Study identification

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
First published:
01/02/2024
Institution

Contact details

Bayer Clinical Trials BAYER AG

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Bayer AG
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable