Clinical trial • Phase IV • Cardiology
NORADRENALINE TARTRATE for Acute myocardial infarction with cardiogenic shock
Phase IV trial of NORADRENALINE TARTRATE for Acute myocardial infarction with cardiogenic shock.
Overview
- Trial Therapeutic Area
- Cardiology
- Trial Disease
- Acute myocardial infarction with cardiogenic shock
- Trial Stage
- Phase IV
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 16-01-2024
- First CTIS Authorization Date
- 19-02-2024
Trial design
Randomised, open-label, standard care (standard blood pressure target and usual noradrenaline use) versus a strategy of reduced use of noradrenaline; no specific doses or schedules are specified in the dataset.-controlled Phase IV trial in Netherlands, Slovenia, Greece and others.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Standard care (standard blood pressure target and usual noradrenaline use) versus a strategy of reduced use of noradrenaline; no specific doses or schedules are specified in the dataset.
- Target Sample Size
- 918
- Trial Duration For Participant
- 30
Eligibility
Recruits 918 Vulnerable population selected. Subject information sheets and informed consent forms are provided for patients and relatives, and specific ICF documents for trial guardian and next-of-kin (including 'L1_ ICF trial guardian Danish' and 'L1_ ICF Next of kin deceased Danish') are listed in the submission. Documents are available in multiple languages (examples in the file list: English, Greek, Danish, Czech, Swedish, Dutch, French, German), indicating consent/assent and proxy/relative/guardian consent procedures are in place where appropriate..
- Vulnerable Population
- Vulnerable population selected. Subject information sheets and informed consent forms are provided for patients and relatives, and specific ICF documents for trial guardian and next-of-kin (including 'L1_ ICF trial guardian Danish' and 'L1_ ICF Next of kin deceased Danish') are listed in the submission. Documents are available in multiple languages (examples in the file list: English, Greek, Danish, Czech, Swedish, Dutch, French, German), indicating consent/assent and proxy/relative/guardian consent procedures are in place where appropriate.
Inclusion criteria
- {"criterion_text":"- Acute myocardial infarction, STEMI or NSTEMI\n- Early revascularization by PCI\n- Cardiogenic shock, characterized by: I. a. Systolic blood pressure (SBP) < 90 mmHg for > 30 minutes, OR b. Use of drugs to maintain SBP > 90 mmHg at presentation before randomization. II. Clinical signs of impaired organ perfusion with at least one of the following criteria: a. Altered mental status b. Cold, clammy skin and extremities c. Oliguria with urine output < 30ml/hour d. Serum lactate > 2.0 mmol/L III. Clinical signs of pulmonary congestion"}
Exclusion criteria
- {"criterion_text":"- Resuscitation > 30 minutes\n- Mechanical cause of cardiogenic shock (e.g. papillary muscle rupture, ventricular septal rupture)\n- Onset of shock > 12 hours\n- Imminent need for mechanical circulatory support (i.e. ECPR patients)\n- Women < 45 years"}
Endpoints
Primary endpoints
- {"endpoint_text":"- The primary endpoint of the study is the composite of all-cause mortality and severe renal failure requiring renal replacement therapy within 30 days after randomization.","definition_or_measurement_approach":"Composite endpoint measured within 30 days after randomization: occurrence of all-cause mortality or severe renal failure defined as requiring renal replacement therapy."}
Secondary endpoints
- {"endpoint_text":"- All-cause mortality at 30 days\n- Days alive and out of hospital (30 days)","definition_or_measurement_approach":"All-cause mortality measured at 30 days post-randomization; days alive and out of hospital measured over the 30-day period post-randomization."}
Recruitment
- Planned Sample Size
- 918
- Recruitment Window Months
- 46
- Consent Approach
- Informed consent is obtained using subject information sheets and informed consent forms for patients and relatives. Specific consent documents for trial guardians and next-of-kin (including 'trial guardian' and 'Next of kin deceased' forms) are provided. Consent documents are available in multiple languages (English, Greek, Danish, Czech, Swedish, Dutch, French, German as indicated by the listed L1 documents). Proxy/guardian and relative consent pathways are included for participants lacking capacity.
