ST Elevation Myocardial InfarctionPhase 4NCT05709509
Effect of Colchicine on MMP-9, NOX2, and TGF-β1 in Myocardial Infarct
A Phase 4 study testing Colchicine, Percutaneous Coronary Intervention and Optimal medical treatment including statin, aspirin, P2Y12 inhibitor, and nitrate. in people with ST Elevation Myocardial Infarction and Colchicine, run by RSD dr. Soebandi at 1 site in Indonesia.
Trial summary
Reducing NOX-2, MMP-9, and TGF-β1 Expression in Preventing Ventricular Remodelling Post Acute ST-Segment Elevation Myocardial Infarction using Colchicine (Post Late Reperfusion Percutaneous Coronary Intervention and Non-Reperfusion and In Vitro Study on Ischemic Rat Cardiomyocyte Culture Model). Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- ST Elevation Myocardial Infarction, Colchicine, Cardiac Remodeling, Ventricular
- What is being tested?
- Colchicine, Percutaneous Coronary Intervention and Optimal medical treatment including statin, aspirin, P2Y12 inhibitor, and nitrate.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 148 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Jun 2022to 1 May 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who presenting with STEMI more than 12 hours from the onset of chest pain
- Aged 40-70 years
- Agreed with the informed consent
Who cannot join
- aged <40 or >70 years
- subjects that have unstable condition such as comorbid disease (infection, inflammation, malignancy, severe renal failure (EGFR <30), a history of hepatic cirrhosis, acute exacerbation of hepatitis, or severe liver disease, alcoholic patient, cardiac arrest, ventricular fibrillation or cardiogenic shock, unstable hemodynamic)
- subjects that have colchicine hypersensitivity
- pregnancy or breastfeed
Trial locations and contacts
1 site in 1 country.
Indonesia1 site, 1 recruiting
- Recruiting
RSD dr Soebandi
Jember, East Java, 68111
Suryono Suryono, MD (Cardiologist), +628123514186, suryonofiha@gmail.com
Suryono Suryono, MD (Cardiologist)
About this study
Official title: Effect of Colchicine in Regulating MMP-9, NOX-2, and TGF- β1 After Myocardial Infraction in Stable Patients
Reducing NOX-2, MMP-9, and TGF-β1 Expression in Preventing Ventricular Remodelling Post Acute ST-Segment Elevation Myocardial Infarction using Colchicine (Post Late Reperfusion Percutaneous Coronary Intervention and Non-Reperfusion and In Vitro Study on Ischemic Rat Cardiomyocyte Culture Model). Coronary heart disease (CHD) is the most common cause of mortality and disability worldwide. The handling of reperfusion in Indonesia is still far below the required standard. Most STEMI patients in Indonesia arrive late to a health facility with symptoms that have been present for more than 12 hours (late-onset). Heart failure following a myocardial infarction is one of the long-term complications of STEMI. Patients with STEMU who do not receive reperfusion were more likely to develop this consequence. According to several studies, microtubules in cardiomyocytes have been identified as an essential regulator of cardiomyocytes' ability to respond to shear stress, which offers compression resistance and facilitates mitochondrial energy production. Microtubule densification, which occurs due to remodelling in heart failure, disrupts the microtubule network. The role of reactive oxygen species (ROS) produced by ischemic myocardium in this remodelling is thus inextricably linked. NADPH oxidase is one of the enzymes involved (NOX). NOX-2 levels have been reported to be higher in myocardial infarction and cardiac remodelling, and it has a close interaction with microtubule network, with damage of microtubule tissue increasing NOX-2 generation of reactive oxygen species. By eroding the ECM and triggering cytokines and chemokines to recruit inflammatory cells to eliminate necrotic cardiomyocytes, matrix metalloproteinase 9 (MMP-9) aids tissue rebuilding. Induction and activation of endogenous TGF-signaling pathways after myocardial infarction have also been discovered to play a function. TGF-β may play a role in the resolution of the inflammatory response in the early stages of infarct repair by inactivating macrophages and decreasing endothelial cell chemokine and cytokine production. TGF-β stimulates the fibrogenic pathway by causing extracellular matrix deposition and fibrosis later. Colchicine is a commonly prescribed anti-inflammatory medication with a low cost. the mechanism of colchicine is tubulin binding, which prevents microtubule assembly and polymerization. Colchicine inhibits microtubule development at low concentrations and promotes microtubule depolymerization