Cardiac ArrestHYPERIONNCT01994772
Therapeutic Hypothermia After Cardiac Arrest in Non Shockable Rhythm
A study of Cardiac Arrest, run by Centre Hospitalier Departemental Vendee at 26 sites in 2 countries.
Trial summary
Cardiac arrest is at present a major cause of mortality as well as a cause of disability for the surviving victims.In Europe, every year counts as 300,000 cardiac arrests responsible for 250,000 deaths. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 584 participants
- Where
- 26 sitesin 2 countries
- Study dates
- 26 Jan 2014to 9 Apr 2018
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cardiac arrest in non shockable rhythm
- Glasgow score ≤ 8
Who cannot join
- No flow > 10 min
- Low flow > 60 min
- Major hemodynamic instability
- Delay between cardiac arrest and inclusion > 300 min
- Cirrhosis Child C
- Age < 18 years
Show all 10Show fewer
- Pregnant women
- Patient with no liberty
- Lack of informed consent
- Prior inclusion in a research protocol involving cardiac arrest with draw, and whose primary endpoint focuses on the evaluation of a neurological score Day 90
Trial locations and contacts
26 sites in 2 countries.
26 sites in 2 countries
France25 sites
Medical Intensive Care Unit
Angers
Medical Surgical Intensive Care Unit
Angoulême
Medical Intensive Care Unit
Annecy, 74374
Medical Surgical Intensive Care Unit
Argenteuil
Medical Intensive Care Unit
Clermont-Ferrand, 63003
Medical Intensive Care Unit
Dijon
Medical Surgical Intensive Care Unit
La Roche-sur-Yon
Medical Surgical Intensive Care Unit
Le Mans
Medical Surgical Intensive Care Unit
Lens
Medical Intensive Care Unit
Lille, 59037
Medical Surgical Intensive Care Unit
Limoges
Medical Surgical Intensive Care Unit
Lorient, 56322
Medical Surgical Intensive Care Unit
Montauban
Medical Intensive Care Unit
Nantes
Medical Intensive Care Unit
Orléans
Cochin University Hospital Center
Paris
Medical Intensive Care Unit
Poitiers
Medical Surgical Intensive Care Unit
Roanne, 42300
Medical Surgical Intensive Care Unit
Rodez, 12000
Medical Surgical Intensive Care Unit
Saint-Brieuc
Medical Surgical Intensive Care Unit
Saint-Nazaire
Medical Surgical Intensive Care Unit
St-Malo, 35400
Medical Intensive Care Unit
Strasbourg
Medical Intensive Care Unit
Tours
Medical Surgical Intensive Care Unit
Versailles
About this study
Official title: Therapeutic Hypothermia After Cardiac Arrest in Non Shockable Rhythm at Rescue Arrival: The HYPERION Study
Cardiac arrest is at present a major cause of mortality as well as a cause of disability for the surviving victims.In Europe, every year counts as 300,000 cardiac arrests responsible for 250,000 deaths. Thus, less than 20 % of patients discharged home with impaired quality of life associated with symptoms of tiredness, stress, anxiety. The prognosis is related to the initial cardiac rhythm present during the initiation of resuscitation. Recent progress in the improvement of mortality and neurological outcome has been achieved over the last decade thanks to the systematic implementation of a period of targeted temperature control between 32 and 34 ° C in patients who benefited from the realization of at least one electrical external shock.
There are theoretical and clinical arguments to think that achieving the same way a period of targeted temperature control between 32 and 34 ° C in patients treated for cardiac arrest with a non- shockable rhythm on arrival can also benefit from this procedure. However other arguments are against this hypothesis including an increase in the risk of infection , worsening of the patient's hemodynamic status with no benefit to him. To answer this question, we conduce a randomized multicenter study testing the potential improvement of neurological outcome through this procedure targeted temperature control between 32.5 and 33.5 ° C in these patients.
- Conditions
- Cardiac Arrest
- Being tested
- Targeted controlled temperature between 32.5 and 33.5°C, Targeted controlled temperature between 36.5 and 37.5°C
- Keywords
- Therapeutic hypothermia, Targeted controlled temperature, Cardiac arrest, Non shockable rhythm, successful resuscitation
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Targeted controlled temperature between 32.5 and 33.5°CProcedure or surgery
Also called Therapeutic hypothermia, Induce hypothermia
Therapeutic hypothermia ie targeted controlled temperature between 32.5° and 33.5°C will be induced in the active group. Usual method of controlled temperature will be use in ICU: internal active method or external active method.