Geography
- Total Number Of Sites
- 26
- Total Number Of Participants
- 918
Netherlands
- Earliest CTIS Part Ii Submission Date
- 30-01-2024
- Latest Decision Or Authorization Date
- 06-10-2025
- Processing Time Days
- 614
- Number Of Sites
- 13
- Number Of Participants
- 661
Sites
- Site Name
- Leids Universitair Medisch Centrum (LUMC)
- Department Name
- Cardiology
- Contact Person Name
- José Montero
- Contact Person Email
- b.a.hoogland@lumc.nl
- Site Name
- Elisabeth-Tweesteden Ziekenhuis
- Department Name
- Cardiology
- Contact Person Name
- Pascalle Monraats
- Contact Person Email
- rvalphen@tsz.nl
- Site Name
- Amsterdam UMC
- Department Name
- Cardiology
- Contact Person Name
- José Henriques
- Contact Person Email
- ctis@amsterdamumc.nl
- Site Name
- Universitair Medisch Centrum Utrecht
- Department Name
- Cardiology
- Contact Person Name
- Adriaan Kraaijeveld
- Contact Person Email
- A.O.Kraaijeveld-3@umcutrecht.nl
- Site Name
- Sint Antonius Ziekenhuis Stichting
- Department Name
- Cardiology
- Contact Person Name
- Krischan Sjauw
- Contact Person Email
- k.sjauw@antoniusziekenhuis.nl
- Site Name
- Medisch Centrum Leeuwarden B.V.
- Department Name
- Cardiology
- Contact Person Name
- Joost Haeck
- Contact Person Email
- Wetenschap@mclacademie.nl
- Site Name
- Medisch Spectrum Twente
- Department Name
- Intensive care
- Contact Person Name
- Alexander Cornet
- Contact Person Email
- ResearchOC@mst.nl
- Site Name
- Catharina Ziekenhuis Stichting
- Department Name
- Intensive care
- Contact Person Name
- Luuk Otterspoor
- Contact Person Email
- luuk.otterspoor@catharinaziekenhuis.nl
- Site Name
- Haga Hospital
- Department Name
- Intensive care
- Contact Person Name
- Sakir Akin
- Contact Person Email
- s.akin@hagaziekenhuis.nl
- Site Name
- Rijnstate Ziekenhuis Stichting
- Department Name
- Cardiology
- Contact Person Name
- Ron Pisters
- Contact Person Email
- RPisters@Rijnstate.nl
- Site Name
- Maasstad Ziekenhuis Stichting
- Department Name
- Intensive care
- Contact Person Name
- Corstiaan den Uil
- Contact Person Email
- uilc@maasstadziekenhuis.nl
- Site Name
- VUmc Stichting
- Department Name
- Cardiology
- Contact Person Name
- Niels Verouden
- Contact Person Email
- c.verouden@amsterdamumc.nl
- Site Name
- Universitair Medisch Centrum Groningen
- Department Name
- Cardiology
- Contact Person Name
- Erik Lipsic
- Contact Person Email
- e.lipsic@umcg.nl
Slovenia
- Earliest CTIS Part Ii Submission Date
- 01-08-2024
- Latest Decision Or Authorization Date
- 13-10-2025
- Processing Time Days
- 439
- Number Of Sites
- 2
- Number Of Participants
- 40
Sites
- Site Name
- UNIVERZITETNI KLINICNI CENTER MARIBOR
- Department Name
- Intensive care
- Contact Person Name
- Jure Fluher
- Contact Person Email
- jfluher@gmail.com
- Site Name
- University Medical Center Ljubljana
- Department Name
- Intensive care
- Contact Person Name
- Tomaz Goslar
- Contact Person Email
- tomaz.goslar@kclj.si
Greece
- Earliest CTIS Part Ii Submission Date
- 18-02-2025
- Latest Decision Or Authorization Date
- 09-10-2025
- Processing Time Days
- 233
- Number Of Sites
- 1
- Number Of Participants
- 20
Sites
- Site Name
- General Hospital Asklepeion Voula
- Department Name
- Cardiology
- Contact Person Name
- Andreas Triantafyllis
- Contact Person Email
- andreas.triantafyllis@gmail.com
Czechia
- Earliest CTIS Part Ii Submission Date
- 28-03-2025
- Latest Decision Or Authorization Date
- 08-10-2025
