A Nationwide Observational Study Looking at Effectiveness and Bleeding Complications of NOACs vs. VKA in Non-valvular Atrial Fibrillation Patients.
NCT ID: NCT03715725
Last Updated: 2020-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
70000 participants
OBSERVATIONAL
2018-10-31
2020-01-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Registry cohort
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.
Rivaroxaban (Xarelto, BAY59-7939)
Administration according to clinical practice
Apixaban (Eliquis)
Administration according to clinical practice
Dabigatran etexilate (Pradaxa)
Administration according to clinical practice
Warfarin (Marevan)
Administration according to clinical practice
Electronic Medical Records (EMR) cohort
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).
Rivaroxaban (Xarelto, BAY59-7939)
Administration according to clinical practice
Apixaban (Eliquis)
Administration according to clinical practice
Dabigatran etexilate (Pradaxa)
Administration according to clinical practice
Warfarin (Marevan)
Administration according to clinical practice
Interventions
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Rivaroxaban (Xarelto, BAY59-7939)
Administration according to clinical practice
Apixaban (Eliquis)
Administration according to clinical practice
Dabigatran etexilate (Pradaxa)
Administration according to clinical practice
Warfarin (Marevan)
Administration according to clinical practice
Eligibility Criteria
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Inclusion Criteria
Cohort 1a:
* Age ≥18 at the date of first OAC (Oral Anti-Coagulants) dispensation (index date)
* Diagnosed with atrial fibrillation or flutter in the period 5-year pre-index period. Defined as ICD10 codes; I480 (paroxysmal AF), I481 (persisting AF), I482 (chronic AF), I483 (typical AF), I484 (atypical AF) or I489 (unspecified atrial fibrillation or flutter) as given by either NPR (Norwegian Patient Register) or as a OAC (warfarin, dabigatran, rivaroxaban or apixaban) dispensed on the reimbursement code for AF in NorPD (Norwegian Prescription Database) (ICD10 I48 or ICPC-2 K78)
* Dispensation of a first-time prescription for an OAC during the study period 1 January 2014 to 31 May 2018. This initiation of an OAC is the index event and requires that there is no previous prescription for any OAC in the preceding 365 days (counted from the date of the first dispensation backward to the end of OAC supply).
Cohort 1b:
* Age ≥18 at the beginning of the study period (1 January 2014).
* Diagnosed with atrial fibrillation or flutter prior or during the study period. Defined as ICD10 codes; I480 (paroxysmal AF), I481 (persisting AF), I482 (chronic AF), I483 (typical AF), I484 (atypical AF) or I489 (unspecified atrial fibrillation or flutter) as given by NPR.
* No dispensation of a prescription for an OAC (warfarin, dabigatran, rivaroxaban or apixaban) during the study period 1 January 2014 to 30 June 2018. The index event will be the beginning of the study period (1 January 2014) and requires that there is no previous prescription for an OAC in the preceding 365 days.
EMR cohort (Cohort 2):
* Age ≥18 at the date of first OAC dispensation (index date).
* Diagnosed with atrial fibrillation or flutter in the 5-year pre-index period defined as one of the following ICD10 codes in the EMRs obtained from the hospitals in the South-Eastern Health Region; I480 (paroxysmal AF), I481 (persisting AF), I482 (chronic AF), I483 (typical AF), I484 (atypical AF) or I489 (unspecified atrial fibrillation or flutter).
* Dispensation of a first-time prescription for an OAC (warfarin, dabigatran, rivaroxaban or apixaban) during the study period 1 January 2014 to 31 May 2018. This initiation of an OAC is the index event and requires that there is no previous prescription of any OAC in the preceding 365 days (counted from the date of the first dispensation backward to the end of OAC supply).
Exclusion Criteria
* Deep Venous Thrombosis (DVT) as defined by ICD10 codes I80 (Phlebitis and thrombophlebitis), Pulmonary Embolism (PE) as defined by ICD10 code I26 or I82 (other venous embolism and thrombosis), Other venous embolism and thrombosis within last 6 months before index date.
* Knee and/or hip replacement surgery (NCSP (Nordic Classification of Surgical Procedures) procedure codes; NGB, NGC, NFB or NFC) 5 weeks before index date.
18 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Bayer
INDUSTRY
Responsible Party
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Locations
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Many Locations
Multiple Locations, , Norway
Countries
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Other Identifiers
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19468
Identifier Type: -
Identifier Source: org_study_id