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Study to Gather Information About the Safety of Oral Anticoagulation Drugs and How Well These Drugs Work in Real World for Patients With Non-valvular Atrial Fibrillation (Irregularly Heart Beats Which is Not Caused by a Heart Valve Problem)

NCT04249401 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 134897

Last updated 2024-08-01

No results posted yet for this study

Summary

Oral anticoagulant (OAC) treatment with either vitamin K antagonists (VKAs) or non-vitamin K antagonist oral anticoagulants (NOACs) is essential in patients with atrial fibrillation for the prevention of stroke or systemic embolism (SE) a condition that happens when a blood clot forms elsewhere in the body and travels through the blood stream to plug another vessel. While there are significant number of real-world publications on the use and outcomes of NOACs for stroke prevention, evidence from routine clinical practice on the use and outcomes of reduced doses of NOACs is scarce. By evaluating routine clinical practice data from national registers in Denmark, Finland, Norway and Sweden, researchers want to gather information about the safety and how well reduced doses of NOACs work in patients with irregularly heartbeats which are not caused by a heart valve problem (non-valvular atrial fibrillation, NVAF). As a primary aim of this study, treatment with low doses of NOACs (Xarelto \[generic name rivaroxaban\], Eliquis \[generic name apixaban\] or Pradaxa \[generic name dabigatran\]) will be compared with VKAs (warfarin) in Nordic patients with NVAF to assess the occurrence of stroke and systemic embolism \[effectiveness\]) and intracranial hemorrhage a type of bleeding that occurs inside the skull \[safety\]).

Conditions

Interventions

DRUG

Rivaroxaban (Xarelto)

NOAC, reduced dose

DRUG

Apixaban

NOAC, reduced dose

DRUG

Dabigatran

NOAC, reduced dose

DRUG

Warfarin

VKA

Sponsors & Collaborators

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-01
Primary Completion
2023-09-30
Completion
2023-09-30

Countries

  • Sweden

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Entities

Diseases
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 NCT04249401 on ClinicalTrials.gov