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

NCT03715725 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 70000

Last updated 2020-12-10

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    collaborator INDUSTRY

  • Bayer

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-31
Primary Completion
2020-01-20
Completion
2020-01-20

Countries

  • Norway

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Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03715725 on ClinicalTrials.gov