An observational study in Non-valvular Atrial Fibrillation, sponsored by Bayer. Terminated at 1 site in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-12-10.
Sponsored by Bayer · Observational
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).
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
This study's enrollment of 70,000 is above the median of 300 across 1,363 observational studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.
Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.
Counted across the registry records on this site, refreshed daily.
The study population will comprise all adult OAC naïve NVAF patients in Norway who filled a prescription for an OAC (rivaroxaban, apixaban, dabigatran, warfarin) in the study period, defined as from 1 January 2014 to 30 June 2018 (or later depending on availability of data) and followed until outcome of interest, the end of the study period or death. This initiation of an OAC is the index event and requires that there is no previous prescription dispensed for an OAC in the preceding 365 days (from end date of OAC supply to date of new OAC dispensation).
Registry cohort (Cohort 1)
Cohort 1a:
Cohort 1b:
EMR cohort (Cohort 2):
Exclusion Criteria:
Registries in Norway are nation-wide and provision of the information is mandatory, which eliminates the risk of both selection and re-call bias. The large and detailed dataset also makes it possible to adjust for other risk factors on which information is available.
Drug: Rivaroxaban (Xarelto, BAY59-7939) · Drug: Apixaban (Eliquis) · Drug: Dabigatran etexilate (Pradaxa) · Drug: Warfarin (Marevan)
Patients with NVAF diagnosis will be identified through extraction of patient-level data from EMRs from a number of hospitals in Norway, in order to describe these patients more closely regarding their clinical characteristics that are not available in nation-wide registers (e.g., in-patient treatments, anthropometric data and laboratory test results).
Drug: Rivaroxaban (Xarelto, BAY59-7939) · Drug: Apixaban (Eliquis) · Drug: Dabigatran etexilate (Pradaxa) · Drug: Warfarin (Marevan)
Administration according to clinical practice
Administration according to clinical practice
Administration according to clinical practice
Administration according to clinical practice
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
This study is terminated, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
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