Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Not authorised
Participants planned
1,178
Countries
1
Sites
2
Cardiac arrest
To determine whether the use of isoprenaline increases the chance of sustained return of spontaneous circulation during out-of-hospital cardiac arrest with non-shockable rhythm compared with epinephrine.
Key facts
- Sponsor
- Odense University Hospital
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Decision date (initial)
- 2025-02-03
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-516074-29-00
- ClinicalTrials.gov
- NCT06473116
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Safety, Efficacy
To determine whether the use of isoprenaline increases the chance of sustained return of spontaneous circulation during out-of-hospital cardiac arrest with non-shockable rhythm compared with epinephrine.
Secondary objectives 4
- To evaluate whether the use of isoprenaline can increase the rate of conversions from non-shockable to a shockable heart rhythm in patients with out-of-hospital cardiac arrest compared with epinephrine.
- To evaluate whether the use of isoprenaline improves the chance of good neurological outcome at discharge in patients with out-of-hospital cardiac arrest compared with epinephrine.
- To evaluate whether the use of isoprenaline can increase the chance of achieving sustained return of spontaneous circulation and improving 30-day survival after out-of-hospital cardiac arrest compared with epinephrine.
- To evaluate how the use of isoprenaline affects neurological outcome 90 days after the out-of-hospital cardiac arrest compared with epinephrine
Conditions and MedDRA coding
Cardiac arrest
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10007515 | Cardiac arrest | 100000004849 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Men and women with bystander and/or emergency medical service personnel witnessed out-of-hospital cardiac arrest.
- Age ≥18 years.
- Initial rhythm non-shockable rhythm (PEA or asystole).
- Advanced life support initiated or continued by EMS personnel.
Exclusion criteria 6
- Cardiac arrest caused by or suspected to be caused by blunt trauma, penetrating trauma, or burn injury.
- Cardiac arrest caused by or suspected to be caused by drowning, hanging, strangulation, and foreign body airway obstruction.
- IV epinephrine already administered prior to EMS arrival.
- Prior enrollment in the trial.
- Patient with cardiac arrest at nursing homes.
- Known or apparent pregnancy.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Sustained return of spontaneous circulation of at least 20 minutes.
Secondary endpoints 4
- Conversion from non-shockable to shockable rhythm
- Favorable neurological outcome at hospital discharge
- ROSC at hospital arrival
- Thirty-day survival
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Isoprenaline hydrochloride "Macure", koncentrat til infusionsvæske, opløsning
PRD8332194 · Product
- Active substance
- Isoprenaline Hydrochloride
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS BOLUS USE
- Max daily dose
- 2.4 mg milligram(s)
- Max total dose
- 2.4 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- C01CA02 — ISOPRENALINE
- Marketing authorisation
- 62257
- MA holder
- MACURE PHARMA APS
- MA country
- Denmark
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 1
Adrenalin "DAK", injektionsvæske, opløsning
PRD11461564 · Product
- Active substance
- Epinephrine
- Substance synonyms
- Adrenaline, ADRENALINUM
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS BOLUS USE
- Max daily dose
- 4 mg milligram(s)
- Max total dose
- 4 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- C01CA24 — EPINEPHRINE
- Marketing authorisation
- 07014
- MA holder
- ORIFARM HEALTHCARE A/S
- MA country
- Denmark
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Odense University Hospital
- Sponsor organisation
- Odense University Hospital
- Address
- J B Winsloews Vej 4
- City
- Odense C
- Postcode
- 5000
- Country
- Denmark
Scientific contact point
- Organisation
- Odense University Hospital
- Contact name
- Research Department of Cardiology
Public contact point
- Organisation
- Odense University Hospital
- Contact name
- Research Department of Cardiology
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Odense University Hospital ORG-100007716
|
Odense C, Denmark | On site monitoring, E-data capture, Code 8 |
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Not authorised | 1,178 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
Odense University Hospital
Kardiologisk Forskningsenhed, J B Winsloews Vej 4, 5000, Odense C
Rigshospitalet
Hjertecentret, Blegdamsvej 9, 2100, Copenhagen Oe
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 15 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_ Protocol 2024-516074-29-00 | 3 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements EPISO | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Closest relative Biobank OUH | 3 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Closest relative Biobank RH | 3 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Closest relative Consent form OUH | 3 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Closest relative Consent form RH | 3 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Independent doctor and Legally designated representative Consent Form | 3 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Patient Biobank OUH | 3 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Patient Biobank RH | 3 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Patient Consent form OUH | 3 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Patient Consent form RH | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Closest relative to deceased OUH-RH | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_ SmPC Adrenaline | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_ SmPC Isoprenaline Hydrochloride | 1 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_ENG 2024-516074-29-00 | 2 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-11 | Denmark | Not acceptable 2025-01-28
|
2025-02-03 |