Acute Myocardial InfarctionPhase 4PRESTIGE-AMINCT04899479
Peri-treatment of SGLT-2 Inhibitor on Myocardial Infarct Size and Remodeling Index in Patients With Acute Myocardial Infarction and High Risk of Heart Failure Undergoing Percutaneous Coronary Intervention
A Phase 4 study testing SGLT2 inhibitor in people with Acute Myocardial Infarction and Heart Failure, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
We aimed to identify whether SGLT-2 inhibitor administration before and after coronary intervention is effective in reducing the size of infarction and myocardial remodeling in patients with acute myocardial infarction (AMI) and high risk of heart failure, and its mechanism. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myocardial Infarction, Heart Failure
- What is being tested?
- SGLT2 inhibitor
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteSouth Korea
- Study dates
- 5 Jul 2021to 30 Dec 2025
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1) Subject must be at least 18 years of age 2) Subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of receiving SGLT-2 inhibitor and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure 3) Diagnosis of Type 1 myocardial infarction (MI) (ST-segment elevation MI [STEMI] or Non-ST-segment elevation MI [NSTEMI]) i) Detection of a rise and/or fall of cardiac troponin values with at least 1 value above the 99th percentile upper reference limit ii) Symptoms or electrocardiographic changes suggesting myocardial ischemia 4) High risk of heart failure (at least one of the two criteria below are met) i) Left ventricular ejection fraction < 50% ii) Symptoms or signs of pulmonary congestion requiring treatment
Who cannot join
- 1) Target lesion is not suitable for PCI by operator's decision 2) Patients requiring cardiopulmonary resuscitation due to cardiac arrest before randomization 3) Rescue PCI after thrombolysis or facilitated PCI 4) Previous MI 5) Previous history of heart failure 6) Patients who have been taking SGLT-2 inhibitor 7) Patients with glomerular filtration rate < 30ml/min/1.73m2 or on dialysis 8) Type 1 diabetes mellitus (DM) 9) Known hypersensitivity or contraindications to study medications (SGLT-2 inhibitor) 10) Pregnant or lactating women 11) Non-cardiac co-morbid conditions are present with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul
Ki Hong Choi, MD, 82-2-3410-3419, cardiokh@gmail.com
About this study
Official title: Peri-tREatment of SGLT-2 Inhibitor on Myocardial Infarct Size and Remodeling Index Measured by Cardiac maGnetic rEsonance Imaging in Patients With Acute Myocardial Infarction and High Risk of Heart Failure Undergoing Percutaneous Coronary Intervention
We aimed to identify whether SGLT-2 inhibitor administration before and after coronary intervention is effective in reducing the size of infarction and myocardial remodeling in patients with acute myocardial infarction (AMI) and high risk of heart failure, and its mechanism. For this reason, we compared cardiac magnetic resonance imaging (CMR) parameters and clinical outcomes between the SGLT-2 inhibitor group and the control group to confirm the efficacy and safety of SGLT-2 inhibitors.
Read the detailed description
After the introduction of percutaneous coronary intervention (PCI) as a method to normalize blood flow in the treatment of coronary artery disease, not only the technical aspects of coronary intervention but also the devices and medications have been improved over the past 30 years. However, despite these advances, morbidity, and mortality of AMI are still high. In particular, in patients with ST-segment elevation MI (STEMI), the 1-year mortality rate and hospitalization rate due to heart failure are 10%, and 22%, respectively. Accordingly, various efforts are being made to improve the prognosis of AMI and to reduce the infarct size, which is a major prognostic factor. The most effective method for achieving this goal to early and successful revascularization by PCI. However, restoring blood flow, which is a prerequisite for relieving ischemia, can paradoxically cause damage to the myocardium and death of the myocardium by itself. This phenomenon is called myocardial reperfusion injury. Several pharmacological and mechanical treatments targeting this phenomenon have been studied, and the experimental and small-scale clinical trials have been shown to have the effect of reducing infarct size and relieving myocardium.4 However, to date, large-scale clinical trials have not demonstrated clinical benefits.
