DiabetesPhase 3TACT2NCT02733185

Trial to Assess Chelation Therapy 2

A Phase 3 study testing disodium EDTA and Oral Multi Vitamins/Minerals (OMVM) in people with Diabetes and Myocardial Infarction, run by Mt. Sinai Medical Center, Miami at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Trial to Assess Chelation Therapy 2 (TACT2) is a randomized, double blind controlled factorial clinical trial of edetate disodium-based chelation and high-dose oral vitamins and minerals to prevent recurrent cardiac events in diabetic patients with a prior myocardial infarction (MI). Read more about this study

Who is it for?: Ages 50 years and older
Conditions the study is for: Diabetes, Myocardial Infarction
What is being tested?: disodium EDTA and Oral Multi Vitamins/Minerals (OMVM)
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,000 participants
Where: 1 siteUnited States
Study dates: 1 Oct 2016to 30 Jun 2023
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age: ≥ 50 years
History of diabetes, defined as medical record evidence or patient report of currently using insulin or oral hypoglycemic agents, or with a history of fasting blood glucose measurement of 126 mg/dL or higher, or a history of HbA1c of 6.5% or higher.
History of myocardial infarction based on the Universal Definition of MI.
When information about the MI hospitalization is available, all MI types except Type 2 qualify for study entry.
When information about the MI hospitalization is not available, a wall motion abnormality on imaging or a perfusion defect on scan that corresponds to a coronary distribution, whether or not accompanied by pathological Q waves in the appropriate distribution, will qualify the patient for study entry. This criterion requires a call to the CCC for case review.

Who cannot join

Baseline serum creatinine >2.0 mg/dL.
HbA1C >11%.
Myocardial infarction within 6 weeks of randomization.
History of allergic reactions to EDTA or any other components of the chelation solution, including heparin. Site personnel are to call the CCC to discuss heparin allergy.
Coronary or peripheral arterial revascularization procedure performed within the last 6 months.
Planned revascularization procedure in the 6 months following enrollment.

Show all 18Show fewer

Heart failure hospitalization within 6 months prior to enrollment or in clinical heart failure at the time of proposed enrollment (such as NYHA Class 3 dyspnea + rales >basilar, and additional signs of fluid overload). Such patients may be treated with diuretics and enrolled when stable.
Poor or no venous access in the upper extremities.
a. Prior intravenous chelation therapy consisting of > 1 infusion within 5 years; if only 1 infusion took place, patient cannot be enrolled for at least 12 months after said infusion.
Oral chelation therapy with an approved oral chelating agent within 2 years.
Prior participation in TACT.
Baseline platelet count <100,000.
History of cigarette smoking within the last 3 months.
ALT or AST > 2.0 times the upper limit of normal.
Wilson's disease, hemochromatosis, or parathyroid disease.
Any medical condition including a current diagnosis of cancer (except non-melanoma skin cancer) that will limit patient survival over the duration of the trial.
Any factor that suggests that the potential participant will not be able to adhere to the protocol.
Women of child-bearing potential including those with plans for post-menopausal in vitro fertilization or other reproductive technology.

Trial locations and contacts

1 site in 1 country.

United States1 site

Mount Sinai Medical Center
Miami Beach, Florida, 33132

Other trials in United States

About this study

Read the detailed description

The primary objective of TACT2, therefore, is to determine if the chelation-based strategy increases the time to the first occurrence of any of the components of the TACT2 primary endpoint: all-cause mortality, myocardial infarction, stroke, coronary revascularization, or hospitalization for unstable angina compared to the placebo chelation strategy.

TACT2 is a 2x2 factorial trial testing 40-weekly edetate disodium-based chelation infusions and twice daily high-dose oral multivitamins and multiminerals (OMVM) in a placebo-controlled design.

TACT2 is being carried out to replicate the findings of TACT1, which found a striking reduction of recurrent cardiovascular events in post-MI diabetic patients receiving edetate disodium-based chelation therapy.

