Clinical trial • Cardiology

ISOPRENALINE HYDROCHLORIDE for Cardiac arrest

Clinical trial of ISOPRENALINE HYDROCHLORIDE for Cardiac arrest.

Overview

Trial Therapeutic Area: Cardiology
Trial Disease: Cardiac arrest
Drug Modality: Small molecule

Key dates

Initial CTIS Submission Date: 11-10-2024
First CTIS Authorization Date: 03-02-2025

Trial design

Test: Isoprenaline hydrochloride "Macure" (active substance: ISOPRENALINE HYDROCHLORIDE) - route: INTRAVENOUS BOLUS USE; maximum total dose indicated 2.4 mg. Comparator: Adrenalin "DAK" (active substance: EPINEPHRINE) - route: INTRAVENOUS BOLUS USE; maximum total dose indicated 4 mg.-controlled trial across 2 sites in Denmark.

Comparator: Test: Isoprenaline hydrochloride "Macure" (active substance: ISOPRENALINE HYDROCHLORIDE) - route: INTRAVENOUS BOLUS USE; maximum total dose indicated 2.4 mg. Comparator: Adrenalin "DAK" (active substance: EPINEPHRINE) - route: INTRAVENOUS BOLUS USE; maximum total dose indicated 4 mg.
Target Sample Size: 1178

Eligibility

Recruits 1178 The registry flags vulnerable population selected (isVulnerablePopulationSelected = true). There are multiple Subject Information Sheets and Informed Consent Forms provided for different scenarios including patient ICFs, closest relative ICFs, consent forms for closest relative to deceased, and an "Independent doctor and Legally designated representative Consent Form", indicating procedures for enrolling incapacitated adults via closest relative, legally designated representative or independent doctor. Age-specific assent is not applicable because inclusion requires Age ≥18 years. Languages of consent documents are not specified in the available data..

Pregnancy Exclusion: Known or apparent pregnancy.
Vulnerable Population: The registry flags vulnerable population selected (isVulnerablePopulationSelected = true). There are multiple Subject Information Sheets and Informed Consent Forms provided for different scenarios including patient ICFs, closest relative ICFs, consent forms for closest relative to deceased, and an "Independent doctor and Legally designated representative Consent Form", indicating procedures for enrolling incapacitated adults via closest relative, legally designated representative or independent doctor. Age-specific assent is not applicable because inclusion requires Age ≥18 years. Languages of consent documents are not specified in the available data.

Inclusion criteria

{"criterion_text":"- Men and women with bystander and/or emergency medical service personnel witnessed out-of-hospital cardiac arrest.\n- Age ≥18 years.\n- Initial rhythm non-shockable rhythm (PEA or asystole).\n- Advanced life support initiated or continued by EMS personnel."}

Exclusion criteria

{"criterion_text":"- Cardiac arrest caused by or suspected to be caused by blunt trauma, penetrating trauma, or burn injury.\n- Cardiac arrest caused by or suspected to be caused by drowning, hanging, strangulation, and foreign body airway obstruction.\n- IV epinephrine already administered prior to EMS arrival.\n- Prior enrollment in the trial.\n- Patient with cardiac arrest at nursing homes.\n- Known or apparent pregnancy."}

Endpoints

Primary endpoints

{"endpoint_text":"- Sustained return of spontaneous circulation of at least 20 minutes.","definition_or_measurement_approach":"Sustained return of spontaneous circulation (ROSC) defined as ROSC lasting at least 20 minutes."}

Secondary endpoints

{"endpoint_text":"- Conversion from non-shockable to shockable rhythm","definition_or_measurement_approach":""}
{"endpoint_text":"- Favorable neurological outcome at hospital discharge","definition_or_measurement_approach":""}
{"endpoint_text":"- ROSC at hospital arrival","definition_or_measurement_approach":""}
{"endpoint_text":"- Thirty-day survival","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size: 1178
Recruitment Window Months: 42
Consent Approach: Adult participants (age ≥18) provide informed consent where possible. For incapacitated adults, the documentation includes forms for closest relative consent, legally designated representative, and an independent doctor consent form. Multiple ICF/SIS documents and biobank consent forms are provided (patient, closest relative, closest relative to deceased, independent doctor/LDR). Specific languages of the consent documents are not stated in the available data.

Geography

Total Number Of Sites: 2
Total Number Of Participants: 1178

Denmark

Earliest CTIS Part Ii Submission Date: 07-12-2024
Latest Decision Or Authorization Date: 03-02-2025
Processing Time Days: 58
Number Of Sites: 2
Number Of Participants: 1178

Sites

Site Name: Odense University Hospital
Department Name: Kardiologisk Forskningsenhed
Contact Person Name: Laura Sarkisian
Contact Person Email: Laura.Sarkisian2@rsyd.dk

Site Name: Rigshospitalet
Department Name: Hjertecentret
Contact Person Name: Christian Hassager
Contact Person Email: christian.hassager@regionh.dk

Sponsor

Primary sponsor

Full Name: Odense University Hospital
Organisation Type: Hospital/Clinic/Other health care facility
Country Of Registered Address: Denmark

Third parties

{"country":"Denmark","full_name":"Odense University Hospital","duties_or_roles":"sponsorDuties codes: 1, 7, 8","organisation_type":"Hospital/Clinic/Other health care facility"}

Investigational products

Investigational Product Name: Isoprenaline hydrochloride "Macure", koncentrat til infusionsvæske, opløsning
Active Substance: ISOPRENALINE HYDROCHLORIDE
Modality: Small molecule
Routes Of Administration: INTRAVENOUS BOLUS USE
Route: INTRAVENOUS BOLUS USE
Authorisation Status: Marketing authorisation available (marketingAuthNumber 62257; authorisationCountryCode DK)
Maximum Dose: 2.4 mg

Investigational Product Name: Adrenalin "DAK", injektionsvæske, opløsning
Active Substance: EPINEPHRINE
Modality: Small molecule
Routes Of Administration: INTRAVENOUS BOLUS USE
Route: INTRAVENOUS BOLUS USE
Authorisation Status: Marketing authorisation available (marketingAuthNumber 07014; authorisationCountryCode DK)
Maximum Dose: 4 mg

Related trials

Other published trials that may interest you.