Real-world Comparative Effectiveness of Stroke Prevention in Patients With Atrial Fibrillation Treated With Factor Xa Non-vitamin-K Oral Anticoagulants (NOACs) vs. Phenprocoumon (ReLoaDeD)

NCT03563937 COMPLETED

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.

Details

Lead sponsor	Bayer
Status	COMPLETED
Enrolment	64920
Start date	Fri Jun 15 2018 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Tue Dec 10 2019 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Atrial Fibrillation

Interventions

• Phenprocoumon
• Apixaban
• Rivaroxaban (Xarelto, BAY59-7939)
• Edoxaban

Countries

Germany