Non-valvular Atrial FibrillationPROTECT-AFNCT03715725
A Nationwide Observational Study Looking at Effectiveness and Bleeding Complications of NOACs vs. VKA in Non-valvular Atrial Fibrillation Patients.
An observational study of Non-valvular Atrial Fibrillation, run by Bayer at 1 site in Norway.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-valvular Atrial Fibrillation
- What is being tested?
- Rivaroxaban (Xarelto, BAY59-7939), Apixaban (Eliquis) and Dabigatran etexilate (Pradaxa)
- How many people
- 70,000 participants
- Where
- 1 siteNorway
- Study dates
- 31 Oct 2018to 20 Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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).
Who may be able to join
- Registry cohort (Cohort 1)
- 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:
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- 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).
Who cannot join
- Valvular atrial fibrillation defined as presence of ICD10 codes in NPR; I05.2 mitral stenosis with insufficiency, I05.8 other mitral valve diseases (mitral (valve) failure), I342 (non-rheumatic mitral valve stenosis), Z952 (presence of prosthetic heart valve) and procedure codes FKD (prosthetic replacement of mitral valve), FKA (Repair of mitral valve for stenosis), FKB (Annuloplasty of mitral valve for insufficiency), FKC (Repair of mitral valve for insufficiency), FKW (Other operations on mitral valve) and FMD (replacement of aortic valve).
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Post-marketing Retrospective Non-interventional Study Using Nationwide Registries and Electronic Medical Records to Investigate the Real-life Effectiveness and Major Bleeding Complications of Oral Anticoagulants in Norwegian Non-valvular Atrial Fibrillation Patients
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).
- Conditions
- Non-valvular Atrial Fibrillation
- Being tested
- Rivaroxaban (Xarelto, BAY59-7939), Apixaban (Eliquis), Dabigatran etexilate (Pradaxa), Warfarin (Marevan)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rivaroxaban (Xarelto, BAY59-7939)Drug
Administration according to clinical practice
Apixaban (Eliquis)Drug
Administration according to clinical practice
Dabigatran etexilate (Pradaxa)Drug
Administration according to clinical practice
Warfarin (Marevan)Drug
Administration according to clinical practice
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Rivaroxaban (Xarelto, BAY59-7939); Drug: Apixaban (Eliquis); Drug: Dabigatran etexilate (Pradaxa); Drug: Warfarin (Marevan) | |
| 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). Receives: Drug: Rivaroxaban (Xarelto, BAY59-7939); Drug: Apixaban (Eliquis); Drug: Dabigatran etexilate (Pradaxa); Drug: Warfarin (Marevan) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ischemic stroke
Ischemic stroke is defined by the following ICD10 (International Classification of Diseases) codes:
I63x: Cerebral infarction
Measured: 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
Measured: Retrospective analysis from 1 January 2014 to 30 June 2018
Secondary outcomes (8)
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
Measured: 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
Measured: 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
Measured: Retrospective analysis from 1 January 2014 to 30 June 2018
All-cause mortality
Measured: 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.
Measured: Retrospective analysis from 1 January 2014 to 30 June 2018
Demographic characteristics
Measured: 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
Measured: Retrospective analysis from 1 January 2014 to 30 June 2018
Drug utilization patterns
Measured: Retrospective analysis from 1 January 2014 to 30 June 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2018
- Study start31 Oct 2018
- Primary completion20 Jan 2020
- Study completion20 Jan 2020
Why it stopped: After feasibility assessment and due to delays in data receipt study was terminated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-valvular Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 70,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Janssen Research & Development, LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03715725
- Sponsor's protocol ID
- 19468
- Acronym
- PROTECT-AF
- Status last verified
- Dec 2020
- First submitted
- 19 Oct 2018
- Last updated
- 10 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-marketing Retrospective Non-interventional Study Using Nationwide Registries and Electronic Medical Records to Investigate the Real-life Effectiveness and Major Bleeding Complications of Oral Anticoagulants in Norwegian Non-valvular Atrial Fibrillation Patients
- ClinicalTrials.gov ID
- NCT03715725
- Acronym / sponsor ID
- PROTECT-AF / 19468
- Conditions
- Non-valvular Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: After feasibility assessment and due to delays in data receipt study was terminated
- Enrolment
- 70,000 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Collaborators
- Janssen Research & Development, LLC
- Study start
- 31 Oct 2018 (actual)
- Primary completion
- 20 Jan 2020 (actual)
- Study completion
- 20 Jan 2020 (actual)
- First posted
- 23 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Registry cohort | – | Drug: Rivaroxaban (Xarelto, BAY59-7939), Drug: Apixaban (Eliquis), Drug: Dabigatran etexilate (Pradaxa), Drug: Warfarin (Marevan)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. |
| Electronic Medical Records (EMR) cohort | – | 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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).
Key inclusion criteria (13 listed)
- Registry cohort (Cohort 1)
- 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).
- Age ≥18 at the beginning of the study period (1 January 2014).
Key exclusion criteria (3 listed)
- Valvular atrial fibrillation defined as presence of ICD10 codes in NPR; I05.2 mitral stenosis with insufficiency, I05.8 other mitral valve diseases (mitral (valve) failure), I342 (non-rheumatic mitral valve stenosis), Z952 (presence of prosthetic heart valve) and procedure codes FKD (prosthetic replacement of mitral valve), FKA (Repair of mitral valve for stenosis), FKB (Annuloplasty of mitral valve for insufficiency), FKC (Repair of mitral valve for insufficiency), FKW (Other operations on mitral valve) and FMD (replacement of aortic valve).
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rivaroxaban (Xarelto, BAY59-7939)Administration according to clinical practice | Drug | Electronic Medical Records (EMR) cohort, Registry cohort |
| Apixaban (Eliquis)Administration according to clinical practice | Drug | Electronic Medical Records (EMR) cohort, Registry cohort |
| Dabigatran etexilate (Pradaxa)Administration according to clinical practice | Drug | Electronic Medical Records (EMR) cohort, Registry cohort |
| Warfarin (Marevan)Administration according to clinical practice | Drug | Electronic Medical Records (EMR) cohort, Registry cohort |
Primary outcome
Ischemic stroke
Time frame: Retrospective analysis from 1 January 2014 to 30 June 2018
Ischemic stroke is defined by the following ICD10 (International Classification of Diseases) codes: I63x: Cerebral infarction
Intracranial hemorrhage
Time frame: Retrospective analysis from 1 January 2014 to 30 June 2018
Intracranial haemorrhage (ICH) is defined by the following ICD10 codes: I60x Subarachnoid haemorrhage I61x Intracerebral haemorrhage I62x Other non-traumatic intracranial haemorrhage
8 secondary outcomes
Overall stroke
Time frame: Retrospective analysis from 1 January 2014 to 30 June 2018
Systemic embolism
Time frame: Retrospective analysis from 1 January 2014 to 30 June 2018
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
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
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
Results and safety
The study was stopped early (reason given: After feasibility assessment and due to delays in data receipt study was terminated). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-valvular Atrial Fibrillation, run by Bayer at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: After feasibility assessment and due to delays in data receipt study was terminated). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ischemic stroke (time frame: Retrospective analysis from 1 January 2014 to 30 June 2018). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2020.