Conditions: Diabetes, Myocardial Infarction
Being tested: disodium EDTA, Oral Multi Vitamins/Minerals (OMVM), Placebo disodium EDTA, Placebo Oral Multi Vitamins/Minerals (OMVM)
Keywords: chelation
Medical subject headings: Diabetes Mellitus, Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

disodium EDTADrug
Also called EDTA
IV Disodium Ethylene diamine tetra acetic acid in 500 cc
Oral Multi Vitamins/Minerals (OMVM)Dietary supplement
6 tablets of Multi-vitamin/Multimineral daily
Placebo disodium EDTADrug
IV Placebo comparator- 500 normal saline
Placebo Oral Multi Vitamins/Minerals (OMVM)Dietary supplement
6 tablets of a placebo Multi-vitamin/Multimineral daily

Study groups in NCT02733185
Study group	Role	What they receive
Active/Active	Active comparator	Active disodium EDTA (chelation) + Active Oral Multi Vitamins/Minerals (OMVM) Receives: Drug: disodium EDTA; Dietary Supplement: Oral Multi Vitamins/Minerals (OMVM)
Active/Placebo	Active comparator	Active disodium EDTA (chelation) + Placebo Oral Multi Vitamins/Minerals (OMVM) Receives: Drug: disodium EDTA
Placebo/ Active	Active comparator	Placebo disodium EDTA (chelation) + Active Oral Multi Vitamins/Minerals (OMVM) Receives: Dietary Supplement: Oral Multi Vitamins/Minerals (OMVM); Drug: Placebo disodium EDTA
Placebo/Placebo	Placebo comparator	Placebo disodium EDTA (chelation) + Placebo Oral Multi Vitamins/Minerals (OMVM) Receives: Drug: Placebo disodium EDTA; Dietary Supplement: Placebo Oral Multi Vitamins/Minerals (OMVM)

What is being measured

The primary outcome is the main question the study is designed to answer.

Primary Composite Outcome
Time to first event: myocardial infarction, stroke, hospitalization for unstable angina, coronary revascularization, or death from any cause
Measured: 48 month follow-up (median)

Secondary outcomes (2)

Secondary Composite Outcome
Time to first event: myocardial infarction, stroke, or death from cardiovascular causes
Measured: 48 month follow-up (median)
Secondary Outcome
Time to All-Cause mortality
Measured: All-Cause Mortality was assessed through study completion, up to 48 months (median)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Oct 201630 Jun 2023

First posted11 Apr 2016 (estimated)
Study start1 Oct 2016
Primary completion30 Jun 2023
Study completion30 Jun 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (8)Papers the sponsor has linked to this study.
Other trials for DiabetesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Factorial
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 1,000 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02733185
Sponsor's protocol ID: AT009149-01
Other IDs: UH3AT009149, UH3AT009150, R01AT009273, U24AT009150
Acronym: TACT2
Status last verified: Mar 2025
First submitted: 5 Apr 2016
Last updated: 30 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Lamas GA, Goertz C, Boineau R, Mark DB, Rozema T, Nahin RL, Lindblad L, Lewis EF, Drisko J, Lee KL; TACT Investigators. Effect of disodium EDTA chelation regimen on cardiovascular events in patients with previous myocardial infarction: the TACT randomized trial. JAMA. 2013 Mar 27;309(12):1241-50. doi: 10.1001/jama.2013.2107.
PubMed 23532240
Escolar E, Lamas GA, Mark DB, Boineau R, Goertz C, Rosenberg Y, Nahin RL, Ouyang P, Rozema T, Magaziner A, Nahas R, Lewis EF, Lindblad L, Lee KL. The effect of an EDTA-based chelation regimen on patients with diabetes mellitus and prior myocardial infarction in the Trial to Assess Chelation Therapy (TACT). Circ Cardiovasc Qual Outcomes. 2014 Jan;7(1):15-24. doi: 10.1161/CIRCOUTCOMES.113.000663. Epub 2013 Nov 19.
PubMed 24254885
Lamas GA, Boineau R, Goertz C, Mark DB, Rosenberg Y, Stylianou M, Rozema T, Nahin RL, Terry Chappell L, Lindblad L, Lewis EF, Drisko J, Lee KL. EDTA chelation therapy alone and in combination with oral high-dose multivitamins and minerals for coronary disease: The factorial group results of the Trial to Assess Chelation Therapy. Am Heart J. 2014 Jul;168(1):37-44.e5. doi: 10.1016/j.ahj.2014.02.012. Epub 2014 Apr 2.
PubMed 24952858
Lamas GA, Goertz C, Boineau R, Mark DB, Rozema T, Nahin RL, Drisko JA, Lee KL. Design of the Trial to Assess Chelation Therapy (TACT). Am Heart J. 2012 Jan;163(1):7-12. doi: 10.1016/j.ahj.2011.10.002.
PubMed 22172430
Lamas GA, Anstrom KJ, Navas-Acien A, Boineau R, Kim H, Rosenberg Y, Stylianou M, Jones TLZ, Joubert BR, Santella RM, Escolar E, Aude YW, Fonseca V, Elliott T, Lewis EF, Farkouh ME, Nathan DM, Mon AC, Gosnell L, Newman JD, Mark DB; TACT2 Investigators. The trial to assess chelation therapy 2 (TACT2): Rationale and design. Am Heart J. 2022 Oct;252:1-11. doi: 10.1016/j.ahj.2022.05.013. Epub 2022 May 19.
PubMed 35598636
Navas-Acien A, Santella RM, Joubert BR, Huang Z, Lokhnygina Y, Ujueta F, Gurvich I, LoIacono NJ, Ravalli F, Ward CD, Jarrett JM, Salazar AL, Boineau R, Jones TLZ, Mark DB, Newman JD, Nathan DM, Anstrom KJ, Lamas GA. Baseline characteristics including blood and urine metal levels in the Trial to Assess Chelation Therapy 2 (TACT2). Am Heart J. 2024 Jul;273:72-82. doi: 10.1016/j.ahj.2024.04.005. Epub 2024 Apr 15.
PubMed 38621575
Ujueta F, Lamas GA, Anstrom KJ, Navas-Acien A, Boineau R, Rosenberg Y, Stylianou M, Jones TLZ, Joubert BR, Yu Q, Wen J, Nemeth H, Huang Z, Fonseca V, Nathan DM, Uwaifo G, Arenas IA, Luo L, Baker J, Visentin D, Paixao A, Schmedtje JF Jr, Mark DB; TACT2 Investigators. Multivitamins After Myocardial Infarction in Patients With Diabetes: A Randomized Clinical Trial. JAMA Intern Med. 2025 May 1;185(5):540-548. doi: 10.1001/jamainternmed.2024.8408.
PubMed 40029647
Lamas GA, Anstrom KJ, Navas-Acien A, Boineau R, Nemeth H, Huang Z, Wen J, Rosenberg Y, Stylianou M, Jones TLZ, Joubert BR, Yu Q, Santella RM, Mon AC, Ujueta F, Escolar E, Nathan DM, Fonseca VA, Aude YW, Ehrman JK, Elliott T, Prashad R, Lewis EF, Lopes RD, Farkouh ME, Elliott AM, Newman JD, Mark DB; TACT2 Investigators. Edetate Disodium-Based Chelation for Patients With a Previous Myocardial Infarction and Diabetes: TACT2 Randomized Clinical Trial. JAMA. 2024 Sep 10;332(10):794-803. doi: 10.1001/jama.2024.11463.
PubMed 39141382

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Trial to Assess Chelation Therapy 2
ClinicalTrials.gov ID: NCT02733185
Acronym / sponsor ID: TACT2 / AT009149-01
Conditions: Diabetes, Myocardial Infarction
Keywords: chelation
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,000 participants (actual)
Lead sponsor: Mt. Sinai Medical Center, MiamiUniversity, hospital or other
Collaborators: National Center for Complementary and Integrative Health (NCCIH), National Heart, Lung, and Blood Institute (NHLBI), Duke Clinical Research Institute
Study start: 1 Oct 2016 (actual)
Primary completion: 30 Jun 2023 (actual)
Study completion: 30 Jun 2023 (actual)
First posted: 11 Apr 2016 (estimated)
Results: Posted 1 Oct 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

TACT2 is a 2x2 factorial trial testing 40-weekly edetate disodium-based chelation infusions and twice daily high-dose oral multivitamins and multiminerals (OMVM) in a placebo-controlled design.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Factorial
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 4

Arm	Type	Receives
Active/Active	Active comparator	Drug: disodium EDTA, Dietary Supplement: Oral Multi Vitamins/Minerals (OMVM)Active disodium EDTA (chelation) + Active Oral Multi Vitamins/Minerals (OMVM)
Active/Placebo	Active comparator	Drug: disodium EDTAActive disodium EDTA (chelation) + Placebo Oral Multi Vitamins/Minerals (OMVM)
Placebo/ Active	Active comparator	Dietary Supplement: Oral Multi Vitamins/Minerals (OMVM), Drug: Placebo disodium EDTAPlacebo disodium EDTA (chelation) + Active Oral Multi Vitamins/Minerals (OMVM)
Placebo/Placebo	Placebo comparator	Drug: Placebo disodium EDTA, Dietary Supplement: Placebo Oral Multi Vitamins/Minerals (OMVM)Placebo disodium EDTA (chelation) + Placebo Oral Multi Vitamins/Minerals (OMVM)

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Age: ≥ 50 years
History of diabetes, defined as medical record evidence or patient report of currently using insulin or oral hypoglycemic agents, or with a history of fasting blood glucose measurement of 126 mg/dL or higher, or a history of HbA1c of 6.5% or higher.
History of myocardial infarction based on the Universal Definition of MI.

Key exclusion criteria (18 listed)

Baseline serum creatinine >2.0 mg/dL.
HbA1C >11%.
Myocardial infarction within 6 weeks of randomization.
History of allergic reactions to EDTA or any other components of the chelation solution, including heparin. Site personnel are to call the CCC to discuss heparin allergy.
Coronary or peripheral arterial revascularization procedure performed within the last 6 months.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
disodium EDTAAlso: EDTAIV Disodium Ethylene diamine tetra acetic acid in 500 cc	Drug	Active/Active, Active/Placebo
Oral Multi Vitamins/Minerals (OMVM)6 tablets of Multi-vitamin/Multimineral daily	Dietary supplement	Active/Active, Placebo/ Active
Placebo disodium EDTAIV Placebo comparator- 500 normal saline	Drug	Placebo/ Active, Placebo/Placebo
Placebo Oral Multi Vitamins/Minerals (OMVM)6 tablets of a placebo Multi-vitamin/Multimineral daily	Dietary supplement	Placebo/Placebo

Primary outcome

Primary Composite Outcome
Time frame: 48 month follow-up (median)
Time to first event: myocardial infarction, stroke, hospitalization for unstable angina, coronary revascularization, or death from any cause

2 secondary outcomes

Secondary Composite Outcome
Time frame: 48 month follow-up (median)
Secondary Outcome
Time frame: All-Cause Mortality was assessed through study completion, up to 48 months (median)

Results and safety

Results posted to the registry on 1 Oct 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Active/Active	250	175
Active/Placebo	249	187
Placebo/ Active	250	182
Placebo/Placebo	251	176

Primary outcome: Primary Composite Outcome

Time frame: 48 month follow-up (median). Count of participants. Unit: Participants

Measure	Active/Active n = 250	Active/Placebo n = 249	Placebo/ Active n = 250	Placebo/Placebo n = 251
Value	85	89	90	86

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: All adverse events were collected from randomization until 30 days after their final infusion, approximately 13 months All-Cause Mortality was assessed through study completion, up to 48 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Active EDTA/Active Vitamins	41 of 250 (16.4%)	0 of 250 (0%)	50 of 250
Active EDTA /Placebo Vitamins	40 of 249 (16.1%)	0 of 249 (0%)	36 of 249
Placebo EDTA/ Active Vitamins	40 of 250 (16%)	0 of 250 (0%)	40 of 250
Placebo EDTA/Placebo Vitamins	40 of 251 (15.9%)	0 of 251 (0%)	49 of 251

