Characterising the risk of major bleeding in patients with Non-Valvular Atrial Fibrillation

For more information on this project, please contact the EU PE&PV Research Network at eupepv@uu.nl.

Project information

  • EU PE&PV research network
  • Specific Contract 01 implementing Framework service contract EMA/2015/27/PH

Full title

Characterising the risk of major bleeding in patients with Non-Valvular Atrial Fibrillation: non-interventional study of patients taking Direct Oral Anticoagulants in the EU

Principal investigator

Prof. Dr. Helga Gardarsdottir, Utrecht 木瓜福利影视

Participating organisations

  • Utrecht 木瓜福利影视, The Netherlands - coordinator, consortium lead
  • Aarhus 木瓜福利影视, Denmark
  • 木瓜福利影视 of Copenhagen, Denmark
  • Klinikum der Universit盲t M眉nchen, Germany
  • Universit盲t Witten/Herdecke, Germany
  • AEMPS, Spain
  • FICF, Spain

Status

Completed (2018)

Deliverables

Peer-reviewed scientific publications


  • Ib谩帽ez L, Sabat茅 M, Vidal X, Ballarin E, Rottenkolber M, Schmiedl S, Heeke A, Huerta C, Martin Merino E, Montero D, Leon-Mu帽oz LM, Gasse C, Moore N, Droz C, Lassalle R, Aakjaer M, Andersen M, De Bruin ML, Groenwold R, van den Ham HA, Souverein P, Klungel O, Gardarsdottir H. Br J Clin Pharmacol. 2019 Nov;85(11):2524-2539. doi: 10.1111/bcp.14071. Epub 2019 Sep 4. PMID: 31318059

  • Souverein PC, van den Ham HA, Huerta C, Merino EM, Montero D, Le贸n-Mu帽oz LM, Schmiedl S, Heeke A, Rottenkolber M, Andersen M, Aakjaer M, De Bruin ML, Klungel OH, Gardarsdottir H. Br J Clin Pharmacol. 2021 Mar;87(3):988-1000. doi: 10.1111/bcp.14450. Epub 2020 Jul 13. PMID: 32627222 

  • Rottenkolber M, Schmiedl S, Ib谩nez L, Sabat茅 M, Ballar铆n E, Vidal X, Leon-Mu帽oz LM, Huerta C, Martin Merino E, Montero D, Gasse C, Andersen M, Aakjaer M, De Bruin ML, Gerlach R, Tauscher M, Souverein PC, van den Ham R, Klungel O, Gardarsdottir H; PE&PV consortium. Basic Clin Pharmacol Toxicol. 2021 Mar;128(3):440-454. doi: 10.1111/bcpt.13517. Epub 2020 Nov 2. PMID: 33037766

  • van den Ham HA, Souverein PC, Klungel OH, Platt RW, Ernst P, Dell'Aniello S, Schmiedl S, Grave B, Rottenkolber M, Huerta C, Mart铆n Merino E, Le贸n-Mu帽oz LM, Montero D, Andersen M, Aakjaer M, De Bruin ML, Gardarsdottir H. Pharmacoepidemiol Drug Saf. 2021 Oct;30(10):1339-1352. doi: 10.1002/pds.5317. Epub 2021 Jul 22. PMID: 34173286 

  • Sabat茅 M, Vidal X, Ballarin E, Rottenkolber M, Schmiedl S, Grave B, Huerta C, Martin-Merino E, Montero D, Leon-Mu帽oz LM, Gasse C, Moore N, Droz C, Lassalle R, Aakj忙r M, Andersen M, De Bruin ML, Souverein P, Klungel OH, Gardarsdottir H, Ib谩帽ez L. Front Pharmacol. 2021 Nov 3;12:682890. doi: 10.3389/fphar.2021.682890. eCollection 2021. PMID: 34803665