Clinical trial • Phase III • Cardiology
METHYLPREDNISOLONE SODIUM SUCCINATE for Acute myocarditis | Severe cardiac inflammation
Phase III trial of METHYLPREDNISOLONE SODIUM SUCCINATE for Acute myocarditis | Severe cardiac inflammation.
Overview
- Trial Therapeutic Area
- Cardiology
- Trial Disease
- Acute myocarditis | Severe cardiac inflammation
- Trial Stage
- Phase III
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 10-06-2024
- First CTIS Authorization Date
- 16-07-2024
Trial design
Randomised, placebo comparator: sodio cloruro fresenius kabi italia 0,9% solution for infusion (sodium chloride) administered by intravenous infusion (placebo). test intervention: solu medrol 1000 mg/15.6 ml (methylprednisolone sodium succinate) intravenous administration; product info lists max daily dose 1000 mg and max total dose 3000 mg over a maximum treatment period of 3 days.-controlled Phase III trial in Austria, Slovenia, Italy and others.
- Randomised
- Yes
- Comparator
- Placebo comparator: Sodio cloruro Fresenius Kabi Italia 0,9% solution for infusion (sodium chloride) administered by intravenous infusion (placebo). Test intervention: SOLU MEDROL 1000 mg/15.6 ml (methylprednisolone sodium succinate) intravenous administration; product info lists max daily dose 1000 mg and max total dose 3000 mg over a maximum treatment period of 3 days.
- Target Sample Size
- 120
- Trial Duration For Participant
- 182
Eligibility
Recruits 120 Vulnerable population not selected (isVulnerablePopulationSelected=false). Trial enrols adults aged 18-69. Subject information and consent forms include specific versions for incapacitated subjects (e.g. "L1_SIS and ICF_INCAPACITATED subjects_Austria") and documents indicating provisions for deferred/delayed consent (e.g. Finland informed consent variants), and country-specific ICFs are provided..
- Pregnancy Exclusion
- Pregnant women (known pregnancy) or POSITIVE human chorionic gonadotropin (HCG) test measures (urine/blood) for women of 18-50 years of age.
- Vulnerable Population
- Vulnerable population not selected (isVulnerablePopulationSelected=false). Trial enrols adults aged 18-69. Subject information and consent forms include specific versions for incapacitated subjects (e.g. "L1_SIS and ICF_INCAPACITATED subjects_Austria") and documents indicating provisions for deferred/delayed consent (e.g. Finland informed consent variants), and country-specific ICFs are provided.
Inclusion criteria
- {"criterion_text":"- Age 18 years or older and below 70 years (18-69 years)\n- Acute HF with clinically suspected acute myocarditis based on an N-terminal pro–B-type natriuretic peptide (NT-proBNP) concentration of 1600 pg/mL or more or a B-type natriuretic peptide (BNP) concentration of 400 pg/mL or more;\n- Left ventricular ejection fraction (LVEF)<41% and left ventricular end diastolic diameter (LV-EDD)<56 mm (parasternal long-axis view) on echocardiogram.\n- Increased troponin (3x upper reference limit [URL]) at the time of randomization.\n- Clinical onset of cardiac symptoms within 3 weeks from randomization.\n- Excluded coronary artery disease by coronary angiogram in subjects ≥46 years of age, in case myocarditis is not histologically proven.\n- Randomization within 120 hours from hospital admission."}
Exclusion criteria
