Prophylactic Anti-aRrhythmic therapy with Amiodarone in critically ill patients admitted for an out-of-hospital Cardiac Arrest with initial shockable rhythm._PARACA

2023-510099-30-00 Protocol PARACA_P23/08 Therapeutic confirmatory (Phase III) Ongoing, recruiting

Start 23 Sep 2025 · Status Ongoing, recruiting · 1 EU/EEA countries · 28 sites · Protocol PARACA_P23/08

Overview

Sponsor-declared trial summary

Phase Therapeutic confirmatory (Phase III)
Status Ongoing, recruiting
Participants planned 674
Countries 1
Sites 28

Out-of-hospital cardiac arrest with initial shockable rhythm

To comparatively determine if prophylactic administration of amiodarone for 72 hours in critically ill patients admitted after an OHCA with shockable rhythm, with a confirmed or a presumed cardiac cause, decreases the incidence of a composite endpoint of 30-day (starting from inclusion) all-cause mortality and/or sever…

Key facts

Sponsor
Centre Hospitalier De Versailles
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Cardiovascular Diseases [C14]
Trial duration
23 Sep 2025 → ongoing
Decision date (initial)
2025-01-22
Transition trial
No
Low-intervention
Yes
Rare-disease indication
No
Vulnerable population
Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Prophylaxis

To comparatively determine if prophylactic administration of amiodarone for 72 hours in critically ill patients admitted after an OHCA with shockable rhythm, with a confirmed or a presumed cardiac cause, decreases the incidence of a composite endpoint of 30-day (starting from inclusion) all-cause mortality and/or severe in-hospital ventricular arrhythmia recurrence (ventricular fibrillation and/or ventricular tachycardia requiring intervention including re-arrest)

Secondary objectives 1

  1. To comparatively evaluate the prophylactic administration of amiodarone on outcomes related with cardiac events

Conditions and MedDRA coding

Out-of-hospital cardiac arrest with initial shockable rhythm

VersionLevelCodeTermSystem organ class
20.0 LLT 10003109 Arrest cardiac 10007541

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

  1. Patient aged ≥ 18 years
  2. Admitted in intensive care unit
  3. Out-of-hospital cardiac arrest with initial shockable rhythm
  4. Presumed cardiac or unknown cause
  5. Delay between ROSC and screening for randomisation < 6 hours
  6. Informed consent from the patient or a surrogate or deferred consent
  7. Affiliated to or benefiting from a social insurance

Exclusion criteria 11

  1. Cardiac arrest secondary to an extra-cardiac cause (suspected or confirmed)
  2. Indication for amiodarone decided by the physician at ICU admission
  3. No central venous catheter available for continuous infusion of amiodarone
  4. History of thyroid disease (except for stable, uncomplicated hypothyroidism)
  5. History of cardiac conduction disorders, not treated by permanent pacemaker
  6. Amiodarone allergy
  7. Refractory ventricular arrhythmia or electrical storm
  8. Need for veno-arterial extracorporeal membrane oxygenation (VA-ECMO) at admission
  9. Known limitations in therapy and Do Not Resuscitate-order
  10. Moribund patient due to pre-arrest history (estimated life expectancy < 3 months)
  11. Pregnant or breastfeeding women

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. The primary endpoint is a composite of 30-day (starting from inclusion) all-cause mortality and occurrence of severe in-hospital ventricular arrhythmia, defined by ventricular fibrillation and/or ventricular tachycardia requiring intervention occurring between inclusion and hospital discharge (or 30-day whichever the sooner).

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

CORDARONE 150 mg/3 ml, solution injectable en ampoule (IV)

PRD586661 · Product

Active substance
Amiodarone Hydrochloride
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
INTRAVENOUS BOLUS INJECTION/IV INFUSION
Max daily dose
900 mg milligram(s)
Max total dose
2700 mg milligram(s)
Max treatment duration
3 Day(s)
Authorisation status
Authorised
ATC code
C01BD01 — AMIODARONE
Marketing authorisation
34009 319 997 6 8
MA holder
SANOFI WINTHROP INDUSTRIE
MA country
France
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier De Versailles

7 Total trials 1 Recruiting 3 Ended
Academic / Non-commercial
Sponsor organisation
Centre Hospitalier De Versailles
Address
177 Rue De Versailles
City
Le Chesnay-Rocquencourt
Postcode
78150
Country
France

Scientific contact point

Organisation
Centre Hospitalier De Versailles
Contact name
Project Manager

Public contact point

Organisation
Centre Hospitalier De Versailles
Contact name
Project Manager

Locations

1 EU/EEA country · 28 investigational sites

By country

CountryMS statusPlanned subjectsSites
France Ongoing, recruiting 674 28
Rest of world — 0 —