Targeted controlled temperature between 36.5 and 37.5°CProcedure or surgery
Also called Normothermia
Temperature was maintain between 36.5° and 37.5°C in the control group. In case of temperature superior to 37.5°C or inferior to 36.5°C, a pharmaceutical treatment and/or active cooling or warming was introduce to maintain temperature between the range of 36.5 - 37.5°C.
| Study group | Role | What they receive |
|---|---|---|
| Targeted controlled temperature between 32.5 and 33.5°C | Active comparator | Patients will be placed in targeted temperature control between 32.5 and 33.5 ° C for 24 hours and then slowly rewarmed for targeted temperature control between 36.5 and 37.5 ° C for 24 hours. Receives: Procedure: Targeted controlled temperature between 32.5 and 33.5°C; Procedure: Targeted controlled temperature between 36.5 and 37.5°C |
| Targeted controlled temperature between 36.5 and 37.5°C | Placebo comparator | Patients will be placed in targeted temperature control between 36.5 and 37.5 ° C for 48 hours. Receives: Procedure: Targeted controlled temperature between 36.5 and 37.5°C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurological outcome assessed with Cerebral Performance Category scale
Measured: Day 90
Secondary outcomes (20)
Intensive Care Unit Mortality
Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 7 days.
Measured: Discharge from Intensive Care Unit, an expected average of 7 days
Hospital Mortality
Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Measured: Discharge from hospital, an expected average of 2 weeks
Mortality at day 90
Measured: Day 90
Quality of life Score
Quality of life at day 90 will be assessed by 36-Items Short Form for Health Survey telephonic interview
Measured: Day 90
Life autonomy
Life autonomy will be assessed by Index Activity of Daily Living, modified Barthel index, and by two normative question about life autonomy
Measured: Day 90
Neurocognitive evaluation
Neurocognitive status will be assessed by telephonic validated version of Mini Mental State Examination
Measured: Day 90
Post traumatic stress disorders symptoms
Post traumatic stress disorders symptoms will be assessed by Impact Event Scale Revised
Measured: Day 90
Intensive Care Unit length of stay
Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 7 days
Measured: Discharge from Intensive Care Unit, an expected average of 7 days
Hospital length of stay
Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
Measured: Discharge from hospital, an expected average of 2 weeks
Mechanical ventilation duration
Participants will be followed for the duration of mechanical ventilation, an expected average of 4 days
Measured: Time from extubation, an expected average of 4 days
Severe hemorrhage
Severe hemorrhage is define by transfusion of 1 or more blood product requirement and/or intracranial hemorrhage. Participants will be followed for the duration of Intensive care unit stay, an expected average of 7 days.
Measured: Intensive care unit length of stay, an expected average of 7 days
Nosocomial Bloodstream infection
Participants will be followed for the duration of Intensive care unit stay, an expected average of 7 days.
Measured: Intensive care unit length of stay, an expected average of 7 days
Early onset pneumonia
Measured: 2 days
Ventilated Associated Pneumonia
Participants will be followed for the duration of mechanical ventilation, an expected average of 4 days
Measured: Duration of mechanical ventilation, an expected average of 4 days
Central Veinous Catheter infection
Participants will be followed for the duration of Intensive care unit stay, an expected average of 7 days.
Measured: Intensive care unit length of stay, an expected average of 7 days
Total dose of inotropic drugs
Total dose of different inotropic drugs (Epinephrine, Norepinephrine, Dobutamine) will be compare between 2 groups during targetted controlled temperature management period.
Measured: 48 hours
Extra renal support requirement
Participants will be followed for the duration of Intensive care unit stay, an expected average of 7 days
Measured: Intensive care unit length of stay, an expected 7 days
Acute pulmonary oedema by left ventricular failure
Participants will be followed for the duration of Intensive care unit stay, an expected average of 7 days.