- {"criterion_text":"- Known systemic autoimmune disorder or other conditions at the time of randomization where immunosuppression is assumed useful. Patients in whom a systemic autoimmune disorder will be diagnosed during hospitalization will be included in the study if randomized, including patients with a diagnosis of cardiac sarcoidosis or GCM). Both patients included in the corticosteroids-treatment arm or in the placebo-treatment arm can receive the standard immunosuppressive therapy used in the center since the diagnosis.\n- t-MCS instituted more than 72 hours before randomization.\n- Patients clinically judged too sick to initiate t-MCS (i.e., irreversible multiorgan failure).\n- Echocardiographic presence of images suggestive of other cardiac diseases (i.e. endocarditis).\n- Participants involved in another clinical trial.\n- Pregnant women (known pregnancy) or POSITIVE human chorionic gonadotropin (HCG) test measures (urine/blood) for women of 18-50 years of age.\n- Any other significant disease with expected life expectancy <12 months (i.e., evidence of irreversible severe brain injury) or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant’s ability to participate in the trial.\n- Patients already on oral/IV chronic corticosteroid therapy or other chronic immunosuppressive therapies (colchicine or nonsteroidal anti-inflammatory drugs [NSAIDs] are not considered immunosuppressive drugs)\n- Contraindication to corticosteroids, including allergies to this medication and its excipients.\n- Patients with persistent peripheral eosinophilia (persistent eosinophil count >7% of the leukocytes) or known hypereosinophilic syndrome at the time of randomization. Patients in whom eosinophilic myocarditis will be diagnosed on EMB will be included in the study if already randomized. Both patients included in the corticosteroids-treatment arm or in the placebo-treatment arm can receive the standard immunosuppressive therapy used in the center since the diagnosis.\n- Myocarditis associated with the ongoing administration of anti-cancer immune checkpoint inhibitor (ICI) agents.\n- Previously known chronic cardiac disease (i.e., previous cardiomyopathy, that does NOT include previous myocarditis if there is a functional recovery at the time of screening).\n- Evidence of active bacterial or fungal infectious disease (presence of fever or increased C-reactive protein are not considered exclusion criteria), or suspected bacterial/fungal infection associated with increased levels of procalcitonin (cut-off >10 ng/mL), if the laboratory exam is available in the center.\n- Known chronic infective disease, such as HIV infection or tuberculosis.\n- Out-of-hospital cardiac arrest."}
Endpoints
Primary endpoints
- {"endpoint_text":"- The Primary composite endpoint is defined as the time from randomization to the first event occurring within 6 months among: (1) all-cause death, or (2) HTx, or (3) long-term LVAD implant, or (4) need for an upgrading of the t-MCS, or (5) a ventricular tachycardia (VT)/fibrillation (VF) treated with direct current (DC) shock (excluding VT/VF in patients on t-MCS other than IABP), or (6) first rehospitalization due to HF or ventricular arrhythmias, or advanced AV block.","definition_or_measurement_approach":"Time-to-event (time from randomization) measured up to 6 months; composite of listed clinical events (all-cause death, heart transplant (HTx), long-term LVAD implant, need for upgrading t-MCS, VT/VF treated with DC shock [with specified exclusions], first rehospitalization for HF or ventricular arrhythmias, or advanced AV block)."}
Secondary endpoints
- {"endpoint_text":"- The time from randomization to the first event occurring within 6 months among: (1) all-cause death or (2) HTx or (3) long-term LVAD implant or (4) first rehospitalization due to HF or ventricular arrhythmias, or advanced AV block.","definition_or_measurement_approach":"Time-to-event within 6 months for the listed composite events."}
- {"endpoint_text":"- Mortality: time from randomization to all-cause death within 6 months.","definition_or_measurement_approach":"Time-to-event (all-cause death) within 6 months."}