SGLT-2 inhibitors are developed to lower blood sugar and treat type 2 diabetes mellitus (DM) by inhibiting Sodium glucose co-transporter-2 in proximal renal tubule, releasing glucose into the urine and preventing reabsorption. However, SGLT-2 inhibitors are known to have an effect on lowering cardiovascular events in addition to lowering blood sugar. In three large-scale, multicenter, randomized trials to evaluate the effects of SGLT-2 in type 2 diabetic patients, the combined outcome consisting of cardiac death or readmission due to heart failure was significantly lowered compared to the placebo group. In particular, DECLARE-TIMI 58 trial confirmed that this effect was consistent regardless of the history of atherosclerotic cardiovascular disease or heart failure.8 In addition, DAPA-CKD trial showed that SGLT-2 inhibitor significantly reduced the composite outcome consisting of cardiovascular death or readmission due to heart failure as well as the kidney-related outcome compared to the placebo group in patients with chronic kidney disease regardless of type 2 DM. Similarly, EMPEROR-Reduced and DAPA-HF trials consistently demonstrated that SGLT-2 inhibitor was associated with significantly lower risk of a composite of cardiovascular death or worsening heart failure in patients with heart failure with reduced ejection fraction. Therefore, the current guideline recommended the use of SGLT-2 inhibitor in patients with heart failure with reduced ejection fraction, with a conjunction of goal-directed medical therapy. Nevertheless, the mechanism that can explain this has been extensively investigated, but it is not clear yet. Several potential hypotheses have been proposed as mechanisms such as increased natriuresis, decreased blood pressure, decreased inflammation, and decreased reactive oxidative stress. In this regard, it is anticipated that the use of SGLT-2 inhibitors will benefit even in patients with AMI and high risk of heart failure in both acute and chronic phases.
Therefore, we aimed to identify whether SGLT-2 inhibitor administration before and after coronary intervention is effective in reducing the size of infarction and myocardial remodeling in patients with AMI and high risk of heart failure, and its mechanism. For this reason, we compared CMR parameters and clinical outcomes between the SGLT-2 inhibitor group and the control group to confirm the efficacy and safety of SGLT-2 inhibitors.
- Conditions
- Acute Myocardial Infarction, Heart Failure
- Being tested
- SGLT2 inhibitor, Control
- Keywords
- Percutaneous Coronary Intervention, Infarct size, Cardiac Magnetic Resonance Imaging
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SGLT2 inhibitorDrug
In patients with AMI and high risk of heart failure, 1:1 randomization will be performed to either SGLT2 inhibitor or control group.
ControlOther
In patients with AMI and high risk of heart failure, 1:1 randomization will be performed to either SGLT2 inhibitor or control group.
| Study group | Role | What they receive |
|---|---|---|
| SGLT-2 inhibitor | Experimental | The SGLT-2 inhibitor group will receive SGLT-2 inhibitor once daily until the end of the study period. Receives: Drug: SGLT2 inhibitor |
| Control | Placebo comparator | The control group will not receive any additional drugs. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial infract size (IS)
IS measured using CMR
Measured: at 6-month follow-up
∆Left ventricular end-systolic volume
Difference of left ventricular end-systolic volume measured by CMR
Measured: Between index hospitalization and 6-month follow-up
Secondary outcomes (20)
Acute kidney injury
According to KDIGO guideline
Measured: Within 3 days after index PCI
Myocardial IS
IS measured using CMR
Measured: Within 3 days after index PCI
Microvascular obstruction (MVO)
MVO measured using CMR
Measured: Within 3 days after index PCI
IS
measured by peak cardiac enzyme
Measured: Within 3 days after index PCI
∆left ventricular end-diastolic volume
Difference of left ventricular end-diastolic volume measured using CMR
