NCT03715725

A Nationwide Observational Study Looking at Effectiveness and Bleeding Complications of NOACs vs. VKA in Non-valvular Atrial Fibrillation Patients.

A Post-marketing Retrospective Non-interventional Study Using Nationwide Registries and Electronic Medical Records to Investigate the Real-life Effectiveness and Major Bleeding Complications of Oral Anticoagulants in Norwegian Non-valvular Atrial Fibrillation Patients

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 70,000 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Using mandatory nationwide registries and possibly hospital electronic medical records in Norway, the researchers want to understand how well a group of drugs called "non-vitamin K antagonist oral anticoagulants" (rivaroxaban - Xarelto; apixaban - Eliquis; dabigatran - Pradaxa) works in patients with non-valvular atrial fibrillation (this is a condition when the heart beats irregularly) compared to another older drug, a vitamin K antagonist oral anticoagulants (warfarin) and how safe these drugs are. The primary objective of the study is to assess the occurence of an ischemic stroke (a condition when an artery that brings blood to the brain is blocked) and intracranial hemorrhage (a serious condition when a diseased blood vessel within the brain bursts).

Conditions

• Non-valvular Atrial Fibrillation

Interventions

Type	Name	Description
DRUG	Rivaroxaban (Xarelto, BAY59-7939)	Administration according to clinical practice
DRUG	Apixaban (Eliquis)	Administration according to clinical practice
DRUG	Dabigatran etexilate (Pradaxa)	Administration according to clinical practice
DRUG	Warfarin (Marevan)	Administration according to clinical practice

Timeline

• Start date: 2018-10-31
• Primary completion: 2020-01-20
• Completion: 2020-01-20
• First posted: 2018-10-23
• Last updated: 2020-12-10

Locations

1 site across 1 country: Norway