- {"endpoint_text":"- In-hospital composite endpoint is defined as the proportion of patients who experience at least one of the following events during index hospitalization: (1) all-cause death, or (2) HTx, or (3) long-term LVAD implant, or (4) need for an upgrading of the t-MCS, or (5) a VT/VF treated with DC shock (excluding VT/VF in patients on t-MCS other than IABP).","definition_or_measurement_approach":"Proportion of patients experiencing any listed event during index hospitalization."}
- {"endpoint_text":"- Number of days on t-MCS from randomization.","definition_or_measurement_approach":"Count of days requiring temporary mechanical circulatory support (t-MCS) from randomization."}
- {"endpoint_text":"- Number of days in ICU from randomization.","definition_or_measurement_approach":"Count of ICU days from randomization."}
- {"endpoint_text":"- Increase in LVEF on echocardiogram after 5 days from randomization (ECHO clips will be centrally reviewed in a blind fashion by readers).","definition_or_measurement_approach":"Change in LVEF measured by echocardiogram at day 5 post-randomization; central blinded review of ECHO clips."}
- {"endpoint_text":"- Relative reduction of troponin levels after 5 days from randomization (ratio of troponin level/local troponin URL).","definition_or_measurement_approach":"Ratio of troponin level to local upper reference limit measured at day 5; relative reduction from baseline."}
- {"endpoint_text":"- Reduction in heart rate (HR) on ECG after 3 days from randomization (ECG recorded at the hour of initial randomization - ECGs will be centrally reviewed in a blind fashion by readers).","definition_or_measurement_approach":"Change in heart rate on ECG at day 3 vs baseline ECG recorded at randomization; central blinded ECG review."}
- {"endpoint_text":"- Proportion of patients with LVEF<55% AND/OR LV dilation on 6-month cardiac magnetic resonance imaging (CMRI) (CMRI clips will be centrally reviewed in a blind fashion by readers).","definition_or_measurement_approach":"Proportion with LVEF<55% and/or LV dilation on 6-month CMRI; central blinded CMRI review."}
- {"endpoint_text":"- Proportion of patients with LVEF<55% on 6-month CMRI (CMRI clips will be centrally reviewed in a blind fashion by readers).","definition_or_measurement_approach":"Proportion with LVEF<55% at 6-month CMRI; central blinded CMRI review."}
- {"endpoint_text":"- Proportion of patients with LV dilation on 6-month CMRI (CMRI clips will be centrally reviewed in a blind fashion by readers).","definition_or_measurement_approach":"Proportion with LV dilation at 6-month CMRI; central blinded CMRI review."}
Recruitment
- Planned Sample Size
- 120
- Recruitment Window Months
- 54
- Consent Approach
- Informed consent obtained from adult participants (trial population 18-69 years). Country-specific subject information and informed consent forms are provided (documents available for Italy, Austria, Slovenia, Spain, Belgium, Finland, Czechia). There are dedicated ICF versions for incapacitated subjects and contact lists; Finland materials include deferred/delayed consent variants, indicating procedures for participants lacking capacity or delayed consent where applicable.
Geography
- Total Number Of Sites
- 43
- Total Number Of Participants
- 120
Austria
- Earliest CTIS Part Ii Submission Date
- 17-02-2025
- Latest Decision Or Authorization Date
- 28-02-2025
- Processing Time Days
- 11
- Number Of Sites
- 3
- Number Of Participants
- 20
Sites
- Site Name
- Medical University Of Vienna
- Department Name
- Cardiology
- Principal Investigator Name
- Max Lenz
- Principal Investigator Email
- max.lenz@meduniwien.ac.at
- Contact Person Name
