CYclosporine A in Shockable Out-of-hospital Cardiac Arrest ResUScitation

Status

Withdrawn

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02887807

Acronym

CYRUS II

Enrollment

Registered

2016-09-02

Start date

2017-01-31

Completion date

2019-01-31

Last updated

2019-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Shockable Out of Hospital Cardiac Arrest

Keywords

Cardiac arrest, Shockable, Cyclosporine

Brief 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. 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.

Interventions

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

cardio-pulmonary resuscitation usual care of cardiac arrest

DRUGSingle intravenous bolus of placebo at the onset of resuscitation

cardio-pulmonary resuscitation usual care of cardiac arrest

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Witnessed out-of-hospital cardiac arrest * Shockable cardiac rhythm at first medical contact (ventricular fibrillation, ventricular tachycardia)

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Combined incidence of all-cause mortality and irreversible brain damage status	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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026