Real-world comparative effectiveness of stroke prevention in patients with atrial fibrillation treated with Factor Xa nonvitamin-K oral anticoagulants (NOACs) vs. Phenprocoumon (ReLoaDeD)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/38250
• EU PAS number:
  EUPAS24270
• Study ID:
  38250
• Official title and acronym:
  Real-world comparative effectiveness of stroke prevention in patients with atrial fibrillation treated with Factor Xa nonvitamin-K oral anticoagulants (NOACs) vs. Phenprocoumon (ReLoaDeD)
• DARWIN EU® study:
  No
• Study countries:
  Germany
• Study description:
  Existing real-world studies have provided evidence that novel oral anticoagulants (NOACs) in general and rivaroxaban in particular are more effective and at least as safe as warfarin in non-valvular atrial fibrillation (NVAF) patients with renal impairment. Nevertheless, it is known that clinicians often hesitate to prescribe NOACs to patients with even moderate renal impairment. Therefore, it is important to investigate effectiveness and safety of rivaroxaban and other NOACs compared to vitamin-K antagonists in NVAF patients with renal dysfunction in real life setting. The primary objectives of this study are to describe the risk of ischemic stroke (IS)/ systemic embolism (SE) and intracranial hemorrhage (ICH) in patients with non-valvular atrial fibrillation (NVAF) and renal impairment initiating treatment with individual NOACs (rivaroxaban, apixaban, edoxaban) compared to phenprocoumon and to assess the healthcare resource consumption and costs.
• Study status:
  Finalised

Research institutions and networks

Institutions

Bayer AG

Study timelines

Date when funding contract was signed

Planned: 30/05/2018

Actual: 30/05/2018

Study start date

Planned: 15/06/2018

Actual: 15/06/2018

Date of final study report

Planned: 17/08/2020

Actual: 31/07/2020

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Bayer AG

Study protocol

Initial protocol

OS_Protocol_ReLoaDed_Germany_v1.0_01JUNE2018_ENCePP

Updated protocol

20031_OS_Protocol_ReLoaDed_Germany_v3.0_clean_23SEP2019_blackened

Regulatory

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