at higher concentrations. Several studies have demonstrated that low-dose colchicine can help reduce severe cardiac outcomes such as cardiovascular mortality, stroke, and cardiac arrest following myocardial infarction. Colchicine is known to cause partial restoration of microtubule tissue in the perinuclear region. Colchicine has also been shown in earlier research to reduce the expression of MMP-9, NOX2, and TGF-β This study aims to evaluate whether colchicine could prevent ventricular remodelling in STEMI patients with delayed reperfusion and non reperfusion. The minor hypothesis of this study was colchicine can lower NOX-2, MMP-9, and TGF-β expression in the clinical situation of patients with delayed and non-reperfusion STEMI following PCI. Randomization with 1:1 allocation were used to classify the patients, each group include 41 patients with one group receiving colchicine therapy and standard therapy and the other receiving standard therapy only. Colchicine administration was the independent variable. STEMI patients with delayed and non-reperfusion IKP who met the inclusion criteria are included in this randomized clinical trial. Left ventricular end-diastolic volume (LVEDV) was the dependent variable while serum MMP-9, NOX-2, and TGF-β were the intermediate variables. In the treatment group, colchicine 1 mg is administered before PCI or admission to the ICCU, and colchicine is continued at 0.5 mg/day for a month. Within 24 to 36 hours of treatment initiation, the patient had echocardiography, NOX-2, MMP-9, and TGF-β levels evaluated. On days 4-5, a second NOX-2, MMP-9, and TGF-β screening were performed. The follow up two months after treatment initiation includes an assessment of drug compliance, symptoms, and echocardiography. Depending on the normality of the data distribution, the difference between groups is performed using the unpaired T-test or the Mann-Whitney test. The significant difference between the treatment groups is indicated by a p-value of 0.05.
- Being tested
- Colchicine, Percutaneous Coronary Intervention, Optimal medical treatment including statin, aspirin, P2Y12 inhibitor, and nitrate.
- Keywords
- STEMI, Colchicine, MMP-9, NOX2, TGF-beta 1
- Medical subject headings
- ST Elevation Myocardial Infarction, Ventricular Remodeling, Camurati-Engelmann Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColchicineDrug
Colchicine: A major alkaloid from Colchicum autumnale L. and found also in other Colchicum species. commonly used as anti-inflammatory drugs.
Percutaneous Coronary InterventionProcedure or surgery
Percutaneous Coronary Intervention: a family of minimally invasive procedures used to open clogged coronary arteries (those that deliver blood to the heart)
Optimal medical treatment including statin, aspirin, P2Y12 inhibitor, and nitrate.Other
Also called No Intervention
The subjects just received optimal medical treatment including statin, aspirin, P2Y12 inhibitor, and nitrate.
| Study group | Role | What they receive |
|---|---|---|
| Late PCI + Colchicine | Experimental | Subjects that undergo late PCI (12-48 hours after STEMI), received optimal medical treatment (statin, aspirin, P2Y12 inhibitor, and nitrate), and colchicine Receives: Drug: Colchicine; Procedure: Percutaneous Coronary Intervention; Other: Optimal medical treatment including statin, aspirin, P2Y12 inhibitor, and nitrate. |
| Late PCI + Optimal Medical Treatment | Experimental | Subjects that undergo late PCI (12-48 hours after STEMI) and received optimal medical treatment (statin, aspirin, P2Y12 inhibitor, and nitrate) Receives: Procedure: Percutaneous Coronary Intervention; Other: Optimal medical treatment including statin, aspirin, P2Y12 inhibitor, and nitrate. |
| Optimal Medical Treatment + Colchicine | Experimental | Subjects that received optimal medical treatment (statin, aspirin, P2Y12 inhibitor, and nitrate) and colchicine Receives: Drug: Colchicine; Other: Optimal medical treatment including statin, aspirin, P2Y12 inhibitor, and nitrate. |
| Optimal Medical Treatment | Placebo comparator | Subjects that received optimal medical treatment (statin, aspirin, P2Y12 inhibitor, and nitrate) Receives: Other: Optimal medical treatment including statin, aspirin, P2Y12 inhibitor, and nitrate. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change between 24 hours MMP-9 to day 5
Matrix metallopeptidase 9 (MMP-9), also known as 92 kDa type IV collagenase, 92 kDa gelatinase or gelatinase B (GELB), is a matrixin, a class of enzymes that belong to the zinc-metalloproteinases family involved in the degradation of the extracellular matrix.
