Trial · NCT00044213
Trial to Assess Chelation Therapy (TACT)
NCT00044213, Phase 3, Completed, Mt. Sinai Medical Center, Miami; results first posted 2013-11-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Trial to Assess Chelation Therapy (TACT). Trials, record NCT00044213. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00044213
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trial to Assess Chelation Therapy (TACT)
- NCT number
- NCT00044213
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,708 participants, actual
- Lead sponsor
- Mt. Sinai Medical Center, Miami
- Conditions
- Coronary Artery Disease
- Interventions
- EDTA, EDTA Placebo, High Dose Vitamin, High Dose Vitamin Placebo
- First posted
- 2002-08-23
- Last updated
- 2013-11-05
- Results first posted
- 2013-11-05
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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 | participants | NUMBER | |
| SECONDARY | 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 | participants | NUMBER |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| A Composite of Total Mortality, Recurrent Myocardial Infarction, Stroke, Coronary Revascularization, and Hospitalization for Angina. | EDTA + High Dose Vitamin | 108 | participants | ||
| A Composite of Total Mortality, Recurrent Myocardial Infarction, Stroke, Coronary Revascularization, and Hospitalization for Angina. | EDTA + High Dose Vitamin Placebo | 114 | participants | ||
| A Composite of Total Mortality, Recurrent Myocardial Infarction, Stroke, Coronary Revascularization, and Hospitalization for Angina. | EDTA Placebo + High Dose Vitamin | 122 | participants | ||
| A Composite of Total Mortality, Recurrent Myocardial Infarction, Stroke, Coronary Revascularization, and Hospitalization for Angina. | EDTA Placebo + High Dose Vitamin Placebo | 139 | participants | ||
| A Composite of Cardiovascular Death, Non-fatal Myocardial Infarction and Non-fatal Stroke. | EDTA + High Dose Vitamin | 39 | participants | ||
| A Composite of Cardiovascular Death, Non-fatal Myocardial Infarction and Non-fatal Stroke. | EDTA + High Dose Vitamin Placebo | 57 | participants | ||
| A Composite of Cardiovascular Death, Non-fatal Myocardial Infarction and Non-fatal Stroke. | EDTA Placebo + High Dose Vitamin | 55 | participants | ||
| A Composite of Cardiovascular Death, Non-fatal Myocardial Infarction and Non-fatal Stroke. | EDTA Placebo + High Dose Vitamin Placebo | 58 | participants |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | EDTA + High Dose Vitamin | 421 | |
| Overall Study | STARTED | EDTA + High Dose Vitamin Placebo | 418 | |
| Overall Study | STARTED | EDTA Placebo + High Dose Vitamin | 432 | |
| Overall Study | STARTED | EDTA Placebo + High Dose Vitamin Placebo | 437 | |
| Overall Study | COMPLETED | EDTA + High Dose Vitamin | 321 | |
| Overall Study | COMPLETED | EDTA + High Dose Vitamin Placebo | 306 | |
| Overall Study | COMPLETED | EDTA Placebo + High Dose Vitamin | 294 | |
| Overall Study | COMPLETED | EDTA Placebo + High Dose Vitamin Placebo | 301 | |
| Overall Study | NOT COMPLETED | EDTA + High Dose Vitamin | 100 | |
| Overall Study | NOT COMPLETED | EDTA + High Dose Vitamin Placebo | 112 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events36
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | EDTA + High Dose Vitamin | 15 | 421 | |
| other | Diarrhoea | Gastrointestinal disorders | EDTA + High Dose Vitamin Placebo | 16 | 418 | |
| other | Diarrhoea | Gastrointestinal disorders | EDTA Placebo + High Dose Vitamin | 23 | 432 | |
| other | Diarrhoea | Gastrointestinal disorders | EDTA Placebo + High Dose Vitamin Placebo | 23 | 437 | |
| other | Nausea | Gastrointestinal disorders | EDTA + High Dose Vitamin | 17 | 421 | |
| other | Nausea | Gastrointestinal disorders | EDTA + High Dose Vitamin Placebo | 22 | 418 | |
| other | Nausea | Gastrointestinal disorders | EDTA Placebo + High Dose Vitamin | 16 | 432 | |
| other | Nausea | Gastrointestinal disorders | EDTA Placebo + High Dose Vitamin Placebo | 19 | 437 | |
| other | White Blood Cell Count Decreased | Investigations | EDTA + High Dose Vitamin | 13 | 421 | |
| other | White Blood Cell Count Decreased | Investigations | EDTA + High Dose Vitamin Placebo | 27 | 418 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | EDTA + High Dose Vitamin | ||
| Total, all-cause mortality | EDTA + High Dose Vitamin Placebo | ||
| Total, all-cause mortality | EDTA Placebo + High Dose Vitamin | ||
| Total, all-cause mortality | EDTA Placebo + High Dose Vitamin Placebo | ||
| Total, other adverse events | EDTA + High Dose Vitamin | 168 | 421 |
| Total, other adverse events | EDTA + High Dose Vitamin Placebo | 201 | 418 |
| Total, other adverse events | EDTA Placebo + High Dose Vitamin | 164 | 432 |
| Total, other adverse events | EDTA Placebo + High Dose Vitamin Placebo | 185 | 437 |
| Total, serious adverse events | EDTA + High Dose Vitamin | 2 | 421 |
| Total, serious adverse events | EDTA + High Dose Vitamin Placebo | 0 | 418 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers6
The papers the trial lists on ClinicalTrials.gov.
Grants2
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| U01HL092607 | Trial to Assess Chelation Therapy (TACT) | LAMAS, GERVASIO A | MOUNT SINAI MEDICAL CENTER (MIAMI BEACH) | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE | 2007 to 2012 | NIH RePORTER |
| U01AT001156 | Trial to Assess Chelation Therapy (TACT) | LAMAS, GERVASIO A | MOUNT SINAI MEDICAL CENTER (MIAMI BEACH) | NATIONAL CENTER FOR COMPLEMENTARY &ALTERNATIVE MEDICINE | 2002 to 2004 | NIH RePORTER |
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00044213
GET https://conductscience.org/api/trials/v1/NCT00044213/events?page=2