The design and conduct of clinical trials for antithrombotic regimes in cardiac patients

• Applicant: Privatdozent Dr. Christoph Olivier
• Subject Area: Cardiology, Angiology ; Epidemiology and Medical Biometry/Statistics
• Term: from 2015 to 2019
• Project identifier: Deutsche Forschungsgemeinschaft (DFG) - Project number 279700047

Germany suffers a need for knowledge of the design and conduct in clinical trials. Therefore, the DFG began the program ´Nachwuchsakademie Klinische Studien´. Recently, the applicant successfully completed a grant of the DFG within this program and now focuses his scientific work on clinical trials in cardiac patients. Modern drugs offer new antithrombotic regimes for cardiac patients and it is still a challenge to find the optimal balance of reducing thromboembolic complications without running an excessive bleeding risk in those patients. The first objective of this project is to acquire knowledge of the design and conduct in clinical trials and import this knowledge to Germany. The second objective is to improve antithrombotic therapy and clinical outcome in cardiac patients. The project will take place at the Stanford Center for Clinical Research of Stanford University (USA) under the mentoring of Prof. Harrington and Prof. Mahaffey, experts in the field of clinical investigation. In order to guarantee a full spectrum of methodological training the applicant will be involved in all stages of clinical trials: the conceptual, the ongoing and the final stage. The main focus lies in the design and realization of a randomized controlled trial (RCT). This trial aims to improve clinical outcome of patients after percutaneous coronary intervention (PCI) with high platelet reactivity (HPR) defined by a high ratio of ADP-TRAP induced platelet aggregation. Patients will be randomized to either stay with their antiplatelet therapy or switch to third generation P2Y12 antagonists. As a second project the applicant plans to design and conduct a platelet function substudy of a RCT in patients with atrial fibrillation after PCI. The applicant aims to identify patients with HPR and compare different antithrombotic strategies. By working with the faculty leadership and operational teams running an ongoing large clinical outcome study, the applicant will improve his experience and form international collaborations. The applicant will be involved with the creation of timelines and milestones to complete an ongoing clinical trial and perform secondary analyzes of data from a completed large outcome trial to understand the clinical trial results and integration of findings in clinical practice. Secondarily, the applicant will learn the structures of a clinical research center and develop global investigative networks for future collaboration. The acquired knowledge and the investigative network will enable the applicant to establish a clinical research center in Germany. The results of the first project will demonstrate if switching antiplatelet therapy in selected patients can improve clinical outcome after PCI. In a second project the best antithrombotic regime for patients with atrial fibrillation after PCI will be identified. Further secondary analyzes will help to resolve important clinical cardiac issues of antithrombotic therapy.

• DFG Programme: Research Fellowships
• International Connection: USA
• Host: Professor Dr. Kenneth W. Mahaffey