Shockable Out of Hospital Cardiac ArrestPhase 3CYRUS IINCT02887807
CYclosporine A in Shockable Out-of-hospital Cardiac Arrest ResUScitation
A Phase 3 study testing Single intravenous bolus of cyclosporine A (2.5 mg/kg) at the onset of resuscitation in people with Shockable Out of Hospital Cardiac Arrest, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Cardiac arrest (CA) is a public health problem in industrialized countries. The prognosis of these patients remains poor with significant mortality and severe neurological sequelae in survivors. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Shockable Out of Hospital Cardiac Arrest
- What is being tested?
- Single intravenous bolus of cyclosporine A (2.5 mg/kg) at the onset of resuscitation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2017to Jan 2019
- Phase
- Phase 3
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Witnessed out-of-hospital cardiac arrest
- Shockable cardiac rhythm at first medical contact (ventricular fibrillation, ventricular tachycardia)
Who cannot join
- Evidence of trauma
- Evidence of pregnancy
- Duration of no flow more than 30 minutes
- Rapidly fatal underlying disease
- Allergy to cyclosporin A
Trial locations and contacts
1 site in 1 country.
About this study
Cardiac arrest (CA) is a public health problem in industrialized countries. The prognosis of these patients remains poor with significant mortality and severe neurological sequelae in survivors.
The objective of the present study is to determine whether cyclosporine can improve patient clinical outcome after shockable CA. 520 patients with CA will be entered into a multicentre, randomized, placebo-controlled study. They will receive one single injection of cyclosporine (or placebo) prior to resuscitation. The incidence of the combined endpoint (mortality, irreversible brain damage informations such as bilateral abolition of N20 wave or absent motor response or extension to the nociceptive stimulation…) will be assessed 7 days after CA.
- Conditions
- Shockable Out of Hospital Cardiac Arrest
- Being tested
- Single intravenous bolus of cyclosporine A (2.5 mg/kg) at the onset of resuscitation, Single intravenous bolus of placebo at the onset of resuscitation
- Keywords
- Cardiac arrest, Shockable, Cyclosporine
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single intravenous bolus of cyclosporine A (2.5 mg/kg) at the onset of resuscitationDrug
cardio-pulmonary resuscitation usual care of cardiac arrest
Single intravenous bolus of placebo at the onset of resuscitationDrug
cardio-pulmonary resuscitation usual care of cardiac arrest
| Study group | Role | What they receive |
|---|---|---|
| Cyclosporine A | Experimental | Single intravenous bolus of cyclosporine A (2.5 mg/kg) at the onset of resuscitation Receives: Drug: Single intravenous bolus of cyclosporine A (2.5 mg/kg) at the onset of resuscitation |
| Control | Placebo comparator | Single intravenous bolus of placebo (2.5 mg/kg) at the onset of resuscitation Receives: Drug: Single intravenous bolus of placebo at the onset of resuscitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Combined incidence of all-cause mortality and irreversible brain damage status
the presence of irreversible brain damage is defined by the bilateral abolition of the N20 wave on somatosensory evoked potentials recordings or the absence of motor response or extension to painful stimuli on the Glasgow Coma Scale.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2016 (estimated)
- Study startJan 2017
- Primary completionJan 2019 (estimated)
- Study completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shockable Out of Hospital Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurent Argaud, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02887807
- Sponsor's protocol ID
- 2012-753
- Acronym
- CYRUS II
- Status last verified
- Mar 2019
- First submitted
- 18 Aug 2016
- Last updated
- 14 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CYclosporine A in Shockable Out-of-hospital Cardiac Arrest ResUScitation
- ClinicalTrials.gov ID
- NCT02887807
- Acronym / sponsor ID
- CYRUS II / 2012-753
- Conditions
- Shockable Out of Hospital Cardiac Arrest
- Keywords
- Cardiac arrest, Shockable, Cyclosporine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 2 Sep 2016 (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 (CA) is a public health problem in industrialized countries. The prognosis of these patients remains poor with significant mortality and severe neurological sequelae in survivors.
The objective of the present study is to determine whether cyclosporine can improve patient clinical outcome after shockable CA. 520 patients with CA will be entered into a multicentre, randomized, placebo-controlled study. They will receive one single injection of cyclosporine (or placebo) prior to resuscitation. The incidence of the combined endpoint (mortality, irreversible brain damage informations such as bilateral abolition of N20 wave or absent motor response or extension to the nociceptive stimulation…) will be assessed 7 days after CA.
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 |
|---|---|---|
| Cyclosporine A | Experimental | Drug: Single intravenous bolus of cyclosporine A (2.5 mg/kg) at the onset of resuscitationSingle intravenous bolus of cyclosporine A (2.5 mg/kg) at the onset of resuscitation |
| Control | Placebo comparator | Drug: Single intravenous bolus of placebo at the onset of resuscitationSingle intravenous bolus of placebo (2.5 mg/kg) at the onset of resuscitation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Witnessed out-of-hospital cardiac arrest
- Shockable cardiac rhythm at first medical contact (ventricular fibrillation, ventricular tachycardia)
Key exclusion criteria (5 listed)
- Evidence of trauma
- Evidence of pregnancy
- Duration of no flow more than 30 minutes
- Rapidly fatal underlying disease
- Allergy to cyclosporin A
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 |
|---|---|---|
| Single intravenous bolus of cyclosporine A (2.5 mg/kg) at the onset of resuscitationcardio-pulmonary resuscitation usual care of cardiac arrest | Drug | Cyclosporine A |
| Single intravenous bolus of placebo at the onset of resuscitationcardio-pulmonary resuscitation usual care of cardiac arrest | Drug | Control |
Primary outcome
Combined incidence of all-cause mortality and irreversible brain damage status
Time frame: 7 days
the presence of irreversible brain damage is defined by the bilateral abolition of the N20 wave on somatosensory evoked potentials recordings or the absence of motor response or extension to painful stimuli on the Glasgow Coma Scale.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2019.
- Individual participant dataSharing planned: No
Related trials for Shockable Out of Hospital Cardiac Arrest
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The Variation in Electrode Configuration for Termination of Out-of-Hospital Rhythms That Are Shockable in Cardiac Arrest Trial
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RecruitingPhase 2/3
Early Double Sequential Defibrillation in Out of Hospital Cardiac Arrest
Out of Hospital Cardiac Arrest, Ventricular Fibrillation
Enrolling by invitationObservational study
A Study on the Impact of a New Canton-Wide First Responder System in Zug, Switzerland, on Survival After Adult Cardiac Arrest-Examining Early Life-Saving Organized Help, Fast Defibrillation, and Improved Outcomes for Out of Hospital Cardiac Arrest
Cardiac Arrest (CA), Cardiac Arrest With Successful Resuscitation
RecruitingPhase 3
Prophylactic Anti-aRrhythmic Therapy With Amiodarone in Critically Ill Patients Admitted for an Out-of-hospital Cardiac Arrest With Initial Shockable Rhythm
Ventricular Arrhythmias and Cardiac Arrest
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.
Laurent Argaud principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Single intravenous bolus of cyclosporine A (2.5 mg/kg) at the onset of resuscitation in people with Shockable Out of Hospital Cardiac Arrest, run by Hospices Civils de Lyon at 1 site in France.
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 5 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: withdrawn, as of the sponsor's last update on 14 Mar 2019. 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 France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Combined incidence of all-cause mortality and irreversible brain damage status (time frame: 7 days). 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 14 Mar 2019.