NCT03563937

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 64,920 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
DRUG	Phenprocoumon	Follow the physician's prescription.
DRUG	Apixaban	2.5 mg or 5 mg, twice daily
DRUG	Rivaroxaban (Xarelto, BAY59-7939)	15 mg or 20 mg, once daily
DRUG	Edoxaban	30 mg or 60 mg, once daily

Timeline

• Start date: 2018-06-15
• Primary completion: 2019-12-10
• Completion: 2019-12-10
• First posted: 2018-06-20
• Last updated: 2020-11-27

Locations

1 site across 1 country: Germany