | 351 Participants | 336 Participants | 355 Participants | 367 Participants | 1409 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 168 / 421 | 201 / 418 | 164 / 432 | 185 / 437 |
| serious Total, serious adverse events | 2 / 421 | 0 / 418 | 0 / 432 | 2 / 437 |
Outcome results
Primary
A Composite of Total Mortality, Recurrent Myocardial Infarction, Stroke, Coronary Revascularization, and Hospitalization for Angina.
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EDTA + High Dose Vitamin | A Composite of Total Mortality, Recurrent Myocardial Infarction, Stroke, Coronary Revascularization, and Hospitalization for Angina. | 108 participants |
| EDTA + High Dose Vitamin Placebo | A Composite of Total Mortality, Recurrent Myocardial Infarction, Stroke, Coronary Revascularization, and Hospitalization for Angina. | 114 participants |
| EDTA Placebo + High Dose Vitamin | A Composite of Total Mortality, Recurrent Myocardial Infarction, Stroke, Coronary Revascularization, and Hospitalization for Angina. | 122 participants |
| EDTA Placebo + High Dose Vitamin Placebo | A Composite of Total Mortality, Recurrent Myocardial Infarction, Stroke, Coronary Revascularization, and Hospitalization for Angina. | 139 participants |
Secondary
A Composite of Cardiovascular Death, Non-fatal Myocardial Infarction and Non-fatal Stroke.
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EDTA + High Dose Vitamin | A Composite of Cardiovascular Death, Non-fatal Myocardial Infarction and Non-fatal Stroke. | 39 participants |
| EDTA + High Dose Vitamin Placebo | A Composite of Cardiovascular Death, Non-fatal Myocardial Infarction and Non-fatal Stroke. | 57 participants |
| EDTA Placebo + High Dose Vitamin | A Composite of Cardiovascular Death, Non-fatal Myocardial Infarction and Non-fatal Stroke. | 55 participants |
| EDTA Placebo + High Dose Vitamin Placebo | A Composite of Cardiovascular Death, Non-fatal Myocardial Infarction and Non-fatal Stroke. | 58 participants |