Measured: 24 Hours, Day 5
The change between 24 hours NOX2 to day 5
NADPH oxidase 2 (Nox2), also known as cytochrome b(558) subunit beta or Cytochrome b-245 heavy chain, is a protein that in humans is encoded by the NOX2 gene (also called CYBB gene). The protein is a superoxide generating enzyme which forms reactive oxygen species (ROS).
Measured: 24 Hours, Day 5
The change between 24 hours TGF-β1 to day 5
Transforming growth factor β1 (TGFB1) is a multifunctional secreted protein that generally regulates immune function,544 as well as cell survival and migration, through the Sma- and Mad-related proteins (SMAD) signaling pathway.
Measured: 24 Hours, Day 5
Left ventricular end-diastolic volume (LVEDV)
The volume of blood in the left ventricle at the end of ventricular filling is called the end-diastolic volume (EDV), which is about 120 mL in the adult human.
Measured: Month 1
Secondary outcomes (5)
Number of subjects with hypertension
Hypertension is defined as a systolic blood pressure (SBP) of 140 mm Hg or more, or a diastolic blood pressure (DBP) of 90 mm Hg or more
Measured: Baseline
Number of subjects with diabetes
History of diabetes is defined as having fasting blood glucose 126 mg/dL or HBA1c >6.5%
Measured: Baseline
Smoking status among the subjects
Smoking or Ex-smoking
Measured: Baseline
Number of subjects with dyslipidemia
Dyslipidemia is the imbalance of lipids such as cholesterol, low-density lipoprotein cholesterol, (LDL-C), triglycerides, and high-density lipoprotein (HDL)
Measured: Baseline
Type of infark among the subjects
Type of infark (large or small) that happen to the subjects
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2023
- Study start1 Jun 2022
- Primary completion1 May 2023 (estimated)
- Study completion1 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ST Elevation Myocardial InfarctionStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All subjects were allocated to 4 different groups: Late PCI + Colchicine, Late PCI + Optimal Medical Treatment, Optimal Medical Treatment + Colchicine, and Optimal Medical Treatment Only
- Masking
- None (open label)
- Enrolment
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RSD dr. Soebandi
- Sponsor type
- Other government
- Collaborators
- Universitas Jember, University of Brawijaya
- Responsible party
- Principal investigator, Suryono Suryono, RSD dr. Soebandi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05709509
- Sponsor's protocol ID
- colchicine and Cardiovascular
- Status last verified
- Apr 2023
- First submitted
- 12 Jan 2023
- Last updated
- 11 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Colchicine in Regulating MMP-9, NOX-2, and TGF- β1 After Myocardial Infraction in Stable Patients
- ClinicalTrials.gov ID
- NCT05709509
- Acronym / sponsor ID
- colchicine and Cardiovascular
- Keywords
- STEMI, Colchicine, MMP-9, NOX2, TGF-beta 1
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- RSD dr. SoebandiOther government
- Collaborators
- Universitas Jember, University of Brawijaya
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 May 2023 (estimated)
- Study completion
- 1 May 2023 (estimated)
- First posted
- 2 Feb 2023 (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.
