Rohr, Brit S.
Krohmer, Evelyn http://orcid.org/0009-0004-8636-7993
Foerster, Kathrin I. http://orcid.org/0000-0001-8583-7181
Burhenne, Jürgen http://orcid.org/0000-0002-2190-1698
Schulz, Martin http://orcid.org/0000-0002-5876-7322
Blank, Antje http://orcid.org/0000-0001-8743-5194
Mikus, Gerd http://orcid.org/0000-0003-1783-133X
Haefeli, Walter E. http://orcid.org/0000-0003-0672-6876
Funding for this research was provided by:
Medizinischen Fakultät Heidelberg, Universität Heidelberg
Universitätsklinikum Heidelberg
Article History
Accepted: 29 January 2024
First Online: 23 February 2024
Declarations
:
: Open Access funding enabled and organized by Projekt DEAL. This trial was funded by the Department’s internal resources. No medical writing support was used.
: Walter E. Haefeli received grants for clinical trials, travel support, and lecture fees from Daiichi Sankyo, the manufacturer of edoxaban, not related to this work. All other authors have no conflicts of interest to declare.
: The collected and analysed data can be made available upon reasonable request. Part of the data was presented at the 19th World Congress of Clinical Pharmacology, Glasgow, and therefore published as an abstract [].
: The trial protocol (EudraCT 2021-006634-39) was approved by the competent authority (BfArM, Bonn, Germany) and the responsible Ethics Committee of the Medical Faculty of Heidelberg University. All procedures performed in studies involving human participants were in accordance with Good Clinical Practice (ICH-GCP) guidelines, all pertinent German laws, and the ethical standards specified in the applicable version of the declaration of Helsinki. All volunteers gave their written informed consent prior to any study procedures.
: The trial was registered at the European Union Drug Regulating Authorities for Clinical Trials (EudraCT-No. 2021-006643-39) and at German Clinical Trial Register with ID DRKS00027838.
: WEH and GM proposed the research topic. BSR, AB, EK, WEH, and GM developed the trial protocol. BSR was the responsible study physician and executed the trial. KIF and JB analysed the samples. BSR and GM performed the trial analysis and the statistics. BSR wrote the first draft of the manuscript. All authors discussed and interpreted the results and contributed to the manuscript.