- Max Lenz
- Contact Person Email
- max.lenz@meduniwien.ac.at
- Site Name
- Medical University Of Innsbruck
- Department Name
- Cardiology and Angiology
- Principal Investigator Name
- Gerhard Poelzl
- Principal Investigator Email
- Gerhard.poelzl@tirol-kliniken.at
- Contact Person Name
- Gerhard Poelzl
- Contact Person Email
- Gerhard.poelzl@tirol-kliniken.at
- Site Name
- Medical University of Graz
- Department Name
- Cardiology
- Principal Investigator Name
- Markus Wallner
- Principal Investigator Email
- markus.wallner@medunigraz.at
- Contact Person Name
- Markus Wallner
- Contact Person Email
- markus.wallner@medunigraz.at
Slovenia
- Earliest CTIS Part Ii Submission Date
- 30-10-2024
- Latest Decision Or Authorization Date
- 07-02-2025
- Processing Time Days
- 100
- Number Of Sites
- 1
- Number Of Participants
- 15
Sites
- Site Name
- Univerzitetni klinicni center Ljubljana
- Department Name
- Cardiology
- Principal Investigator Name
- Andreja Cerne
- Principal Investigator Email
- andreja.cerne@kclj.si
- Contact Person Name
- Andreja Cerne
- Contact Person Email
- andreja.cerne@kclj.si
Italy
- Earliest CTIS Part Ii Submission Date
- 03-06-2024
- Latest Decision Or Authorization Date
- 22-07-2024
- Processing Time Days
- 49
- Number Of Sites
- 22
- Number Of Participants
- 19
Sites
- Site Name
- Università degli Studi di Firenze-Azienda Ospedaliero Universitaria Careggi SC di Oncologia Medical
- Department Name
- Cardiologia
- Principal Investigator Name
- Francesco Cappelli
- Principal Investigator Email
- f.cappelli@unifi.it
- Contact Person Name
- Francesco Cappelli
- Contact Person Email
- f.cappelli@unifi.it
- Site Name
- Azienda Ospedaliera Specialistica dei Colli – Ospedale Monaldi
- Department Name
- UOC Cardiologia
- Principal Investigator Name
- Francesco Loffredo
- Principal Investigator Email
- francesco.loffredo@unicampania.it
- Contact Person Name
- Francesco Loffredo
- Contact Person Email
- francesco.loffredo@unicampania.it
- Site Name
- Azienda di Rilievo Nazionale ed Alta Specializzazione - ARNAS “G. Brotzu” (Ente)
- Department Name
- Cardiologia
- Principal Investigator Name
- Marco Corda
- Principal Investigator Email
- marcocorda2@aob.it
- Contact Person Name
- Marco Corda
- Contact Person Email
- marcocorda2@aob.it
- Site Name
- Azienda Ospedaliero Universitaria di Parma
- Department Name
- Dipartimento Cardio-Toraco-Vascolare
- Principal Investigator Name
- Diego Ardissino
- Principal Investigator Email
- dardissino@ao.pr.it
- Contact Person Name
- Diego Ardissino
- Contact Person Email
- dardissino@ao.pr.it
- Site Name
- U.O.C. Cardiologia, Azienda Ospedaliera San Camillo-Forlanini
- Department Name
- UOC Cardiologia
- Principal Investigator Name
- Leonardo De Luca
- Principal Investigator Email
- leo.deluca@libero.it
- Contact Person Name
- Leonardo De Luca
- Contact Person Email
- leo.deluca@libero.it
- Site Name
- Fondazione IRCCS Policlinico San Matteo
- Department Name
- UOC Unità Intensiva Cardiologica
- Principal Investigator Name
- Rita Camporotondo
- Principal Investigator Email
- r.camporotondo@smatteo.pv.it
- Contact Person Name
- Rita Camporotondo
- Contact Person Email
- r.camporotondo@smatteo.pv.it
- Site Name
- Fondazione Gabriele Monasterio, San Cataldo Hospital, CNR Research Area
- Department Name
- Cardiologia
- Principal Investigator Name
- Michele Emdin
- Principal Investigator Email
- m.emdin@santannapisa.it
- Contact Person Name
- Michele Emdin
- Contact Person Email
- m.emdin@santannapisa.it
- Site Name
- Azienda Ospedaliera Universitaria Senese
- Department Name
- Cardiologia
- Principal Investigator Name
- Serafina Valente
- Principal Investigator Email
- seravalente@gmail.com
- Contact Person Name
- Serafina Valente
- Contact Person Email
- seravalente@gmail.com
- Site Name
- Azienda Ospedaliera Universitaria Città della Salute e della Scienza di Torino
- Department Name
- Cardiologia
- Principal Investigator Name
- Gaetano Maria De Ferrari
- Principal Investigator Email
- gaetanomaria.deferrari@unito.it
- Contact Person Name
- Gaetano Maria De Ferrari
- Contact Person Email
- gaetanomaria.deferrari@unito.it
- Site Name
- AOU Ospedali Riuniti Umberto I°-Lancisi-Salesi di Ancona
- Department Name
- Cardiologia
- Principal Investigator Name
- Marco Marini
- Principal Investigator Email
- marcomarini1975@gmail.com
- Contact Person Name
- Marco Marini
- Contact Person Email
- marcomarini1975@gmail.com
- Site Name
- Presidio Ospedaliero Universitario "Santa Maria della Misericordia"
- Department Name
- Cardiologia
- Principal Investigator Name
- Massimo Imazio
- Principal Investigator Email
- massimo.imazio@uniud.it
- Contact Person Name
- Massimo Imazio
- Contact Person Email
- massimo.imazio@uniud.it
- Site Name
- Fondazione IRCCS San Gerardo Dei Tintori
- Department Name
- Cardiologia
- Principal Investigator Name
- Davide Corsi
- Principal Investigator Email
- davidecorsi.hsg@gmail.com
- Contact Person Name
- Davide Corsi
- Contact Person Email
- davidecorsi.hsg@gmail.com
- Site Name
- ASST Spedali Civili di Brescia
- Department Name
- UOC Cardiologia
- Principal Investigator Name
- Daniela Tomasoni
- Principal Investigator Email
- danielatomasoni8@gmail.com
- Contact Person Name
- Daniela Tomasoni
- Contact Person Email
- danielatomasoni8@gmail.com
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- UO Cardiologia
- Principal Investigator Name
- Maria Lucia Narducci
- Principal Investigator Email
- marialucia.narducci@policlinicogemelli.it
- Contact Person Name
- Maria Lucia Narducci
- Contact Person Email
- marialucia.narducci@policlinicogemelli.it
- Site Name
- Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
- Department Name
- Dipartimento cardiovascolare
- Principal Investigator Name
- Aurelia Grosu
- Principal Investigator Email
- agrosu@asst-pg23.it
- Contact Person Name
- Aurelia Grosu
- Contact Person Email
- agrosu@asst-pg23.it
- Site Name
- Ospedale Ss Annunziata
- Department Name
- Cardiology
- Principal Investigator Name
- Marco Zimarino
- Principal Investigator Email
- m.zimarino@unich.it
- Contact Person Name
- Marco Zimarino
- Contact Person Email
- m.zimarino@unich.it
- Site Name
- Azienda Ospedaliera Specialistica dei Colli – Ospedale Monaldi
- Department Name
- Cardiologia
- Principal Investigator Name
- Francesco Loffredo
- Principal Investigator Email
- francesco.loffredo@unicampania.it
- Contact Person Name
- Francesco Loffredo
- Contact Person Email
- francesco.loffredo@unicampania.it
- Site Name
- Policlinico S.Orsola-Malpighi
- Department Name
- UO Cardiologia
- Principal Investigator Name
- Luciano Potena
- Principal Investigator Email
- luciano.potena2@unibo.it
- Contact Person Name
- Luciano Potena
- Contact Person Email
- luciano.potena2@unibo.it
- Site Name
- IRCCS Ospedale Policlinico San Martino
- Department Name
- Cardiologia
- Principal Investigator Name
- Roberta Della Bona
- Principal Investigator Email
- roberta.dellabona@gmail.com
- Contact Person Name
- Roberta Della Bona
- Contact Person Email
- roberta.dellabona@gmail.com
- Site Name
- ASST Grande Ospedale Metropolitano Niguarda
- Department Name
- De Gasperis Cardio Center and Transplant Center
- Principal Investigator Name
- Enrico Ammirati
- Principal Investigator Email
- enrico.ammirati@ospedaleniguarda.it
- Contact Person Name
- Enrico Ammirati
- Contact Person Email
- enrico.ammirati@ospedaleniguarda.it
- Site Name
- Centro Cardiologico Monzino S.p.A.
