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Chelating Agent

EDTA + high dose vitamin for Coronary Artery Disease

Phase 3
Waitlist Available
Research Sponsored by Mt. Sinai Medical Center, Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Heart attack at least 6 weeks prior to study start
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured over a maximum 5-year follow-up period- 55 month median
Awards & highlights
Pivotal Trial

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured over a maximum 5-year follow-up period- 55 month median
This trial's timeline: 3 weeks for screening, Varies for treatment, and measured over a maximum 5-year follow-up period- 55 month median for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
A Composite of Total Mortality, Recurrent Myocardial Infarction, Stroke, Coronary Revascularization, and Hospitalization for Angina.
Secondary study objectives
Myocardial Infarction

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

4Treatment groups
Active Control
Placebo Group
Group I: EDTA + high dose vitaminActive Control2 Interventions
Participants will receive 40 infusions of active EDTA chelation and active high-dose oral vitamins.
Group II: EDTA + high dose vitamin placeboPlacebo Group2 Interventions
Participants will receive 40 infusions of EDTA chelation and placebo high-dose oral vitamins.
Group III: EDTA placebo + high dose vitaminPlacebo Group2 Interventions
Participants will receive 40 infusions of placebo EDTA chelation and active high-dose oral vitamins.
Group IV: EDTA placebo + high dose vitamin placeboPlacebo Group2 Interventions
Participants will receive 40 infusions of placebo EDTA chelation and placebo high-dose oral vitamins.

Find a Location

Who is running the clinical trial?

Mt. Sinai Medical Center, MiamiLead Sponsor
18 Previous Clinical Trials
2,382 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,905 Previous Clinical Trials
47,835,949 Total Patients Enrolled
166 Trials studying Coronary Artery Disease
267,496 Patients Enrolled for Coronary Artery Disease
National Center for Complementary and Integrative Health (NCCIH)NIH
848 Previous Clinical Trials
671,208 Total Patients Enrolled
3 Trials studying Coronary Artery Disease
323 Patients Enrolled for Coronary Artery Disease
~77 spots leftby Oct 2025
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