Investigational sites

France

28 sites · Ongoing, recruiting
Centre Hospitalier Victor Dupouy Argenteuil
Réanimation, 69 rue du lieutenant Colonel Prud'Hon, 95100, Argenteuil
Centre Hospitalier Universitaire De Toulouse
Réanimation, 1 Avenue Du Professeur Jean Poulhes, Tsa 50032, Toulouse Cedex 9
Centre Hospitalier Annecy Genevois
Réanimation, 1 Avenue De L Hopital, Bp 90074 Epagny Metz Tessy, Pringy Cedex
Hospices Civils De Lyon
Réanimation, 103 Grande Rue De La Croix Rousse, 69317, Lyon Cedex 04
GIE Groupe hospitalier Paris Saint-Joseph/Vinci
Réanimation, 185 Rue Raymond Losserand, 75674, Paris Cedex 14
Centre Hospitalier Regional Et Universitaire De Brest
Réanimation, Boulevard Tanguy Prigent, 29200, Brest
Centre Hospitalier Regional De Marseille
Réanimation, 264 Rue Saint Pierre, 13005, Marseille
Centre Hospitalier Sud Francilien
Réanimation, 40 Avenue Serge Dassault, 91100, Corbeil Essonnes
Groupe Hospitalier De La Region De Mulhouse Et Sud Alsace
Réanimation, 20 Avenue Du Docteur Rene Laennec, 68100, Mulhouse
Centre Hospitalier de Charleville-Mézières
Réanimation, 45 avenue de Manchester, 08011, Charleville-Mézières
Centre Hospitalier Universitaire De Nice
Réanimation, 30 Voie Romaine, 06000, Nice
Centre Hospitalier Henri Mondor d'Aurillac
Réanimation, 50 République Avenue, 15000, Aurillac
Centre Medico Chirurgical Ambroise Pare Hartmann
Réanimation, 25 Boulevard Victor Hugo, 92200, Neuilly-Sur-Seine
Centre Hospitalier Groupe Hospitalier De La Rochelle Re Aunis
Réanimation, 1 Rue Du Docteur Schweitzer, 17000, La Rochelle
Centre Hospitalier Universitaire D'Angers
Réanimation, 4 Rue Larrey, 49100, Angers
Centre Hospitalier Public Du Cotentin
Réanimation, 46 Rue Val De Saire, 50100, Cherbourg-En-Cotentin
Les Hopitaux Universitaires De Strasbourg
Réanimation, 1 Place De L Hopital, Cs 80426, Strasbourg Cedex
Centre Hospitalier Universitaire D Orleans
Réanimation, 14 Avenue De L Hopital, Cs 86709, Orleans Cedex 2
Hopital Prive Jacques Cartier
Réanimation, 6 Avenue Du Noyer Lambert, 91300, Massy
Assistance Publique Hopitaux De Paris
Réanimation, 1 Avenue Claude Vellefaux, 75010, Paris
Centre Hospitalier Departemental Vendee
Réanimation, Boulevard Stephane Moreau, 85925, La Roche Sur Yon Cedex 9
Centre Hospitalier Universitaire De Nice
Réanimation, 151 Route De Saint Antoine, 06200, Nice
Centre Hospitalier De Versailles
Réanimation, 177 Rue De Versailles, Le Chesnay, Le Chesnay Rocquencourt
Centre Hospitalier Universitaire De Caen Normandie
Réanimation, Avenue De La Cote De Nacre, 14000, Caen
Centre Hospitalier Universitaire De Poitiers
Réanimation, 2 Rue De La Miletrie, 86000, Poitiers
Centre hospitalier de Brive
Réanimation, 1 boulevard Doct Verlhac, 19312, BRIVE LA GAILLARDE
Centre Hospitalier Universitaire Amiens Picardie
Réanimation, 1 Rond Point Du Pr Christian Cabrol, 80054, Amiens Cedex 1
Centre Hospitalier Intercommunal Toulon / La Seine-Sur-Mer
Réanimation, 54 Rue Henri Sainte Claire Deville, 83100, Toulon

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
France 2025-09-23 2025-11-06

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Corrective measures 1 · Art. 77 CTR

Corrective measure CM-FR-0001

Member state
France
Publication date
2025-01-28
Type
3
Reason
7
Immediate action required
No
Justification
In line with CTR Q&amp;A / point 1.23, the sponsor is asked to submit a substantial modification application in order to update the CTA in line with the documentation approved during the appeal procedure within 10 days after the submission of this corrective measure.

Update : The SM application is no longer needed given that the documents were not modified.

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 12 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) D1_Protocol_2023-510099-30-00_PARACA_Public 1.3
Recruitment arrangements (for publication) K1_Recruitment Arrangement Patient_PARACA 1
Subject information and informed consent form (for publication) L1_SIS_ ICF_PROCHE_PARACA_Public 1.2
Subject information and informed consent form (for publication) L1_SIS_ ICF_PROCHE_TrackChange_04092024_PARACA 1.2
Subject information and informed consent form (for publication) L1_SIS_ICF_Inclusion URGENCE_PARACA_Public 1
Subject information and informed consent form (for publication) L1_SIS_ICF_PATIENT_PARACA_Public 1.2
Subject information and informed consent form (for publication) L1_SIS_ICF_PATIENT_TrackChange_04092024_PARACA 1
Subject information and informed consent form (for publication) L1_SIS_ICF_POURSUITE_PARACA_Public 1.2
Subject information and informed consent form (for publication) L1_SIS_ICF_POURSUITE_TrackChange_04092024_PARACA 1.2
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC_CordaroneIV 1
Synopsis of the protocol (for publication) D1_Resume ENG_2023-510099-30-00_PARACA_Public 1.3
Synopsis of the protocol (for publication) D1_Resume_2023-510099-30-00_PARACA_Public 1.3

Application history

1 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-06-20 France Acceptable
2024-10-07
 2024-10-10

Related clinical trials