Reducing NOX-2, MMP-9, and TGF-β1 Expression in Preventing Ventricular Remodelling Post Acute ST-Segment Elevation Myocardial Infarction using Colchicine (Post Late Reperfusion Percutaneous Coronary Intervention and Non-Reperfusion and In Vitro Study on Ischemic Rat Cardiomyocyte Culture Model). Coronary heart disease (CHD) is the most common cause of mortality and disability worldwide. The handling of reperfusion in Indonesia is still far below the required standard. Most STEMI patients in Indonesia arrive late to a health facility with symptoms that have been present for more than 12 hours (late-onset). Heart failure following a myocardial infarction is one of the long-term complications of STEMI. Patients with STEMU who do not receive reperfusion were more likely to develop this consequence. According to several studies, microtubules in cardiomyocytes have been identified as an essential regulator of cardiomyocytes' ability to respond to shear stress, which offers compression resistance and facilitates mitochondrial energy production. Microtubule densification, which occurs due to remodelling in heart failure, disrupts the microtubule network. The role of reactive oxygen species (ROS) produced by ischemic myocardium in this remodelling is thus inextricably linked. NADPH oxidase is one of the enzymes involved (NOX). NOX-2 levels have been reported to be higher in myocardial infarction and cardiac remodelling, and it has a close interaction with microtubule network, with damage of microtubule tissue increasing NOX-2 generation of reactive oxygen species. By eroding the ECM and triggering cytokines and chemokines to recruit inflammatory cells to eliminate necrotic cardiomyocytes, matrix metalloproteinase 9 (MMP-9) aids tissue rebuilding. Induction and activation of endogenous TGF-signaling pathways after myocardial infarction have also been discovered to play a function. TGF-β may play a role in the resolution of the inflammatory response in the early stages of infarct repair by inactivating macrophages and decreasing endothelial cell chemokine and cytokine production. TGF-β stimulates the fibrogenic pathway by causing extracellular matrix deposition and fibrosis later. Colchicine is a commonly prescribed anti-inflammatory medication with a low cost. the mechanism of colchicine is tubulin binding, which prevents microtubule assembly and polymerization. Colchicine inhibits microtubule development at low concentrations and promotes microtubule depolymerization at higher concentrations. Several studies have demonstrated that low-dose colchicine can help reduce severe cardiac outcomes such as cardiovascular mortality, stroke, and cardiac arrest following myocardial infarction. Colchicine is known to cause partial restoration of microtubule tissue in the perinuclear region. Colchicine has also been shown in earlier research to reduce the expression of MMP-9, NOX2, and TGF-β This study aims to evaluate whether colchicine could prevent ventricular remodelling in STEMI patients with delayed reperfusion and non reperfusion. The minor hypothesis of this study was colchicine can lower NOX-2, MMP-9, and TGF-β expression in the clinical situation of patients with delayed and non-reperfusion STEMI following PCI. Randomization with 1:1 allocation were used to classify the patients, each group include 41 patients with one group receiving colchicine therapy and standard therapy and the other receiving standard therapy only. Colchicine administration was the independent variable. STEMI patients with delayed and non-reperfusion IKP who met the inclusion criteria are included in this randomized clinical trial. Left ventricular end-diastolic volume (LVEDV) was the dependent variable while serum MMP-9, NOX-2, and TGF-β were the intermediate variables. In the treatment group, colchicine 1 mg is administered before PCI or admission to the ICCU, and colchicine is continued at 0.5 mg/day for a month. Within 24 to 36 hours of treatment initiation, the patient had echocardiography, NOX-2, MMP-9, and TGF-β levels evaluated. On days 4-5, a second NOX-2, MMP-9, and TGF-β screening were performed. The follow up two months after treatment initiation includes an assessment of drug compliance, symptoms, and echocardiography. Depending on the normality of the data distribution, the difference between groups is performed using the unpaired T-test or the Mann-Whitney test. The significant difference between the treatment groups is indicated by a p-value of 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- All subjects were allocated to 4 different groups: Late PCI + Colchicine, Late PCI + Optimal Medical Treatment, Optimal Medical Treatment + Colchicine, and Optimal Medical Treatment Only
| Arm | Type | Receives |
|---|---|---|
| Late PCI + Colchicine | Experimental | Drug: Colchicine, Procedure: Percutaneous Coronary Intervention, Other: Optimal medical treatment including statin, aspirin, P2Y12 inhibitor, and nitrate.Subjects that undergo late PCI (12-48 hours after STEMI), received optimal medical treatment (statin, aspirin, P2Y12 inhibitor, and nitrate), and colchicine |