Measured: Between index hospitalization and 6-month follow-up
∆left ventricular ejection fraction
Difference of left ventricular ejection fraction measured using CMR
Measured: Between index hospitalization and 6-month follow-up
LV adverse remodeling
measured by CMR
Measured: Between index hospitalization and 6-month follow-up
LV reverse remodeling
measured by CMR
Measured: Between index hospitalization and 6-month follow-up
MVO
measured using CMR
Measured: at 6-month follow-up
Changes of NT-proBNP level
Difference of NT-proBNP
Measured: Between index hospitalization and 6-month follow-up
Estimated glomerular filtration rate
Kidney function
Measured: 6 months after index PCI
Cardiovascular death, myocardial infarction, cerebrovascular events, stent thrombosis, and re-hospitalization due to cardiac cause
MACE
Measured: 12 months after index PCI
Cardiovascular death, or re-hospitalization due to cardiac cause
cardiovascular death or re-hospitalization due to cardiac cause
Measured: 12 months after index PCI
All-cause death
All-cause death during follow-up
Measured: 12 months after index PCI
Cardiovascular death
Cardiovascular death during follow-up
Measured: 12 months after index PCI
MI
MI during follow-up
Measured: 12 months after index PCI
Repeat revascularization
Repeat revascularization during follow-up
Measured: 12 months after index PCI
Re-hospitalization due to heart failure
Re-hospitalization due to heart failure during follow-up
Measured: 12 months after index PCI
Re-hospitalization due to cardiac cause
Re-hospitalization due to cardiac cause during follow-up
Measured: 12 months after index PCI
Cerebrovascular events
ischemic or hemorrhagic stroke during follow-up
Measured: 12 months after index PCI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2021
- Study start5 Jul 2021
- Primary completion31 Aug 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization will be performed 1:1 between SGLT-2 inhibitor and control. Stratification will be done by DM and clinical presentation (STEMI vs. NSTEMI).
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Young Bin Song, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04899479
- Sponsor's protocol ID
- PRESTIGE-AMI
- Acronym
- PRESTIGE-AMI
- Status last verified
- Jun 2025
- First submitted
- 19 May 2021
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data, analytic methods, and study materials will not be made available to other researchers for purposes of reproducing the results or replicating the procedure.
Publications
Choi KH, Lee SH, Kim SM, Hong D, Lee SY, Lee JM, Park TK, Yang JH, Ahn JH, Lim Y, Hyun DY, Cho KH, Kim MC, Lee JE, Kim YH, Hahn JY, Choi SH, Gwon HC, Ahn Y, Hong YJ, Song YB. SGLT2 Inhibitor on Infarct Size and LV Remodeling by CMR in Patients With AMI. JACC Cardiovasc Interv. 2026 Jul 27;19(14):1879-1891. doi: 10.1016/j.jcin.2026.04.017.
PubMed 42508844
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peri-tREatment of SGLT-2 Inhibitor on Myocardial Infarct Size and Remodeling Index Measured by Cardiac maGnetic rEsonance Imaging in Patients With Acute Myocardial Infarction and High Risk of Heart Failure Undergoing Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT04899479
- Acronym / sponsor ID
- PRESTIGE-AMI / PRESTIGE-AMI
- Conditions
- Acute Myocardial Infarction, Heart Failure
- Keywords
- Percutaneous Coronary Intervention, Infarct size, Cardiac Magnetic Resonance Imaging
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 5 Jul 2021 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 24 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We aimed to identify whether SGLT-2 inhibitor administration before and after coronary intervention is effective in reducing the size of infarction and myocardial remodeling in patients with acute myocardial infarction (AMI) and high risk of heart failure, and its mechanism. For this reason, we compared cardiac magnetic resonance imaging (CMR) parameters and clinical outcomes between the SGLT-2 inhibitor group and the control group to confirm the efficacy and safety of SGLT-2 inhibitors.
