Clinical trial NCT04249401: 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)
Official title: Real-world Evidence for Non-valvular Atrial Fibrillation Patients Treated With Oral Anticoagulation in the Nordics
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Johnson & Johnson
First posted: 2020-01-31
Enrollment: 134897
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with NVAF who initiate treatment with oral anticoagulants (OACs, either VKAs or NOACs)

Brief 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 \[safety\]).


Eligibility criteria: Inclusion Criteria:

* Patients with a qualifying oral OAC dispensed during the study period
* A primary diagnosis indicative of atrial fibrillation during the baseline period

Exclusion Criteria:

* Age \< 18 years at index date
* Died on index date
* A diagnosis of valvular disease, pregnancy, transient cause of atrial fibrillation or venous thromboembolism in the baseline period or on the index date
* Hip or knee replacement surgery in the 60 days prior to or on the index date
* A dispensed prescription of heparin or fondaparinux in the 60 days prior to or on the index date
* A diagnosis of end-stage kidney disease or renal replacement therapy in the baseline period or on the index date
* More than one dispensed OAC (any dose of rivaroxaban, apixaban, dabigatran, edoxaban, or warfarin) on the index date
* A dispensed prescription of an OAC (any dose of rivaroxaban, apixaban, dabigatran, edoxaban, or warfarin) during the baseline period

Primary outcomes:
measure: Number of participants with ischemic stroke (IS) or systemic embolism (SE)
timeFrame: Retrospective analysis from 2010 - 2018
measure: Number of participants with intracranial haemorrhage (ICH)
timeFrame: Retrospective analysis from 2010 - 2018
Secondary outcomes:
Other outcomes:
Locations:
city: Multiple Locations
country: Sweden
facility: Many locations
Study officials:
References: