Cyclosporine A in Cardiac Arrest

NCT ID: NCT01595958

Last Updated: 2025-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

796 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2013-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Non Shockable Out of Hospital Cardiac Arrest

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Cyclosporine A

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

Group Type EXPERIMENTAL

Cyclosporine A

Intervention Type DRUG

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

cardio-pulmonary resuscitation

Intervention Type PROCEDURE

usual care of cardiac arrest

Control

usual care of cardiac arrest

Group Type ACTIVE_COMPARATOR

cardio-pulmonary resuscitation

Intervention Type PROCEDURE

usual care of cardiac arrest

Interventions

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Cyclosporine A

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

Intervention Type DRUG

cardio-pulmonary resuscitation

usual care of cardiac arrest

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Evidence of trauma
* Evidence of pregnancy
* Duration of no flow more than 30 minutes
* Rapidly fatal underlying disease
* Allergy to cyclosporin A
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Laurent ARGAUD, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Groupement Hospitalier Edouard Herriot,69437 Lyon Cedex 03

Locations

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Medical intensive care unit, Edouard Herriot Hospital

Lyon, , France

Site Status

Countries

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France

References

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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.

Reference Type RESULT
PMID: 27433815 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34116828 (View on PubMed)

Other Identifiers

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2009-015725-37

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2009.571

Identifier Type: -

Identifier Source: org_study_id

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