Detailed description
After the introduction of percutaneous coronary intervention (PCI) as a method to normalize blood flow in the treatment of coronary artery disease, not only the technical aspects of coronary intervention but also the devices and medications have been improved over the past 30 years. However, despite these advances, morbidity, and mortality of AMI are still high. In particular, in patients with ST-segment elevation MI (STEMI), the 1-year mortality rate and hospitalization rate due to heart failure are 10%, and 22%, respectively. Accordingly, various efforts are being made to improve the prognosis of AMI and to reduce the infarct size, which is a major prognostic factor. The most effective method for achieving this goal to early and successful revascularization by PCI. However, restoring blood flow, which is a prerequisite for relieving ischemia, can paradoxically cause damage to the myocardium and death of the myocardium by itself. This phenomenon is called myocardial reperfusion injury. Several pharmacological and mechanical treatments targeting this phenomenon have been studied, and the experimental and small-scale clinical trials have been shown to have the effect of reducing infarct size and relieving myocardium.4 However, to date, large-scale clinical trials have not demonstrated clinical benefits.
SGLT-2 inhibitors are developed to lower blood sugar and treat type 2 diabetes mellitus (DM) by inhibiting Sodium glucose co-transporter-2 in proximal renal tubule, releasing glucose into the urine and preventing reabsorption. However, SGLT-2 inhibitors are known to have an effect on lowering cardiovascular events in addition to lowering blood sugar. In three large-scale, multicenter, randomized trials to evaluate the effects of SGLT-2 in type 2 diabetic patients, the combined outcome consisting of cardiac death or readmission due to heart failure was significantly lowered compared to the placebo group. In particular, DECLARE-TIMI 58 trial confirmed that this effect was consistent regardless of the history of atherosclerotic cardiovascular disease or heart failure.8 In addition, DAPA-CKD trial showed that SGLT-2 inhibitor significantly reduced the composite outcome consisting of cardiovascular death or readmission due to heart failure as well as the kidney-related outcome compared to the placebo group in patients with chronic kidney disease regardless of type 2 DM. Similarly, EMPEROR-Reduced and DAPA-HF trials consistently demonstrated that SGLT-2 inhibitor was associated with significantly lower risk of a composite of cardiovascular death or worsening heart failure in patients with heart failure with reduced ejection fraction. Therefore, the current guideline recommended the use of SGLT-2 inhibitor in patients with heart failure with reduced ejection fraction, with a conjunction of goal-directed medical therapy. Nevertheless, the mechanism that can explain this has been extensively investigated, but it is not clear yet. Several potential hypotheses have been proposed as mechanisms such as increased natriuresis, decreased blood pressure, decreased inflammation, and decreased reactive oxidative stress. In this regard, it is anticipated that the use of SGLT-2 inhibitors will benefit even in patients with AMI and high risk of heart failure in both acute and chronic phases.
Therefore, we aimed to identify whether SGLT-2 inhibitor administration before and after coronary intervention is effective in reducing the size of infarction and myocardial remodeling in patients with AMI and high risk of heart failure, and its mechanism. For this reason, we compared CMR parameters and clinical outcomes between the SGLT-2 inhibitor group and the control group to confirm the efficacy and safety of SGLT-2 inhibitors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomization will be performed 1:1 between SGLT-2 inhibitor and control. Stratification will be done by DM and clinical presentation (STEMI vs. NSTEMI).
