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).
Study Type
OBSERVATIONAL
Enrollment
70,000
Administration according to clinical practice
Administration according to clinical practice
Administration according to clinical practice
Administration according to clinical practice
Many Locations
Multiple Locations, Norway
Ischemic stroke
Ischemic stroke is defined by the following ICD10 (International Classification of Diseases) codes: I63x: Cerebral infarction
Time frame: Retrospective analysis from 1 January 2014 to 30 June 2018
Intracranial hemorrhage
Intracranial haemorrhage (ICH) is defined by the following ICD10 codes: I60x Subarachnoid haemorrhage I61x Intracerebral haemorrhage I62x Other non-traumatic intracranial haemorrhage
Time frame: Retrospective analysis from 1 January 2014 to 30 June 2018
Overall stroke
Overall stroke is defined by the following ICD10 codes: I60x: Subarachnoid haemorrhage I61x: Intracerebral haemorrhage I62x: Other nontraumatic intracranial haemorrhage I63x: Cerebral infarction I64x: Stroke, not specified as haemorrhage or infarction
Time frame: Retrospective analysis from 1 January 2014 to 30 June 2018
Systemic embolism
Systemic embolism is defined by the following ICD10 codes: I74x: Arterial embolism and thrombosis
Time frame: Retrospective analysis from 1 January 2014 to 30 June 2018
Myocardial infarction
Myocardial infarction is defined by the following ICD10 codes: I21x: Acute myocardial infarction I22x: Subsequent myocardial infarction
Time frame: Retrospective analysis from 1 January 2014 to 30 June 2018
All-cause mortality
Time frame: Retrospective analysis from 1 January 2014 to 30 June 2018
Major bleeding
As defined by Cunningham algorithm and Internation Society of Thrombosis and Hemostasis (ISTH) for EMR cohort.
Time frame: Retrospective analysis from 1 January 2014 to 30 June 2018
Demographic characteristics
Time frame: Retrospective analysis from 1 January 2014 to 30 June 2018
Clinical characteristics
Age, gender, CHA2DS2-VASc and HAS-BLED score, bleeding history, concomitant medications and co-morbidities
Time frame: Retrospective analysis from 1 January 2014 to 30 June 2018
Drug utilization patterns
Time frame: Retrospective analysis from 1 January 2014 to 30 June 2018
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