Measured: Intensive care length of stay, an expected 7 days
Seizure
Participants will be followed for the duration of Intensive care unit stay, an expected average of 7 days
Measured: Intensive care length of stay, an expected 7 days
Severe arrythmia
Severe arrythmia will be define by salvo of ventricular extrasystole, ventricular fibrillation, ventricular tachycardia, need an external shock, need anti-arrhythmic treatment. Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 7 days.
Measured: Intensive care unit length of stay, an expected 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2013 (estimated)
- Study start26 Jan 2014
- Primary completion9 Apr 2018
- Study completion9 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cardiac ArrestStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 584 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Departemental Vendee
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Tours
- Responsible party
- Sponsor
- Investigators
- Jean Baptiste Lascarrou, MD, Study chair, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01994772
- Sponsor's protocol ID
- RCB 2012-A00405-38
- Acronym
- HYPERION
- Status last verified
- Jan 2019
- First submitted
- 7 Nov 2013
- Last updated
- 16 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lascarrou JB, Ermel C, Cariou A, Laitio T, Kirkegaard H, Soreide E, Grejs AM, Reinikainen M, Colin G, Taccone FS, Le Gouge A, Skrifvars MB. Dysnatremia at ICU admission and functional outcome of cardiac arrest: insights from four randomised controlled trials. Crit Care. 2023 Dec 1;27(1):472. doi: 10.1186/s13054-023-04715-z.
PubMed 38041177Ziriat I, Le Thuaut A, Colin G, Merdji H, Grillet G, Girardie P, Souweine B, Dequin PF, Boulain T, Frat JP, Asfar P, Francois B, Landais M, Plantefeve G, Quenot JP, Chakarian JC, Sirodot M, Legriel S, Massart N, Thevenin D, Desachy A, Delahaye A, Botoc V, Vimeux S, Martino F, Reignier J, Cariou A, Lascarrou JB. Outcomes of mild-to-moderate postresuscitation shock after non-shockable cardiac arrest and association with temperature management: a post hoc analysis of HYPERION trial data. Ann Intensive Care. 2022 Oct 17;12(1):96. doi: 10.1186/s13613-022-01071-z.
PubMed 36251223Lascarrou JB, Merdji H, Le Gouge A, Colin G, Grillet G, Girardie P, Coupez E, Dequin PF, Cariou A, Boulain T, Brule N, Frat JP, Asfar P, Pichon N, Landais M, Plantefeve G, Quenot JP, Chakarian JC, Sirodot M, Legriel S, Letheulle J, Thevenin D, Desachy A, Delahaye A, Botoc V, Vimeux S, Martino F, Giraudeau B, Reignier J; CRICS-TRIGGERSEP Group. Targeted Temperature Management for Cardiac Arrest with Nonshockable Rhythm. N Engl J Med. 2019 Dec 12;381(24):2327-2337. doi: 10.1056/NEJMoa1906661. Epub 2019 Oct 2.
PubMed 31577396Lascarrou JB, Meziani F, Le Gouge A, Boulain T, Bousser J, Belliard G, Asfar P, Frat JP, Dequin PF, Gouello JP, Delahaye A, Hssain AA, Chakarian JC, Pichon N, Desachy A, Bellec F, Thevenin D, Quenot JP, Sirodot M, Labadie F, Plantefeve G, Vivier D, Girardie P, Giraudeau B, Reignier J; Clinical Research in Intensive Care and Sepsis (CRICS) Group and HYPERION Study Group. Therapeutic hypothermia after nonshockable cardiac arrest: the HYPERION multicenter, randomized, controlled, assessor-blinded, superiority trial. Scand J Trauma Resusc Emerg Med. 2015 Mar 7;23:26. doi: 10.1186/s13049-015-0103-5.
PubMed 25882712
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Hypothermia After Cardiac Arrest in Non Shockable Rhythm at Rescue Arrival: The HYPERION Study
- ClinicalTrials.gov ID
- NCT01994772
- Acronym / sponsor ID
- HYPERION / RCB 2012-A00405-38
- Conditions
- Cardiac Arrest
- Keywords
- Therapeutic hypothermia, Targeted controlled temperature, Cardiac arrest, Non shockable rhythm, successful resuscitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 584 participants (actual)
- Lead sponsor
- Centre Hospitalier Departemental VendeeUniversity, hospital or other
- Collaborators
- University Hospital, Tours
- Study start
- 26 Jan 2014 (actual)
- Primary completion
- 9 Apr 2018 (actual)
- Study completion
- 9 Apr 2018 (actual)
- First posted
- 26 Nov 2013 (estimated)
- 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.