- Processing Time Days
- 194
- Number Of Sites
- 1
- Number Of Participants
- 12
Sites
- Site Name
- Vseobecna Fakultni Nemocnice V Praze
- Department Name
- Cardiology and intensive care
- Contact Person Name
- Jan Belohlavek
- Contact Person Email
- jan.belohlavek@vfn.cz
Germany
- Earliest CTIS Part Ii Submission Date
- 07-08-2024
- Latest Decision Or Authorization Date
- 08-10-2025
- Processing Time Days
- 427
- Number Of Sites
- 2
- Number Of Participants
- 20
Sites
- Site Name
- Universitaetsklinikum Mannheim GmbH
- Department Name
- Cardiology
- Contact Person Name
- Ibrahim Akin
- Contact Person Email
- ibrahim.akin@umm.de
- Site Name
- Universitaetsklinikum Duesseldorf AöR
- Department Name
- Cardiology, pneumonology and vascular diseases
- Contact Person Name
- Christian Jung
- Contact Person Email
- christian.jung@med.uni-duesseldorf.de
Norway
- Earliest CTIS Part Ii Submission Date
- 27-02-2025
- Latest Decision Or Authorization Date
- 13-10-2025
- Processing Time Days
- 228
- Number Of Sites
- 1
- Number Of Participants
- 20
Sites
- Site Name
- Haukeland University Hospital
- Department Name
- Cardiology and intensive care
- Contact Person Name
- Gard Svingen
- Contact Person Email
- gard.frodahl.tveitevag.svingen@helse-bergen.no
Sweden
- Earliest CTIS Part Ii Submission Date
- 29-07-2024
- Latest Decision Or Authorization Date
- 08-10-2025
- Processing Time Days
- 436
- Number Of Sites
- 1
- Number Of Participants
- 25
Sites
- Site Name
- Lund University Hospital
- Department Name
- Cardiology
- Contact Person Name
- Arash Mokhtari
- Contact Person Email
- arashm83@gmail.com
Denmark
- Earliest CTIS Part Ii Submission Date
- 30-01-2024
- Latest Decision Or Authorization Date
- 09-10-2025
- Processing Time Days
- 617
- Number Of Sites
- 1
- Number Of Participants
- 75
Sites
- Site Name
- Rigshospitalet
- Department Name
- Intensive care
- Contact Person Name
- Christian Hassager
- Contact Person Email
- hassager@dadlnet.dk
Belgium
- Earliest CTIS Part Ii Submission Date
- 12-03-2025
- Latest Decision Or Authorization Date
- 18-02-2026
- Processing Time Days
- 343
- Number Of Sites
- 4
- Number Of Participants
- 45
Sites
- Site Name
- CHU Charleroi
- Department Name
- Intensive care
- Contact Person Name
- David Fagnoul
- Contact Person Email
- patrick.biston@humani.be
- Site Name
- University Hospitals Leuven
- Department Name
- Cardiology and intensive care
- Contact Person Name
- Pascal Frederiks
- Contact Person Email
- pascal.frederiks@uzleuven.be
- Site Name
- UZ Brussel
- Department Name
- Cardiology and intensive care
- Contact Person Name
- Tim Balthazar
- Contact Person Email
- tim.balthazar@uzbrussel.be
- Site Name
- CHC MontLegia
- Department Name
- Interventional cardiology and intensive care
- Contact Person Name
- Pieter-Jan Palmers
- Contact Person Email
- pieter-jan.palmers@chc.be
Sponsor
Primary sponsor
- Full Name
- Amsterdam UMC
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Netherlands
Investigational products
- Investigational Product Name
- NOREPINEPHRINE
- Active Substance
- NORADRENALINE TARTRATE
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS INFUSION
- Route
- Intravenous infusion
- Authorisation Status
- Authorised (used in accordance with the marketing authorisation)
- Dose Levels
- Max daily dose 18 mg; max total dose 200 mg
- Maximum Dose
- 18 mg per day (max); 200 mg total (max)
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