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Ventricular Arrhythmias and Cardiac ArrestPhase 3PARACANCT06835491

Prophylactic Anti-aRrhythmic Therapy With Amiodarone in Critically Ill Patients Admitted for an Out-of-hospital Cardiac Arrest With Initial Shockable Rhythm

A Phase 3 study testing Amiodarone in people with Ventricular Arrhythmias and Cardiac Arrest, run by Versailles Hospital at 29 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

To 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Amiodarone
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
674 participants
Where
29 sitesFrance
Study dates
6 Nov 2025to 15 Mar 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Cardiac arrest secondary to an extra-cardiac cause (suspected or confirmed)
  • Indication for amiodarone decided by the physician at ICU admission
  • No central venous catheter available for continuous infusion of amidoarone
  • Thyroid disease under treatment
  • History of cardiac conduction disorders, not treated by permanent pacemaker
  • Any contra indication to amiodarone treatment
Show all 14Show fewer
  • Refractory ventricular arrhythmia or electrical storm
  • Need for veno-arterial extracorporeal membrane oxygenation (VA-ECMO) at admission
  • Known limitations in therapy and Do Not Resuscitate-order
  • Moribund patient due to pre-arrest history (estimated life expectancy < 3 months)
  • Pregnant or breastfeeding women
  • Patient needing a nadolol treatment due to QT long syndrome or catecholaminergic polymorphic ventricular tachycardia
  • Patient with known pulmonary fibrosis
  • Patient with known interstitial lung disease

Trial locations and contacts

29 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Sandrine Roux contact

0139239777

sroux@ght78sud.fr

29 sites in 1 country

France29 sites, 29 recruiting

  • Chu Amiens

    Amiens

    julien maizel, md

    Not yet recruiting

  • Chu Angers

    Angers

    pierre asfar, MD

    Recruiting

  • CH annecy genevois

    Annecy

    davis bougon, md

    Recruiting

  • Ch Argenteuil

    Argenteuil

    gaetan plantefeve, md

    Recruiting

  • CH Mondor

    Aurillac

    Emanuele turbil, MD

    Recruiting

  • CHU Brest

    Brest

    pierre bailly, MD

    Recruiting

  • CH Brive

    Brive-la-Gaillarde

    cédric barucchi, MD

    Recruiting

  • Chu Caen

    Caen

    cédric daubin, MD

    Not yet recruiting

  • Chi Nord Ardennes

    Charleville-Mézières

    jérémy rosman, MD

    Recruiting

  • CHSF

    Corbeil-Essonnes

    sophie marques, md

    Recruiting

  • CHD vendée

    La Roche-sur-Yon

    gwenhael colin, MD

    Recruiting

  • CH la rochelle

    La Rochelle

    francois perrier, MD

    Recruiting

  • Hcl

    Lyon

    jean christophe richard, MD

    Recruiting

  • Ap Hm

    Marseille

    jeremy bourenne

    Recruiting

  • Hopital Cartier

    Massy

    wulfran bougouin, md

    Recruiting

  • chi Gregoire

    Montreuil

    vincent das, MD

    Not yet recruiting

  • Hoptial Mulhouse

    Mulhouse

    guylaine labro, md

    Recruiting

  • CHU Nantes

    Nantes

    jean baptiste lascarrou, MD

    Not yet recruiting

  • Clinique Ambroise Paré

    Neuilly-sur-Seine

    guillaume geri, md

    Recruiting

  • CHU Nice -MIR Archet

    Nice

    mathieu jozwiak

    Recruiting

  • CHU Nice -MIR Pasteur

    Nice

    denis doyen, MD

    Recruiting

  • Chu Orléans

    Orléans

    grégoire muller, MD

    Recruiting

  • CHU Cochin

    Paris

    alain coriou, MD

    Recruiting

  • Hopital saint joseph

    Paris

    cedric bruel, MD

    Recruiting

  • CHU Poitiers

    Poitiers

    florence boissier, MD

    Recruiting

  • Chu Strasbourg

    Strasbourg

    antoine studer, md

    Recruiting

  • CHI Toulon

    Toulon

    noemie peres, MD

    Recruiting

  • Chu Toulouse

    Toulouse

    clement delmas, md

    Recruiting

  • CH Cotentin

    Valognes

    julien calus, MD

    Recruiting

Other trials in France

About this study

Official title: Prophylactic Anti-aRrhythmic Therapy With Amiodarone in Critically Ill Patients Admitted for an Out-of-hospital Cardiac Arrest With Initial Shockable Rhythm.

To 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)

Being tested
Amiodarone
Medical subject headings
Heart Arrest

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AmiodaroneDrug

    Initial loading dose of 300mg over 30 minutes in 250ml of glucose 5% solution. Continuous amiodarone infusion will be administered for 72 hours at a dose of 10 mg/kg without exceeding 900 mg/24h.

Study groups in NCT06835491
Study groupRoleWhat they receive
AmiodaroneExperimentalInitial loading dose of 300mg over 30 minutes in 250ml of glucose 5% solution. Continuous amiodarone infusion will be administered for 72 hours at a dose of 10 mg/kg without exceeding 900 mg/24h.
Receives: Drug: Amiodarone
ControlNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of Mortality and severe ventricular arrhythmia

    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).

    Measured: 30 days

Secondary outcomes (10)

  1. outcomes related with cardiac events

    • Occurrence of ventricular fibrillation (VF)
    • Occurrence of ventricular tachycardia (VT) requiring or not intervention
    • Occurrence of atrial fibrillation (AF) and supraventricular tachycardia
    • Occurrence of cardiac re-arrest due to asystole

    Measured: 90 days

  2. outcomes related with mortality

    • ICU mortality
    • Hospital (and 30-day) mortality
    • Day 90 mortality

    Measured: 90 days

  3. Duration of invasive mechanical ventilation

    Measured: 90 days

  4. Number of participants with outcomes related with amiodorane side effects

    Number of the following side effects, patients could experimente (if applicable) during amiodarone infusion:

    • Conduction disorders
    • Hemodynamic consequences
    • Hepatic cytolysis
    • Anaphylaxis

    Measured: 5 days

  5. Neurological outcome

    M-Rankin scale (the lowest score is no handicap and the highest score is death) and Glasgow Outcome Score (the lowest score is the most severe coma)

    Measured: 90 days

  6. Duration vasopressor infusion

    Measured: 90 days

  7. Length of ICU stay

    Measured: 90 days

  8. Length of stay in hospital

    Measured: 90 days

  9. Dose of the anti-arrhythmic drugs

    Measured: 90 days

  10. Number of days of anti-arrhythmic drugs

    Measured: 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Feb 2025
  2. Study start6 Nov 2025
  3. Primary completion15 Jan 2027 (estimated)
  4. Study completion15 Mar 2027 (estimated)

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
674 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06835491
Sponsor's protocol ID
P23/08_PARACA
Acronym
PARACA
Status last verified
Dec 2025
First submitted
15 Jan 2025
Last updated
23 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Amiodarone in people with Ventricular Arrhythmias and Cardiac Arrest, run by Versailles Hospital at 29 sites 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 7 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sandrine Roux (0139239777, sroux@ght78sud.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of Mortality and severe ventricular arrhythmia (time frame: 30 days). 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 NCT06835491.

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 23 Dec 2025.

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