Thromboembolic and Bleeding Risks of Apixaban, Rivaroxaban and Dabigatran versus Warfarin in Patients with Non-Valvular Atrial Fibrillation

Study identification

• EU PAS number:
  EUPAS24422
• Study ID:
  29728
• Official title and acronym:
  Thromboembolic and Bleeding Risks of Apixaban, Rivaroxaban and Dabigatran versus Warfarin in Patients with Non-Valvular Atrial Fibrillation
• DARWIN EU® study:
  No
• Study countries:
  Taiwan
• Study description:
  Oral anticoagulants (OACs) have proven to reduce the mortality and morbidity of thromboembolic events among patients with non-valvular atrial fibrillation (NVAF). Due to the recent market entrance of NOACs, few real-world clinical studies have evaluated the treatment patterns among NVAF patients prescribed warfarin and NOACs.The main goal of this study is to compare the risk of major bleeding, and risk of stroke, including hemorrhagic and ischemic stroke, and systemic embolism (SE) among Asian NVAF patients newly initiated with warfarin versus each of the NOACs (i.e., apixaban, dabigatran, rivaroxaban) in the real-world setting. Edoxaban was reimbursed in September 2016, limited patients are expected to be available hence the drug was excluded.
• Study status:
  Planned

Research institutions and networks

Institutions

Taipei Veterans General Hospital

Study timelines

Date when funding contract was signed

Planned:30/03/2018

Actual:20/04/2018

Study start date

Planned:30/06/2018

Date of final study report

Planned:31/07/2019

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer Limited

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable