ST-Segment Elevated Myocardial InfarctionPhase 4NCT04157868
Early rhBNP on Myocardial Work in Patients With STEMI
A Phase 4 study testing rhBNP in people with ST-Segment Elevated Myocardial Infarction, run by RenJi Hospital.
Trial summary
The study intends to evaluate the efficacy of early rhBNP on myocardial work in patients with anterior ST-segment elevation myocardial infarction after percutaneous coronary intervention Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- ST-Segment Elevated Myocardial Infarction
- What is being tested?
- rhBNP
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 30 Nov 2019to 30 Nov 2022
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Anterior myocardial infarct (anterior myocardial infarct is defined as persistent chest pain for 30 mins at least, with ST-segment elevation of at least 0.2 mV in two or more contiguous precordial leads) within 12 hours after onsets of symptom;
- 2. No contraindication for rhBNP;
- 3. Left anterior descending (LAD) as culprit vessel, with TIMI 0-1 grade.
Who cannot join
- 1.Cardiogenic shock (systolic BP <90mmHg after fluid infusion or systolic BP<100mmHg after vasoactive drugs);
- 2. History of myocardial infarct;
- 3.Severe arrhythmia: with III degree A-V block ,atrial fibrillation,ventricular fibrillation,ventricular tachycardia;
- 4. Any history of severe renal or hepatic dysfunction (hepatic failure, cirrhosis, portal hypertension or active hepatitis); neutropenia or thrombocytopenia; known acute pancreatitis;
- 5. Pregnant or lactating;
- 6. life expectancy≤12 months;
- 7. Inability to follow the protocol and comply with follow-up requirements or any other reason the investigator feels would place the patient at increased risk;
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Impact of Early rhBNP on Myocardial Work in Patients With Anterior ST-segment Elevation Myocardial Infarction After Percutaneous Coronary Intervention
The study intends to evaluate the efficacy of early rhBNP on myocardial work in patients with anterior ST-segment elevation myocardial infarction after percutaneous coronary intervention
- Being tested
- rhBNP, Control
- Keywords
- ST-Segment Elevated Myocardial Infarction, rhBNP, non-invasive myocardial work
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rhBNPDrug
rhBNP intra-coronary injection 1.5 ug/kg loading dose, with intravenous injection 0.0075-0.01 ug/kg/min persistent for 72 hour.
ControlDrug
Saline intra-coronary injection 0.15ml/kg loading dose, with same intravenous injection speed for 72 hour.
| Study group | Role | What they receive |
|---|---|---|
| rhBNP | Experimental | rhBNP intra-coronary injection 1.5 ug/kg loading dose, with intravenous injection 0.0075-0.01 ug/kg/min persistent for 72 hour. Receives: Drug: rhBNP |
| Control | Placebo comparator | Saline intra-coronary injection 0.15ml/kg loading dose, with same intravenous injection speed for 72 hour after randomization. Receives: Drug: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global myocardial work efficiency by echocardiography
Echocardial myocardial work (MW) may identify early abnormalities in left ventricular(LV) function and may establish a more sensitive index for early stage LV dysfunction.Global MW was quantified by calculating the rate of regional shortening by differentiation of the strain tracing and multiplying by instantaneous LV pressure. This instantaneous measure of power was this integrated over time to measure MW as a function of time during systole (time interval from mitral valve closure through to mitral valve opening). During LV ejection, segments were analyzed for wasted work (WW) and/or constructive work (CW), with global values determined as the averages of all segmental values and displayed on the LV pressure-strain loop diagram.
Global myocardial work efficiency (GWE; %), constructive MW divided by the sum of CW and WW, expressed as a percentage.
Measured: 30 days after PCI
Secondary outcomes (4)
Global myocardial work index by echocardiography
Global myocardial work index (GWI): total work within the area of the LV PSL calculated frommitral valve closure to mitral valve opening.
Measured: Day 1, 7, 30 after PCI
Global myocardial constructive work by echocardiography
Global myocardial constructive work (mm Hg %), an estimate of the work performed by the LV segments consisting of shortening during systole plus lengthening in isovolumic relaxation.
