NCT01595958

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
796

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jun 2010

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

April 30, 2012

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 10, 2012

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

August 28, 2025

Status Verified

August 1, 2025

Enrollment Period

2.8 years

First QC Date

April 30, 2012

Last Update Submit

August 21, 2025

Conditions

Non Shockable Out of Hospital Cardiac Arrest

Keywords

Cardiac arrestheart arrestcyclosporine Apost cardiac arrest syndromeprotective agentmultiple organ failuremitochondrial permeability transition poremitochondriacardio-pulmonary resuscitationcardioprotectionischemia reperfusionpostconditioning

Outcome Measures

Primary Outcomes (1)

  • Sequential Organ Failure Assessment score (SOFA)

    At 24 hours after hospital admission

Secondary Outcomes (4)

  • Hospital admission with return of spontaneous circulation

    At 24 hours following admission, at day 28, at hospital discharge (an average time frame of 7 days)

  • Survival

    At 24 hours following admission, at day 28, and at hospital discharge (an average time frame of 7 days)

  • Good cerebral outcome

    At 24 hours following admission, at day 28, and at hospital discharge (an average time frame of 7 days)

  • All adverse events

    until hospital discharge (an average time frame of 7 days)

Study Arms (2)

Cyclosporine A

EXPERIMENTAL

Single intravenous bolus of cyclosporine A (2.5 mg/kg) at the onset of resuscitation

Drug: Cyclosporine AProcedure: cardio-pulmonary resuscitation

Control

ACTIVE COMPARATOR

usual care of cardiac arrest

Procedure: cardio-pulmonary resuscitation

Interventions

Cyclosporine ADRUG

Single intravenous bolus of cyclosporine A (2.5 mg/kg) at the onset of resuscitation

Cyclosporine A
cardio-pulmonary resuscitationPROCEDURE

usual care of cardiac arrest

ControlCyclosporine A

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Witnessed out-of-hospital cardiac arrest
  • Non shockable cardiac rhythm

You may not qualify if:

  • Evidence of trauma
  • Evidence of pregnancy
  • Duration of no flow more than 30 minutes
  • Rapidly fatal underlying disease
  • Allergy to cyclosporin A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical intensive care unit, Edouard Herriot Hospital

Lyon, 69003, France

Location

Related Publications (2)

  • 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.

    PMID: 27433815RESULT

  • Madelaine 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.

    PMID: 34116828DERIVED

MeSH Terms

Conditions

Heart ArrestPost-Cardiac Arrest SyndromeMultiple Organ Failure

Interventions

CyclosporineCardiopulmonary Resuscitation

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesBrain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesReperfusion InjuryVascular DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Intervention Hierarchy (Ancestors)

CyclosporinsPeptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and ProteinsResuscitationEmergency TreatmentTherapeutics

Study Officials

  • Laurent ARGAUD, MD, PhD

    Groupement Hospitalier Edouard Herriot,69437 Lyon Cedex 03

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2012

First Posted

May 10, 2012

Study Start

June 1, 2010

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

August 28, 2025

Record last verified: 2025-08

Locations

FR(1)