Non Shockable Out of Hospital Cardiac ArrestPhase 3CYRUSNCT01595958
Cyclosporine A in Cardiac Arrest
A Phase 3 study testing Cyclosporine A and cardio-pulmonary resuscitation in people with Non Shockable Out of Hospital Cardiac Arrest, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
The investigators hypothesised that cyclosporine A administration at the onset of cardiopulmonary resuscitation, by inhibiting the mitochondrial permeability transition pore, could prevent the post cardiac arrest syndrome and improve outcomes. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Non Shockable Out of Hospital Cardiac Arrest
- What is being tested?
- Cyclosporine A and cardio-pulmonary resuscitation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 796 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2010to Mar 2013
- 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
- Non shockable cardiac rhythm
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
Official title: CYclosporine A in Non-shockable Out-of-hospital Cardiac Arrest ResUScitation
The investigators hypothesised that cyclosporine A administration at the onset of cardiopulmonary resuscitation, by inhibiting the mitochondrial permeability transition pore, could prevent the post cardiac arrest syndrome and improve outcomes.
- Being tested
- Cyclosporine A, cardio-pulmonary resuscitation
- Keywords
- Cardiac arrest, heart arrest, cyclosporine A, post cardiac arrest syndrome, protective agent, multiple organ failure, mitochondrial permeability transition pore, mitochondria, cardio-pulmonary resuscitation, cardioprotection, ischemia reperfusion, postconditioning
- Medical subject headings
- Heart Arrest, Post-Cardiac Arrest Syndrome, Multiple Organ Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cyclosporine ADrug
Single intravenous bolus of cyclosporine A (2.5 mg/kg) at the onset of resuscitation
cardio-pulmonary resuscitationProcedure or surgery
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: Cyclosporine A; Procedure: cardio-pulmonary resuscitation |
| Control | Active comparator | usual care of cardiac arrest Receives: Procedure: cardio-pulmonary resuscitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sequential Organ Failure Assessment score (SOFA)
Measured: At 24 hours after hospital admission
Secondary outcomes (4)
Hospital admission with return of spontaneous circulation
Measured: At 24 hours following admission, at day 28, at hospital discharge (an average time frame of 7 days)
Survival
Measured: At 24 hours following admission, at day 28, and at hospital discharge (an average time frame of 7 days)
Good cerebral outcome
Glasgow Coma Scale and Cerebral Performance Categories
Measured: At 24 hours following admission, at day 28, and at hospital discharge (an average time frame of 7 days)
All adverse events
Measured: until hospital discharge (an average time frame of 7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2012 (estimated)
- Study startJun 2010
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Non 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 796 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurent ARGAUD, MD, PhD, Principal investigator, Groupement Hospitalier Edouard Herriot,69437 Lyon Cedex 03
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01595958
- Sponsor's protocol ID
- 2009.571
- Other IDs
- 2009-015725-37, 2009
- Acronym
- CYRUS
- Status last verified
- Aug 2025
- First submitted
- 30 Apr 2012
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Argaud L, Cour M, Dubien PY, Giraud F, Jossan C, Riche B, Hernu R, Darmon M, Poncelin Y, Tchenio X, Quenot JP, Freysz M, Kamga C, Beuret P, Usseglio P, Badet M, Anette B, Chaulier K, Alasan E, Sadoune S, Bobbia X, Zeni F, Gueugniaud PY, Robert D, Roy P, Ovize M; CYRUS Study Group. Effect of Cyclosporine in Nonshockable Out-of-Hospital Cardiac Arrest: The CYRUS Randomized Clinical Trial. JAMA Cardiol. 2016 Aug 1;1(5):557-65. doi: 10.1001/jamacardio.2016.1701.
PubMed 27433815Madelaine T, Cour M, Roy P, Vivien B, Charpentier J, Dumas F, Deye N, Bonnefoy E, Gueugniaud PY, Coste J, Cariou A, Argaud L. Prediction of Brain Death After Out-of-Hospital Cardiac Arrest: Development and Validation of the Brain Death After Cardiac Arrest Score. Chest. 2021 Jul;160(1):139-147. doi: 10.1016/j.chest.2021.01.056. Epub 2021 Jun 8.
PubMed 34116828
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CYclosporine A in Non-shockable Out-of-hospital Cardiac Arrest ResUScitation
- ClinicalTrials.gov ID
- NCT01595958
- Acronym / sponsor ID
- CYRUS / 2009.571
- Keywords
- Cardiac arrest, heart arrest, cyclosporine A, post cardiac arrest syndrome, protective agent, multiple organ failure, mitochondrial permeability transition pore, mitochondria
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 796 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 10 May 2012 (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.
The investigators hypothesised that cyclosporine A administration at the onset of cardiopulmonary resuscitation, by inhibiting the mitochondrial permeability transition pore, could prevent the post cardiac arrest syndrome and improve outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cyclosporine A | Experimental | Drug: Cyclosporine A, Procedure: cardio-pulmonary resuscitationSingle intravenous bolus of cyclosporine A (2.5 mg/kg) at the onset of resuscitation |
| Control | Active comparator | Procedure: cardio-pulmonary resuscitationusual care of cardiac arrest |
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
- Non shockable cardiac rhythm
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 |
|---|---|---|
| Cyclosporine ASingle intravenous bolus of cyclosporine A (2.5 mg/kg) at the onset of resuscitation | Drug | Cyclosporine A |
| cardio-pulmonary resuscitationusual care of cardiac arrest | Procedure or surgery | Control, Cyclosporine A |
Primary outcome
Sequential Organ Failure Assessment score (SOFA)
Time frame: At 24 hours after hospital admission
4 secondary outcomes
Hospital admission with return of spontaneous circulation
Time frame: At 24 hours following admission, at day 28, at hospital discharge (an average time frame of 7 days)
Survival
Time frame: At 24 hours following admission, at day 28, and at hospital discharge (an average time frame of 7 days)
Good cerebral outcome
Time frame: At 24 hours following admission, at day 28, and at hospital discharge (an average time frame of 7 days)
All adverse events
Time frame: until hospital discharge (an average time frame of 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 28 Aug 2025.
- Results publication: PubMed 27433815Argaud L, Cour M, Dubien PY, Giraud F, Jossan C, Riche B, Hernu R, Darmon M, Poncelin Y, Tchenio X, Quenot JP, Freysz M, Kamga C, Beuret P, Usseglio P, Badet M, Anette B, Chaulier K, Alasan E, Sadoune S, Bobbia X, Zeni F, Gueugniaud PY, Robert D, Roy P, Ovize M; CYRUS Study Group. Effect of Cyclosporine in Nonshockable Out-of-Hospital Cardiac Arrest: The CYRUS Randomized Clinical Trial. JAMA Cardiol. 2016 Aug 1;1(5):557-65. doi: 10.1001/jamacardio.2016.1701.
- Derived from this study: PubMed 34116828Madelaine T, Cour M, Roy P, Vivien B, Charpentier J, Dumas F, Deye N, Bonnefoy E, Gueugniaud PY, Coste J, Cariou A, Argaud L. Prediction of Brain Death After Out-of-Hospital Cardiac Arrest: Development and Validation of the Brain Death After Cardiac Arrest Score. Chest. 2021 Jul;160(1):139-147. doi: 10.1016/j.chest.2021.01.056. Epub 2021 Jun 8.
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, MD, PhD principal investigator
Groupement Hospitalier Edouard Herriot,69437 Lyon Cedex 03
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 Cyclosporine A and cardio-pulmonary resuscitation in people with Non 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: finished, as of the sponsor's last update on 28 Aug 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 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. 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 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?
Sequential Organ Failure Assessment score (SOFA) (time frame: At 24 hours after hospital admission). 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 NCT01595958, which also lists 2 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 28 Aug 2025.