Title {1} |
Interleukin-6 Receptor Antibodies (tocilizumab) in Acute Myocardial Infarction with Intermediate to High Risk of Cardiogenic Shock Devel-opment (DOBERMANN-T): Study protocol for a double-blinded, placebo-controlled, single-center, randomized clinical trial |
Trial registration {2a and 2b}. |
Regional Ethics Committee: H-21045751. EudraCT: 2021–002028-19. ClinicalTrials.gov: NCT05350592. WHO Universal Trial Number: U1111-1277–8523 |
Protocol version {3} |
Issue date: August 01, 2022. Protocol amendment number: 04. |
Funding {4} |
External financial grants: Novo Nordisk Foundation. Simon Spies Foundation. Helge Peetz og Verner Peetz og hustru Vilma Peetz Legat. Internal financial grants: Rigshospitalets Apparaturudvalg Rigshospitalets The Heart Centre Research Committee |
Author details {5a} |
Joakim Bo Kunkel, MD Department of Cardiology The Heart Centre Copenhagen University Hospital—Rigshospitalet Ryesgade 53, 9841, DK-2100 Copenhagen, Denmark E-mail: joakim.bo.kunkel@regionh.dk Phone: + 45 60 60 39 10 |
Name and contact information for the trial sponsor {5b} |
Christian Hassager, MD, DMSc Department of Cardiology The Heart Centre Copenhagen University Hospital—Rigshospitalet Inge Lehmanns Vej 7, DK-2100 Copenhagen, Denmark E-mail: christian.hassager@regionh.dk. Phone: + 45 35 45 05 72 |
Role of sponsor {5c} | The Sponsor has status as Sponsor-Investigator and is thus directly involved with the initiation, design, and execution of the trial. |