Limitations and caveats (from the sponsor): Primary analyses were restricted to a modified intention-to-treat. Treatment adherence was imperfect. 12% of participants were lost to follow-up or withdrew consent.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 23532240Lamas GA, Goertz C, Boineau R, Mark DB, Rozema T, Nahin RL, Lindblad L, Lewis EF, Drisko J, Lee KL; TACT Investigators. Effect of disodium EDTA chelation regimen on cardiovascular events in patients with previous myocardial infarction: the TACT randomized trial. JAMA. 2013 Mar 27;309(12):1241-50. doi: 10.1001/jama.2013.2107.
Background: PubMed 24254885Escolar E, Lamas GA, Mark DB, Boineau R, Goertz C, Rosenberg Y, Nahin RL, Ouyang P, Rozema T, Magaziner A, Nahas R, Lewis EF, Lindblad L, Lee KL. The effect of an EDTA-based chelation regimen on patients with diabetes mellitus and prior myocardial infarction in the Trial to Assess Chelation Therapy (TACT). Circ Cardiovasc Qual Outcomes. 2014 Jan;7(1):15-24. doi: 10.1161/CIRCOUTCOMES.113.000663. Epub 2013 Nov 19.
Background: PubMed 24952858Lamas GA, Boineau R, Goertz C, Mark DB, Rosenberg Y, Stylianou M, Rozema T, Nahin RL, Terry Chappell L, Lindblad L, Lewis EF, Drisko J, Lee KL. EDTA chelation therapy alone and in combination with oral high-dose multivitamins and minerals for coronary disease: The factorial group results of the Trial to Assess Chelation Therapy. Am Heart J. 2014 Jul;168(1):37-44.e5. doi: 10.1016/j.ahj.2014.02.012. Epub 2014 Apr 2.
Background: PubMed 22172430Lamas GA, Goertz C, Boineau R, Mark DB, Rozema T, Nahin RL, Drisko JA, Lee KL. Design of the Trial to Assess Chelation Therapy (TACT). Am Heart J. 2012 Jan;163(1):7-12. doi: 10.1016/j.ahj.2011.10.002.
Background: PubMed 35598636Lamas GA, Anstrom KJ, Navas-Acien A, Boineau R, Kim H, Rosenberg Y, Stylianou M, Jones TLZ, Joubert BR, Santella RM, Escolar E, Aude YW, Fonseca V, Elliott T, Lewis EF, Farkouh ME, Nathan DM, Mon AC, Gosnell L, Newman JD, Mark DB; TACT2 Investigators. The trial to assess chelation therapy 2 (TACT2): Rationale and design. Am Heart J. 2022 Oct;252:1-11. doi: 10.1016/j.ahj.2022.05.013. Epub 2022 May 19.
Background: PubMed 38621575Navas-Acien A, Santella RM, Joubert BR, Huang Z, Lokhnygina Y, Ujueta F, Gurvich I, LoIacono NJ, Ravalli F, Ward CD, Jarrett JM, Salazar AL, Boineau R, Jones TLZ, Mark DB, Newman JD, Nathan DM, Anstrom KJ, Lamas GA. Baseline characteristics including blood and urine metal levels in the Trial to Assess Chelation Therapy 2 (TACT2). Am Heart J. 2024 Jul;273:72-82. doi: 10.1016/j.ahj.2024.04.005. Epub 2024 Apr 15.
Derived from this study: PubMed 40029647Ujueta F, Lamas GA, Anstrom KJ, Navas-Acien A, Boineau R, Rosenberg Y, Stylianou M, Jones TLZ, Joubert BR, Yu Q, Wen J, Nemeth H, Huang Z, Fonseca V, Nathan DM, Uwaifo G, Arenas IA, Luo L, Baker J, Visentin D, Paixao A, Schmedtje JF Jr, Mark DB; TACT2 Investigators. Multivitamins After Myocardial Infarction in Patients With Diabetes: A Randomized Clinical Trial. JAMA Intern Med. 2025 May 1;185(5):540-548. doi: 10.1001/jamainternmed.2024.8408.
Derived from this study: PubMed 39141382Lamas GA, Anstrom KJ, Navas-Acien A, Boineau R, Nemeth H, Huang Z, Wen J, Rosenberg Y, Stylianou M, Jones TLZ, Joubert BR, Yu Q, Santella RM, Mon AC, Ujueta F, Escolar E, Nathan DM, Fonseca VA, Aude YW, Ehrman JK, Elliott T, Prashad R, Lewis EF, Lopes RD, Farkouh ME, Elliott AM, Newman JD, Mark DB; TACT2 Investigators. Edetate Disodium-Based Chelation for Patients With a Previous Myocardial Infarction and Diabetes: TACT2 Randomized Clinical Trial. JAMA. 2024 Sep 10;332(10):794-803. doi: 10.1001/jama.2024.11463.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Gervasio A Lamas, MD study chair

Mount Sinai Medical Center of Florida

Kevin J Anstrom, PhD principal investigator

University of North Carolina, Chapel Hill

Daniel B Mark, MD principal investigator

Duke University (Duke Clinical Research Institute)

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing disodium EDTA and Oral Multi Vitamins/Minerals (OMVM) in people with Diabetes and Myocardial Infarction, run by Mt. Sinai Medical Center, Miami at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Composite Outcome (time frame: 48 month follow-up (median)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02733185, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.