Measured: Day 1, 7, 30 after PCI
Global myocardial waste work by echocardiography
Global myocardial waste work (mm Hg %), an estimate of negative work of the LV segments consisting of myocardial lengthening during systole plus any shortening during isovolumic relaxation.
Measured: Day 1, 7, 30 after PCI
Clinical Outcomes
Compound endpoints of all cause death, non-fatal reinfarction, heart failure, and stroke;
Measured: 30 days after PCI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2019
- Study start30 Nov 2019 (estimated)
- Primary completion30 Sep 2022 (estimated)
- Study completion30 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for ST-Segment Elevated Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Song Ding, MD,Ph.D., Principal investigator, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04157868
- Sponsor's protocol ID
- EARLY MYO-myocardial work
- Status last verified
- Nov 2019
- First submitted
- 5 Nov 2019
- Last updated
- 8 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Schwartz BG, Kloner RA. Coronary no reflow. J Mol Cell Cardiol. 2012 Apr;52(4):873-82. doi: 10.1016/j.yjmcc.2011.06.009. Epub 2011 Jun 21.
PubMed 21712046Niccoli G, Burzotta F, Galiuto L, Crea F. Myocardial no-reflow in humans. J Am Coll Cardiol. 2009 Jul 21;54(4):281-92. doi: 10.1016/j.jacc.2009.03.054.
PubMed 19608025Go AS, Mozaffarian D, Roger VL, Benjamin EJ, Berry JD, Blaha MJ, Dai S, Ford ES, Fox CS, Franco S, Fullerton HJ, Gillespie C, Hailpern SM, Heit JA, Howard VJ, Huffman MD, Judd SE, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Mackey RH, Magid DJ, Marcus GM, Marelli A, Matchar DB, McGuire DK, Mohler ER 3rd, Moy CS, Mussolino ME, Neumar RW, Nichol G, Pandey DK, Paynter NP, Reeves MJ, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Wong ND, Woo D, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2014 update: a report from the American Heart Association. Circulation. 2014 Jan 21;129(3):e28-e292. doi: 10.1161/01.cir.0000441139.02102.80. Epub 2013 Dec 18. No abstract available.
PubMed 24352519Kehat I, Molkentin JD. Molecular pathways underlying cardiac remodeling during pathophysiological stimulation. Circulation. 2010 Dec 21;122(25):2727-35. doi: 10.1161/CIRCULATIONAHA.110.942268. No abstract available.
PubMed 21173361Postma S, Dambrink JH, Gosselink AT, Ottervanger JP, Kolkman E, Ten Berg JM, Suryapranata H, van 't Hof AW. The influence of system delay on 30-day and on long-term mortality in patients with anterior versus non-anterior ST-segment elevation myocardial infarction: a cohort study. Open Heart. 2015 Apr 10;2(1):e000201. doi: 10.1136/openhrt-2014-000201. eCollection 2015.
PubMed 25893101Wu GF, Wykrzykowska JJ, Rana JS, Pinto DS, Gibson CM, Li J, Sellke FW, Laham RJ. Effects of B-type natriuretic peptide (nesiritide) on coronary epicardial arteries, systemic vasculature and microvessels. J Invasive Cardiol. 2008 Feb;20(2):76-80.
PubMed 18252972Sjoli B, Orn S, Grenne B, Ihlen H, Edvardsen T, Brunvand H. Diagnostic capability and reproducibility of strain by Doppler and by speckle tracking in patients with acute myocardial infarction. JACC Cardiovasc Imaging. 2009 Jan;2(1):24-33. doi: 10.1016/j.jcmg.2008.10.007.
PubMed 19356529Shimoni S, Gendelman G, Ayzenberg O, Smirin N, Lysyansky P, Edri O, Deutsch L, Caspi A, Friedman Z. Differential effects of coronary artery stenosis on myocardial function: the value of myocardial strain analysis for the detection of coronary artery disease. J Am Soc Echocardiogr. 2011 Jul;24(7):748-57. doi: 10.1016/j.echo.2011.03.007. Epub 2011 Apr 20.
