Project Details
Projekt
The design and conduct of clinical trials for the use of anticoagulation and antiplatelet regimes in patients with atrial fibrillation
Applicant
Dr. Diona Gjermeni
Subject Area
Cardiology, Angiology
Term
since 2024
Project identifier
Deutsche Forschungsgemeinschaft (DFG) - Project number 541759009
Dr. Diona Gjermeni is applying for the Benjamin Walter Programme for a 24-month exchange in the Stanford Center for Clinical Research in Stanford (SCCR), USA. The applicant has been focused on clinical research regarding anticoagulation and antiplatelet therapy in cardiac patients and has successfully closed 3 prospective cohort studies since 2020. The first objective of this project is for the applicant to increase knowledge on the design and conduct of clinical trials. Thus, the primary objective of this project is to design and conduct a prospective clinical trial to be able to detect patients at higher risk for ischemic and bleeding complications through platelet function testing with multiple electrode aggregometry in a big cohort of 1000 patients with atrial fibrillation undergoing stent implantation. The value of platelet function testing to help us guide the antithrombotic therapy regimen after stent implantation in this patient cohort is still not completely established. The ultimate aim of this study is to help us perform more patient-oriented decisions regarding antithrombotic therapy regimens after stent implantation. Furthermore, the applicant will work with trials in the ongoing phase and trials in the final stage. Ongoing randomized controlled trials where the applicant is going to participate are REACT-AF and LIBREXIA Factor XI, both trials regarding patients with atrial fibrillation, anticoagulation therapy regimens, and digital health. The applicant will integrate with the clinical coordinating center operations team at the Stanford Center for Clinical Research and will be involved in patient recruitment, site management, event adjudication, and safety monitoring. The applicant will have access to big databases regarding important randomized controlled trials that have been closed up such as: Apple Heart Study, REFLECS Study, ENAHNCE-AF Trial, and CANVAS Trial. Numerous secondary analyses are planned to take place mostly regarding the identification of subgroups at risk for complications in order to detect groups that are eligible for individualized therapy. The main aim is to improve the knowledge on statistics and epidemiology in clinical trials. During the exchange, the applicant will be supervised by Prof. Dr. Mahaffey who is an expert in the design and conduct of clinical trials and is currently the Vice Chair of Medicine for Clinical Research at the Department of Medicine and the Director of the SCCR. The ultimate aim is to transfer this knowledge to Germany in order to independently be able to design and conduct randomized controlled trials as well as to improve the knowledge of the structure of a clinical research center and build a network for possible future international collaborations.
DFG Programme
WBP Fellowship
International Connection
USA