- Department Name
- Cardiologia
- Principal Investigator Name
- Jeness Campodonico
- Principal Investigator Email
- jeness.campodonico@cardiologicomonzino.it
- Contact Person Name
- Jeness Campodonico
- Contact Person Email
- jeness.campodonico@cardiologicomonzino.it
- Site Name
- Alessandro Manzoni Hospital
- Department Name
- Cardiology
- Principal Investigator Name
- Roberto Spoladore
- Principal Investigator Email
- r.spoladore@asst-lecco.it
- Contact Person Name
- Roberto Spoladore
- Contact Person Email
- r.spoladore@asst-lecco.it
Spain
- Earliest CTIS Part Ii Submission Date
- 03-06-2024
- Latest Decision Or Authorization Date
- 20-07-2024
- Processing Time Days
- 47
- Number Of Sites
- 9
- Number Of Participants
- 18
Sites
- Site Name
- HOSPITALDE LA SANT CREU I SANT PAU
- Department Name
- Cardiology
- Principal Investigator Name
- Alessandro Sionis
- Principal Investigator Email
- asionis@santpau.cat
- Contact Person Name
- Alessandro Sionis
- Contact Person Email
- asionis@santpau.cat
- Site Name
- Hospital Universitario Vall d'Hebron
- Department Name
- Cardiologia
- Principal Investigator Name
- aitor Uribarri
- Principal Investigator Email
- auribarrig@gmail.com
- Contact Person Name
- aitor Uribarri
- Contact Person Email
- auribarrig@gmail.com
- Site Name
- Hospital Universitario Virgen de la Arrixaca
- Department Name
- Cardiologia
- Principal Investigator Name
- Domingo Pascual
- Principal Investigator Email
- dpascual@um.es
- Contact Person Name
- Domingo Pascual
- Contact Person Email
- dpascual@um.es
- Site Name
- Complexo Hospitalario Universitario A Coruña (CHUAC), A Coruña
- Department Name
- Cardiologia
- Principal Investigator Name
- Maria G. Crespo Leiro
- Principal Investigator Email
- marisacrespo@gmail.com
- Contact Person Name
- Maria G. Crespo Leiro
- Contact Person Email
- marisacrespo@gmail.com
- Site Name
- Bellvitge University Hospital
- Department Name
- Cardiologia
- Principal Investigator Name
- albert ariza sole
- Principal Investigator Email
- aariza@bellvitgehospital.cat
- Contact Person Name
- albert ariza sole
- Contact Person Email
- aariza@bellvitgehospital.cat
- Site Name
- Hospital General Universitario Gregorio Maranon
- Department Name
- Cardiologia
- Principal Investigator Name
- Manuel Martinez Selles
- Principal Investigator Email
- mmselles@secardiologia.es
- Contact Person Name
- Manuel Martinez Selles
- Contact Person Email
- mmselles@secardiologia.es
- Site Name
- Hospital 12 de Octubre
- Department Name
- Cardiologia
- Principal Investigator Name
- Vanesa Bruña
- Principal Investigator Email
- vanesa.bruna@salud.madrid.org
- Contact Person Name
- Vanesa Bruña
- Contact Person Email
- vanesa.bruna@salud.madrid.org
- Site Name
- Hospital Universitario Puerta de Hierro
- Department Name
- Cardiologia
- Principal Investigator Name
- fernando Dominguez
- Principal Investigator Email
- fdominguezrodriguez@gmail.com
- Contact Person Name
- fernando Dominguez
- Contact Person Email
- fdominguezrodriguez@gmail.com
- Site Name
- Hospital Universitario Virgen De La Victoria
- Department Name
- Cardiologia
- Principal Investigator Name
- Jose Manuel Garcia
- Principal Investigator Email
- pinilla@secardiologia.es
- Contact Person Name
- Jose Manuel Garcia
- Contact Person Email
- pinilla@secardiologia.es
Belgium
- Earliest CTIS Part Ii Submission Date
- 03-06-2024
- Latest Decision Or Authorization Date
- 16-07-2024
- Processing Time Days
- 43
- Number Of Sites
- 4
- Number Of Participants
- 3
Sites
- Site Name
- Antwerp University Hospital
- Department Name
- Cardiology
- Principal Investigator Name
- Caroline Van De Heyning
- Principal Investigator Email
- carolinevandeheyning@uza.be
- Contact Person Name
- Caroline Van De Heyning
- Contact Person Email
- carolinevandeheyning@uza.be
- Site Name
- University Hospitals Leuven
- Department Name
- Cardiology