Cardiac arrest is at present a major cause of mortality as well as a cause of disability for the surviving victims.In Europe, every year counts as 300,000 cardiac arrests responsible for 250,000 deaths. Thus, less than 20 % of patients discharged home with impaired quality of life associated with symptoms of tiredness, stress, anxiety. The prognosis is related to the initial cardiac rhythm present during the initiation of resuscitation. Recent progress in the improvement of mortality and neurological outcome has been achieved over the last decade thanks to the systematic implementation of a period of targeted temperature control between 32 and 34 ° C in patients who benefited from the realization of at least one electrical external shock.
There are theoretical and clinical arguments to think that achieving the same way a period of targeted temperature control between 32 and 34 ° C in patients treated for cardiac arrest with a non- shockable rhythm on arrival can also benefit from this procedure. However other arguments are against this hypothesis including an increase in the risk of infection , worsening of the patient's hemodynamic status with no benefit to him. To answer this question, we conduce a randomized multicenter study testing the potential improvement of neurological outcome through this procedure targeted temperature control between 32.5 and 33.5 ° C in these patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Targeted controlled temperature between 32.5 and 33.5°C | Active comparator | Procedure: Targeted controlled temperature between 32.5 and 33.5°C, Procedure: Targeted controlled temperature between 36.5 and 37.5°CPatients will be placed in targeted temperature control between 32.5 and 33.5 ° C for 24 hours and then slowly rewarmed for targeted temperature control between 36.5 and 37.5 ° C for 24 hours. |
| Targeted controlled temperature between 36.5 and 37.5°C | Placebo comparator | Procedure: Targeted controlled temperature between 36.5 and 37.5°CPatients will be placed in targeted temperature control between 36.5 and 37.5 ° C for 48 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Cardiac arrest in non shockable rhythm
- Glasgow score ≤ 8
Key exclusion criteria (10 listed)
- No flow > 10 min
- Low flow > 60 min
- Major hemodynamic instability
- Delay between cardiac arrest and inclusion > 300 min
- Cirrhosis Child C
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 |
|---|---|---|
| Targeted controlled temperature between 32.5 and 33.5°CAlso: Therapeutic hypothermia, Induce hypothermiaTherapeutic hypothermia ie targeted controlled temperature between 32.5° and 33.5°C will be induced in the active group. Usual method of controlled temperature will be use in ICU: internal active method or external active method. | Procedure or surgery | Targeted controlled temperature between 32.5 and 33.5°C |
| Targeted controlled temperature between 36.5 and 37.5°CAlso: NormothermiaTemperature was maintain between 36.5° and 37.5°C in the control group. In case of temperature superior to 37.5°C or inferior to 36.5°C, a pharmaceutical treatment and/or active cooling or warming was introduce to maintain temperature between the range of 36.5 - 37.5°C. | Procedure or surgery | Targeted controlled temperature between 32.5 and 33.5°C, Targeted controlled temperature between 36.5 and 37.5°C |
Primary outcome
Neurological outcome assessed with Cerebral Performance Category scale
Time frame: Day 90
20 secondary outcomes
Intensive Care Unit Mortality
Time frame: Discharge from Intensive Care Unit, an expected average of 7 days
Hospital Mortality
Time frame: Discharge from hospital, an expected average of 2 weeks
Mortality at day 90
Time frame: Day 90
Quality of life Score
Time frame: Day 90
Life autonomy
Time frame: Day 90
Neurocognitive evaluation
Time frame: Day 90
Post traumatic stress disorders symptoms
Time frame: Day 90
Intensive Care Unit length of stay
Time frame: Discharge from Intensive Care Unit, an expected average of 7 days
Hospital length of stay
Time frame: Discharge from hospital, an expected average of 2 weeks
Mechanical ventilation duration
Time frame: Time from extubation, an expected average of 4 days
Severe hemorrhage
Time frame: Intensive care unit length of stay, an expected average of 7 days
Nosocomial Bloodstream infection
Time frame: Intensive care unit length of stay, an expected average of 7 days
Early onset pneumonia
Time frame: 2 days
Ventilated Associated Pneumonia
Time frame: Duration of mechanical ventilation, an expected average of 4 days
Central Veinous Catheter infection
Time frame: Intensive care unit length of stay, an expected average of 7 days
Total dose of inotropic drugs
Time frame: 48 hours
Extra renal support requirement
Time frame: Intensive care unit length of stay, an expected 7 days
Acute pulmonary oedema by left ventricular failure
Time frame: Intensive care length of stay, an expected 7 days
Seizure
Time frame: Intensive care length of stay, an expected 7 days
Severe arrythmia
Time frame: Intensive care unit length of stay, an expected 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2019.