| Arm | Type | Receives |
|---|---|---|
| SGLT-2 inhibitor | Experimental | Drug: SGLT2 inhibitorThe SGLT-2 inhibitor group will receive SGLT-2 inhibitor once daily until the end of the study period. |
| Control | Placebo comparator | Other: ControlThe control group will not receive any additional drugs. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1) Subject must be at least 18 years of age 2) Subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of receiving SGLT-2 inhibitor and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure 3) Diagnosis of Type 1 myocardial infarction (MI) (ST-segment elevation MI [STEMI] or Non-ST-segment elevation MI [NSTEMI]) i) Detection of a rise and/or fall of cardiac troponin values with at least 1 value above the 99th percentile upper reference limit ii) Symptoms or electrocardiographic changes suggesting myocardial ischemia 4) High risk of heart failure (at least one of the two criteria below are met) i) Left ventricular ejection fraction < 50% ii) Symptoms or signs of pulmonary congestion requiring treatment
Key exclusion criteria (1 listed)
- 1) Target lesion is not suitable for PCI by operator's decision 2) Patients requiring cardiopulmonary resuscitation due to cardiac arrest before randomization 3) Rescue PCI after thrombolysis or facilitated PCI 4) Previous MI 5) Previous history of heart failure 6) Patients who have been taking SGLT-2 inhibitor 7) Patients with glomerular filtration rate < 30ml/min/1.73m2 or on dialysis 8) Type 1 diabetes mellitus (DM) 9) Known hypersensitivity or contraindications to study medications (SGLT-2 inhibitor) 10) Pregnant or lactating women 11) Non-cardiac co-morbid conditions are present with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment)
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 |
|---|---|---|
| SGLT2 inhibitorIn patients with AMI and high risk of heart failure, 1:1 randomization will be performed to either SGLT2 inhibitor or control group. | Drug | SGLT-2 inhibitor |
| ControlIn patients with AMI and high risk of heart failure, 1:1 randomization will be performed to either SGLT2 inhibitor or control group. | Other | Control |
Primary outcome
Myocardial infract size (IS)
Time frame: at 6-month follow-up
IS measured using CMR
∆Left ventricular end-systolic volume
Time frame: Between index hospitalization and 6-month follow-up
Difference of left ventricular end-systolic volume measured by CMR
20 secondary outcomes
Acute kidney injury
Time frame: Within 3 days after index PCI
Myocardial IS
Time frame: Within 3 days after index PCI
Microvascular obstruction (MVO)
Time frame: Within 3 days after index PCI
IS
Time frame: Within 3 days after index PCI
∆left ventricular end-diastolic volume
Time frame: Between index hospitalization and 6-month follow-up
∆left ventricular ejection fraction
Time frame: Between index hospitalization and 6-month follow-up
LV adverse remodeling
Time frame: Between index hospitalization and 6-month follow-up
LV reverse remodeling
Time frame: Between index hospitalization and 6-month follow-up
MVO
Time frame: at 6-month follow-up
Changes of NT-proBNP level
Time frame: Between index hospitalization and 6-month follow-up
Estimated glomerular filtration rate
Time frame: 6 months after index PCI
Cardiovascular death, myocardial infarction, cerebrovascular events, stent thrombosis, and re-hospitalization due to cardiac cause
Time frame: 12 months after index PCI
Cardiovascular death, or re-hospitalization due to cardiac cause
Time frame: 12 months after index PCI
All-cause death
Time frame: 12 months after index PCI
Cardiovascular death
Time frame: 12 months after index PCI
MI
Time frame: 12 months after index PCI
Repeat revascularization
Time frame: 12 months after index PCI
Re-hospitalization due to heart failure
Time frame: 12 months after index PCI
Re-hospitalization due to cardiac cause
Time frame: 12 months after index PCI
Cerebrovascular events
Time frame: 12 months after index PCI
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
- Derived from this study: PubMed 42508844Choi KH, Lee SH, Kim SM, Hong D, Lee SY, Lee JM, Park TK, Yang JH, Ahn JH, Lim Y, Hyun DY, Cho KH, Kim MC, Lee JE, Kim YH, Hahn JY, Choi SH, Gwon HC, Ahn Y, Hong YJ, Song YB. SGLT2 Inhibitor on Infarct Size and LV Remodeling by CMR in Patients With AMI. JACC Cardiovasc Interv. 2026 Jul 27;19(14):1879-1891. doi: 10.1016/j.jcin.2026.04.017.
- Individual participant dataSharing planned: No. The data, analytic methods, and study materials will not be made available to other researchers for purposes of reproducing the results or replicating the procedure.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing SGLT2 inhibitor in people with Acute Myocardial Infarction and Heart Failure, run by Samsung Medical Center at 1 site in South Korea.
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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 26 Jun 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 South Korea. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Young Bin Song, MD, PhD (82-2-3410-1246, youngbin.song@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myocardial infract size (IS) (time frame: at 6-month follow-up). The study lists 2 primary outcomes in all. 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 NCT04899479, which also lists 1 linked publication.
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 26 Jun 2025.