- Principal Investigator Name
- Cristophe vandenbriele
- Principal Investigator Email
- christophe.vandenbriele@kuleuven.be
- Contact Person Name
- Cristophe vandenbriele
- Contact Person Email
- christophe.vandenbriele@kuleuven.be
- Site Name
- Jessa Hospital
- Department Name
- Cardiology
- Principal Investigator Name
- Philippe Jr. Timmermans
- Principal Investigator Email
- philippe.jr.timmermans@jessazh.be
- Contact Person Name
- Philippe Jr. Timmermans
- Contact Person Email
- philippe.jr.timmermans@jessazh.be
- Site Name
- Onze Lieve Vrouwziekenhuis
- Department Name
- Cardiology
- Principal Investigator Name
- Ward Heggermont
- Principal Investigator Email
- ward.heggermont@olvz-aalst.be
- Contact Person Name
- Ward Heggermont
- Contact Person Email
- ward.heggermont@olvz-aalst.be
Czechia
- Earliest CTIS Part Ii Submission Date
- 05-02-2025
- Latest Decision Or Authorization Date
- 26-02-2025
- Processing Time Days
- 21
- Number Of Sites
- 3
- Number Of Participants
- 30
Sites
- Site Name
- Masaryk University St. Anne's University Hospital Brno- Czechia
- Department Name
- Cardiology
- Principal Investigator Name
- Jan Krejci
- Principal Investigator Email
- jan.krejci@fnusa.cz
- Contact Person Name
- Jan Krejci
- Contact Person Email
- jan.krejci@fnusa.cz
- Site Name
- Charles University in prague and General University Hospital
- Department Name
- Cardiology
- Principal Investigator Name
- Petr Kuchynka
- Principal Investigator Email
- Petr.Kuchynka@vfn.cz
- Contact Person Name
- Petr Kuchynka
- Contact Person Email
- Petr.Kuchynka@vfn.cz
- Site Name
- Institute for Clinical and Experimental Medicine
- Department Name
- Cardiology
- Principal Investigator Name
- Vojtech Melenovsky
- Principal Investigator Email
- vome@ikem.cz
- Contact Person Name
- Vojtech Melenovsky
- Contact Person Email
- vome@ikem.cz
Finland
- Earliest CTIS Part Ii Submission Date
- 28-01-2025
- Latest Decision Or Authorization Date
- 24-02-2025
- Processing Time Days
- 27
- Number Of Sites
- 1
- Number Of Participants
- 15
Sites
- Site Name
- Heart and Lung Center, Helsinki University Hospital
- Department Name
- Cardiology
- Principal Investigator Name
- Jukka Lehtonen
- Principal Investigator Email
- Jukka.Lehtonen@hus.fi
- Contact Person Name
- Jukka Lehtonen
- Contact Person Email
- Jukka.Lehtonen@hus.fi
Sponsor
Primary sponsor
- Full Name
- ASST Grande Ospedale Metropolitano Niguarda
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Italy
Third parties
- {"country":"Italy","full_name":"Ministry of Health, Italy","duties_or_roles":"Monetary support","organisation_type":""}
- {"country":"Italy","full_name":"PFIZER ITALIA S.R.L.","duties_or_roles":"Marketing authorisation holder for SOLU MEDROL (product listed in trial)","organisation_type":""}
- {"country":"Italy","full_name":"FRESENIUS KABI ITALIA S.R.L.","duties_or_roles":"Marketing authorisation holder for sodium chloride product used as placebo","organisation_type":""}
Investigational products
- Investigational Product Name
- SOLU MEDROL 1000 mg/15,6 ml polvere e solvente per soluzione iniettabile
- Active Substance
- METHYLPREDNISOLONE SODIUM SUCCINATE
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS USE
- Route
- Intravenous
- Authorisation Status
- Authorised in Italy (marketing authorisation present: marketingAuthNumber 023202068)
- Starting Dose
- 1000 mg
- Maximum Dose
- 3000 mg (max total amount)
- Investigational Product Name
- Sodio cloruro Fresenius Kabi Italia 0,9%, soluzione per infusione
- Active Substance
- SODIUM CHLORIDE
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS INFUSION
- Route
- Intravenous infusion
- Authorisation Status
- Authorised in Italy (marketing authorisation present: marketingAuthNumber 031938463)
- Starting Dose
- Up to 250 ml per day
- Maximum Dose
- 750 ml (max total amount)
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