| Late PCI + Optimal Medical Treatment | Experimental | Procedure: Percutaneous Coronary Intervention, Other: Optimal medical treatment including statin, aspirin, P2Y12 inhibitor, and nitrate.Subjects that undergo late PCI (12-48 hours after STEMI) and received optimal medical treatment (statin, aspirin, P2Y12 inhibitor, and nitrate) |
| Optimal Medical Treatment + Colchicine | Experimental | Drug: Colchicine, Other: Optimal medical treatment including statin, aspirin, P2Y12 inhibitor, and nitrate.Subjects that received optimal medical treatment (statin, aspirin, P2Y12 inhibitor, and nitrate) and colchicine |
| Optimal Medical Treatment | Placebo comparator | Other: Optimal medical treatment including statin, aspirin, P2Y12 inhibitor, and nitrate.Subjects that received optimal medical treatment (statin, aspirin, P2Y12 inhibitor, and nitrate) |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects who presenting with STEMI more than 12 hours from the onset of chest pain
- Aged 40-70 years
- Agreed with the informed consent
Key exclusion criteria (4 listed)
- aged <40 or >70 years
- subjects that have unstable condition such as comorbid disease (infection, inflammation, malignancy, severe renal failure (EGFR <30), a history of hepatic cirrhosis, acute exacerbation of hepatitis, or severe liver disease, alcoholic patient, cardiac arrest, ventricular fibrillation or cardiogenic shock, unstable hemodynamic)
- subjects that have colchicine hypersensitivity
- pregnancy or breastfeed
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 |
|---|---|---|
| ColchicineColchicine: A major alkaloid from Colchicum autumnale L. and found also in other Colchicum species. commonly used as anti-inflammatory drugs. | Drug | Late PCI + Colchicine, Optimal Medical Treatment + Colchicine |
| Percutaneous Coronary InterventionPercutaneous Coronary Intervention: a family of minimally invasive procedures used to open clogged coronary arteries (those that deliver blood to the heart) | Procedure or surgery | Late PCI + Colchicine, Late PCI + Optimal Medical Treatment |
| Optimal medical treatment including statin, aspirin, P2Y12 inhibitor, and nitrate.Also: No InterventionThe subjects just received optimal medical treatment including statin, aspirin, P2Y12 inhibitor, and nitrate. | Other | Late PCI + Colchicine, Late PCI + Optimal Medical Treatment, Optimal Medical Treatment, Optimal Medical Treatment + Colchicine |
Primary outcome
The change between 24 hours MMP-9 to day 5
Time frame: 24 Hours, Day 5
Matrix metallopeptidase 9 (MMP-9), also known as 92 kDa type IV collagenase, 92 kDa gelatinase or gelatinase B (GELB), is a matrixin, a class of enzymes that belong to the zinc-metalloproteinases family involved in the degradation of the extracellular matrix.
The change between 24 hours NOX2 to day 5
Time frame: 24 Hours, Day 5
NADPH oxidase 2 (Nox2), also known as cytochrome b(558) subunit beta or Cytochrome b-245 heavy chain, is a protein that in humans is encoded by the NOX2 gene (also called CYBB gene). The protein is a superoxide generating enzyme which forms reactive oxygen species (ROS).
The change between 24 hours TGF-β1 to day 5
Time frame: 24 Hours, Day 5
Transforming growth factor β1 (TGFB1) is a multifunctional secreted protein that generally regulates immune function,544 as well as cell survival and migration, through the Sma- and Mad-related proteins (SMAD) signaling pathway.
Left ventricular end-diastolic volume (LVEDV)
Time frame: Month 1
The volume of blood in the left ventricle at the end of ventricular filling is called the end-diastolic volume (EDV), which is about 120 mL in the adult human.
5 secondary outcomes
Number of subjects with hypertension
Time frame: Baseline
Number of subjects with diabetes
Time frame: Baseline
Smoking status among the subjects
Time frame: Baseline
Number of subjects with dyslipidemia
Time frame: Baseline
Type of infark among the subjects
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2023.
- Individual participant dataSharing planned: Undecided
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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.
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 Colchicine, Percutaneous Coronary Intervention and Optimal medical treatment including statin, aspirin, P2Y12 inhibitor, and nitrate. in people with ST Elevation Myocardial Infarction and Colchicine, run by RSD dr. Soebandi at 1 site in Indonesia.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 11 Apr 2023. 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 Indonesia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Suryono Suryono, MD (Cardiologist) (+628123514186, suryonofiha@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change between 24 hours MMP-9 to day 5 (time frame: 24 Hours, Day 5). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Apr 2023.