- Derived from this study: PubMed 38041177Lascarrou JB, Ermel C, Cariou A, Laitio T, Kirkegaard H, Soreide E, Grejs AM, Reinikainen M, Colin G, Taccone FS, Le Gouge A, Skrifvars MB. Dysnatremia at ICU admission and functional outcome of cardiac arrest: insights from four randomised controlled trials. Crit Care. 2023 Dec 1;27(1):472. doi: 10.1186/s13054-023-04715-z.
- Derived from this study: PubMed 36251223Ziriat I, Le Thuaut A, Colin G, Merdji H, Grillet G, Girardie P, Souweine B, Dequin PF, Boulain T, Frat JP, Asfar P, Francois B, Landais M, Plantefeve G, Quenot JP, Chakarian JC, Sirodot M, Legriel S, Massart N, Thevenin D, Desachy A, Delahaye A, Botoc V, Vimeux S, Martino F, Reignier J, Cariou A, Lascarrou JB. Outcomes of mild-to-moderate postresuscitation shock after non-shockable cardiac arrest and association with temperature management: a post hoc analysis of HYPERION trial data. Ann Intensive Care. 2022 Oct 17;12(1):96. doi: 10.1186/s13613-022-01071-z.
- Derived from this study: PubMed 31577396Lascarrou JB, Merdji H, Le Gouge A, Colin G, Grillet G, Girardie P, Coupez E, Dequin PF, Cariou A, Boulain T, Brule N, Frat JP, Asfar P, Pichon N, Landais M, Plantefeve G, Quenot JP, Chakarian JC, Sirodot M, Legriel S, Letheulle J, Thevenin D, Desachy A, Delahaye A, Botoc V, Vimeux S, Martino F, Giraudeau B, Reignier J; CRICS-TRIGGERSEP Group. Targeted Temperature Management for Cardiac Arrest with Nonshockable Rhythm. N Engl J Med. 2019 Dec 12;381(24):2327-2337. doi: 10.1056/NEJMoa1906661. Epub 2019 Oct 2.
- Derived from this study: PubMed 25882712Lascarrou JB, Meziani F, Le Gouge A, Boulain T, Bousser J, Belliard G, Asfar P, Frat JP, Dequin PF, Gouello JP, Delahaye A, Hssain AA, Chakarian JC, Pichon N, Desachy A, Bellec F, Thevenin D, Quenot JP, Sirodot M, Labadie F, Plantefeve G, Vivier D, Girardie P, Giraudeau B, Reignier J; Clinical Research in Intensive Care and Sepsis (CRICS) Group and HYPERION Study Group. Therapeutic hypothermia after nonshockable cardiac arrest: the HYPERION multicenter, randomized, controlled, assessor-blinded, superiority trial. Scand J Trauma Resusc Emerg Med. 2015 Mar 7;23:26. doi: 10.1186/s13049-015-0103-5.
- Related InfoLink provided by the sponsor.
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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.
Jean Baptiste Lascarrou, MD study chair
Nantes University Hospital
26 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Cardiac Arrest, run by Centre Hospitalier Departemental Vendee at 26 sites in 2 countries.
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 2 inclusion and 10 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 16 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in France, Guadeloupe. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Neurological outcome assessed with Cerebral Performance Category scale (time frame: Day 90). 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 NCT01994772, which also lists 4 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 16 Jan 2019.