PubMed 21511433Hubert A, Le Rolle V, Leclercq C, Galli E, Samset E, Casset C, Mabo P, Hernandez A, Donal E. Estimation of myocardial work from pressure-strain loops analysis: an experimental evaluation. Eur Heart J Cardiovasc Imaging. 2018 Dec 1;19(12):1372-1379. doi: 10.1093/ehjci/jey024.
PubMed 29529181Donal E, Bergerot C, Thibault H, Ernande L, Loufoua J, Augeul L, Ovize M, Derumeaux G. Influence of afterload on left ventricular radial and longitudinal systolic functions: a two-dimensional strain imaging study. Eur J Echocardiogr. 2009 Dec;10(8):914-21. doi: 10.1093/ejechocard/jep095. Epub 2009 Aug 7.
PubMed 19666722Edwards NFA, Scalia GM, Shiino K, Sabapathy S, Anderson B, Chamberlain R, Khandheria BK, Chan J. Global Myocardial Work Is Superior to Global Longitudinal Strain to Predict Significant Coronary Artery Disease in Patients With Normal Left Ventricular Function and Wall Motion. J Am Soc Echocardiogr. 2019 Aug;32(8):947-957. doi: 10.1016/j.echo.2019.02.014. Epub 2019 Apr 28.
PubMed 31043359Masci PG, Marinelli M, Piacenti M, Lorenzoni V, Positano V, Lombardi M, L'Abbate A, Neglia D. Myocardial structural, perfusion, and metabolic correlates of left bundle branch block mechanical derangement in patients with dilated cardiomyopathy: a tagged cardiac magnetic resonance and positron emission tomography study. Circ Cardiovasc Imaging. 2010 Jul;3(4):482-90. doi: 10.1161/CIRCIMAGING.109.934638. Epub 2010 May 12.
PubMed 20463209Duchenne J, Turco A, Unlu S, Pagourelias ED, Vunckx K, Degtiarova G, Bezy S, Cvijic M, Nuyts J, Claus P, Rega F, Gheysens O, Voigt JU. Left Ventricular Remodeling Results in Homogenization of Myocardial Work Distribution. Circ Arrhythm Electrophysiol. 2019 May;12(5):e007224. doi: 10.1161/CIRCEP.118.007224.
PubMed 31023060Boe E, Russell K, Eek C, Eriksen M, Remme EW, Smiseth OA, Skulstad H. Non-invasive myocardial work index identifies acute coronary occlusion in patients with non-ST-segment elevation-acute coronary syndrome. Eur Heart J Cardiovasc Imaging. 2015 Nov;16(11):1247-55. doi: 10.1093/ehjci/jev078. Epub 2015 Apr 6.
PubMed 25851329
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Early rhBNP on Myocardial Work in Patients With Anterior ST-segment Elevation Myocardial Infarction After Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT04157868
- Acronym / sponsor ID
- EARLY MYO-myocardial work
- Keywords
- ST-Segment Elevated Myocardial Infarction, rhBNP, non-invasive myocardial work
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 30 Nov 2019 (estimated)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 30 Nov 2022 (estimated)
- First posted
- 8 Nov 2019 (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.
The study intends to evaluate the efficacy of early rhBNP on myocardial work in patients with anterior ST-segment elevation myocardial infarction after percutaneous coronary intervention
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rhBNP | Experimental | Drug: rhBNPrhBNP intra-coronary injection 1.5 ug/kg loading dose, with intravenous injection 0.0075-0.01 ug/kg/min persistent for 72 hour. |
| Control | Placebo comparator | Drug: ControlSaline intra-coronary injection 0.15ml/kg loading dose, with same intravenous injection speed for 72 hour after randomization. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 1. Anterior myocardial infarct (anterior myocardial infarct is defined as persistent chest pain for 30 mins at least, with ST-segment elevation of at least 0.2 mV in two or more contiguous precordial leads) within 12 hours after onsets of symptom;
- 2. No contraindication for rhBNP;
- 3. Left anterior descending (LAD) as culprit vessel, with TIMI 0-1 grade.
Key exclusion criteria (7 listed)
- 1.Cardiogenic shock (systolic BP <90mmHg after fluid infusion or systolic BP<100mmHg after vasoactive drugs);
- 2. History of myocardial infarct;
- 3.Severe arrhythmia: with III degree A-V block ,atrial fibrillation,ventricular fibrillation,ventricular tachycardia;
- 4. Any history of severe renal or hepatic dysfunction (hepatic failure, cirrhosis, portal hypertension or active hepatitis); neutropenia or thrombocytopenia; known acute pancreatitis;
- 5. Pregnant or lactating;
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 |
|---|---|---|
| rhBNPrhBNP intra-coronary injection 1.5 ug/kg loading dose, with intravenous injection 0.0075-0.01 ug/kg/min persistent for 72 hour. | Drug | rhBNP |
| ControlSaline intra-coronary injection 0.15ml/kg loading dose, with same intravenous injection speed for 72 hour. | Drug | Control |
Primary outcome
Global myocardial work efficiency by echocardiography
Time frame: 30 days after PCI
Echocardial myocardial work (MW) may identify early abnormalities in left ventricular(LV) function and may establish a more sensitive index for early stage LV dysfunction.Global MW was quantified by calculating the rate of regional shortening by differentiation of the strain tracing and multiplying by instantaneous LV pressure. This instantaneous measure of power was this integrated over time to measure MW as a function of time during systole (time interval from mitral valve closure through to mitral valve opening). During LV ejection, segments were analyzed for wasted work (WW) and/or constructive work (CW), with global values determined as the averages of all segmental values and displayed on the LV pressure-strain loop diagram. Global myocardial work efficiency (GWE; %), constructive MW divided by the sum of CW and WW, expressed as a percentage.
4 secondary outcomes
Global myocardial work index by echocardiography
Time frame: Day 1, 7, 30 after PCI
Global myocardial constructive work by echocardiography
Time frame: Day 1, 7, 30 after PCI
Global myocardial waste work by echocardiography
Time frame: Day 1, 7, 30 after PCI
Clinical Outcomes
Time frame: 30 days after PCI
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2019.
- Background: PubMed 21712046Schwartz BG, Kloner RA. Coronary no reflow. J Mol Cell Cardiol. 2012 Apr;52(4):873-82. doi: 10.1016/j.yjmcc.2011.06.009. Epub 2011 Jun 21.
- Background: PubMed 19608025Niccoli G, Burzotta F, Galiuto L, Crea F. Myocardial no-reflow in humans. J Am Coll Cardiol. 2009 Jul 21;54(4):281-92. doi: 10.1016/j.jacc.2009.03.054.
- Background: PubMed 24352519Go AS, Mozaffarian D, Roger VL, Benjamin EJ, Berry JD, Blaha MJ, Dai S, Ford ES, Fox CS, Franco S, Fullerton HJ, Gillespie C, Hailpern SM, Heit JA, Howard VJ, Huffman MD, Judd SE, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Mackey RH, Magid DJ, Marcus GM, Marelli A, Matchar DB, McGuire DK, Mohler ER 3rd, Moy CS, Mussolino ME, Neumar RW, Nichol G, Pandey DK, Paynter NP, Reeves MJ, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Wong ND, Woo D, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2014 update: a report from the American Heart Association. Circulation. 2014 Jan 21;129(3):e28-e292. doi: 10.1161/01.cir.0000441139.02102.80. Epub 2013 Dec 18. No abstract available.
- Background: PubMed 21173361Kehat I, Molkentin JD. Molecular pathways underlying cardiac remodeling during pathophysiological stimulation. Circulation. 2010 Dec 21;122(25):2727-35. doi: 10.1161/CIRCULATIONAHA.110.942268. No abstract available.
- Background: PubMed 25893101Postma S, Dambrink JH, Gosselink AT, Ottervanger JP, Kolkman E, Ten Berg JM, Suryapranata H, van 't Hof AW. The influence of system delay on 30-day and on long-term mortality in patients with anterior versus non-anterior ST-segment elevation myocardial infarction: a cohort study. Open Heart. 2015 Apr 10;2(1):e000201. doi: 10.1136/openhrt-2014-000201. eCollection 2015.
- Background: PubMed 18252972Wu GF, Wykrzykowska JJ, Rana JS, Pinto DS, Gibson CM, Li J, Sellke FW, Laham RJ. Effects of B-type natriuretic peptide (nesiritide) on coronary epicardial arteries, systemic vasculature and microvessels. J Invasive Cardiol. 2008 Feb;20(2):76-80.
- Background: PubMed 19356529Sjoli B, Orn S, Grenne B, Ihlen H, Edvardsen T, Brunvand H. Diagnostic capability and reproducibility of strain by Doppler and by speckle tracking in patients with acute myocardial infarction. JACC Cardiovasc Imaging. 2009 Jan;2(1):24-33. doi: 10.1016/j.jcmg.2008.10.007.
- Background: PubMed 21511433Shimoni S, Gendelman G, Ayzenberg O, Smirin N, Lysyansky P, Edri O, Deutsch L, Caspi A, Friedman Z. Differential effects of coronary artery stenosis on myocardial function: the value of myocardial strain analysis for the detection of coronary artery disease. J Am Soc Echocardiogr. 2011 Jul;24(7):748-57. doi: 10.1016/j.echo.2011.03.007. Epub 2011 Apr 20.
- Background: PubMed 29529181Hubert A, Le Rolle V, Leclercq C, Galli E, Samset E, Casset C, Mabo P, Hernandez A, Donal E. Estimation of myocardial work from pressure-strain loops analysis: an experimental evaluation. Eur Heart J Cardiovasc Imaging. 2018 Dec 1;19(12):1372-1379. doi: 10.1093/ehjci/jey024.
- Background: PubMed 19666722Donal E, Bergerot C, Thibault H, Ernande L, Loufoua J, Augeul L, Ovize M, Derumeaux G. Influence of afterload on left ventricular radial and longitudinal systolic functions: a two-dimensional strain imaging study. Eur J Echocardiogr. 2009 Dec;10(8):914-21. doi: 10.1093/ejechocard/jep095. Epub 2009 Aug 7.
- Background: PubMed 31043359Edwards NFA, Scalia GM, Shiino K, Sabapathy S, Anderson B, Chamberlain R, Khandheria BK, Chan J. Global Myocardial Work Is Superior to Global Longitudinal Strain to Predict Significant Coronary Artery Disease in Patients With Normal Left Ventricular Function and Wall Motion. J Am Soc Echocardiogr. 2019 Aug;32(8):947-957. doi: 10.1016/j.echo.2019.02.014. Epub 2019 Apr 28.
- Background: PubMed 20463209Masci PG, Marinelli M, Piacenti M, Lorenzoni V, Positano V, Lombardi M, L'Abbate A, Neglia D. Myocardial structural, perfusion, and metabolic correlates of left bundle branch block mechanical derangement in patients with dilated cardiomyopathy: a tagged cardiac magnetic resonance and positron emission tomography study. Circ Cardiovasc Imaging. 2010 Jul;3(4):482-90. doi: 10.1161/CIRCIMAGING.109.934638. Epub 2010 May 12.
- 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.
Song Ding, MD,Ph.D. principal investigator
Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing rhBNP in people with ST-Segment Elevated Myocardial Infarction, run by RenJi Hospital.
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 7 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 8 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
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 Song Ding, MD,Ph.D. (86-21-68383477, dingsong1105@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global myocardial work efficiency by echocardiography (time frame: 30 days after PCI). 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 NCT04157868, which also lists 14 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 8 Nov 2019.