Atrial FibrillationNCT02657616
Stroke Prophylaxis of AF-patients: Real-life Effectiveness and Safety of Novel Anticoagulants Compared to VKA
An observational study of Atrial Fibrillation and Stroke Prophylaxis, run by Institut für Pharmakoökonomie und Arzneimittellogistik e.V..
Trial summary
The central questions of the study can be summarized as follows: What stroke / death rates are the result of the use of the following treatment strategies: no anticoagulation with vitamin-k-antagonists (VKAs) or novel oral anticoagulants (NOACs), anticoagulation with VKAs and anticoagulation with NOACs (all). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Stroke Prophylaxis
- What is being tested?
- vitamin-k-antagonists and Novel oral anticoagulants
- Type of treatment
- Pill or oral medicine
- How many people
- 204,464 participants
- Where
- No sites listed yet
- Study dates
- Dec 2015to Dec 2015
- 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 analysis is based on a data set of patients with atrial fibrillation (01/01/2010 - 30/06/2014) insured by the AOK PLUS, AOK Bayern or AOK Baden-Württemberg.
Who may be able to join
- one inpatient or two outpatient confirmed diagnosis of atrial fibrillation in two different quarters
- Continuously insured by the AOK PLUS, AOK Bayern or AOK Baden-Württemberg
Who cannot join
- Age < 18 years
- Maximum possible observational period < 12 months (exception: death)
About this study
Official title: Stroke Prophylaxis of Patients With Atrial Fibrillation: Real-life Effectiveness and Safety of Novel Anticoagulants Compared to Vitamin-k-antagonists Based on an Analysis of German Claims Data
The central questions of the study can be summarized as follows:
What stroke / death rates are the result of the use of the following treatment strategies: no anticoagulation with vitamin-k-antagonists (VKAs) or novel oral anticoagulants (NOACs), anticoagulation with VKAs and anticoagulation with NOACs (all). What other thromboembolic complication rates resulting from the use of these treatment strategies? What heavy bleeding rates resulting from the defined management strategies? The analysis is based on a data set of patients with atrial fibrillation (AF)(01/01/2010 - 30/06/2014). 2010 is used as the reference period and 01/01/2011-30/06/2013 as the inclusion period. The minimum observation time per patient is 12 months.
Read more
Used is a data base of the AOK PLUS as well as the AOK Baden-Württemberg and AOK Bayern.
The aim of the study is to compare clinical outcomes between the different treatment strategies (frequency of events and time to first event). The influence of alternative treatment strategies is measured on the basis of three different methodological approaches: unadjusted comparison of event council and time to first event between the defined patient groups; matched-pair comparison (propensity score matching) between the different groups of patients (treatment strategies) and multivariate analysis using time to event (Cox proportional hazards model) as the dependent variable.
- Conditions
- Atrial Fibrillation, Stroke Prophylaxis
- Being tested
- vitamin-k-antagonists, Novel oral anticoagulants
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitamin-k-antagonistsDrug
Novel oral anticoagulantsDrug
| Study group | Role | What they receive |
|---|---|---|
| No anticoagulation with VKA/NOAC | No prescriptions of vitamin-k-antagonists/novel anticoagulants in all observational period; No prescriptions of low molecular weight heparins/Clopidogrel during observation period to the extent of more than 30 days. | |
| Anticoagulation with vitamin-k-antagonists | The patient should be treated stable during the observation period with vitamin-k-antagonists (at least one prescription per half-year). The patient should be not been around on other anticoagulants during the observation period. This means that no prescriptions of novel anticoagulants and not more than 30 days should be observable prescriptions of low molecular weight heparins/Clopidogrel per year. Receives: Drug: vitamin-k-antagonists | |
| Anticoagulation with novel oral anticoagulants | The patient should be treated stable during the observation period with a novel anticoagulant (at least one prescription per half-year). This means that no vitamin-k-antagonists prescriptions and not more than 30 days should be observable prescriptions of low molecular weight heparins/Clopidogrel per year from the start of the observation period. Receives: Drug: Novel oral anticoagulants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death
Measured: 01/01/2011-30/06/2014; at least 12 months; up to 40 months
Transient ischemic attack
Measured: 01/01/2011-30/06/2014; at least 12 months; up to 40 months
Ischemic stroke
Measured: 01/01/2011-30/06/2014; at least 12 months; up to 40 months
Hemorrhagic stroke
Measured: 01/01/2011-30/06/2014; at least 12 months; up to 40 months
Heavy bleeding
Measured: 01/01/2011-30/06/2014; at least 12 months; up to 40 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2016 (estimated)
- Study startDec 2015
- Primary completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- 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
- 204,464 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut für Pharmakoökonomie und Arzneimittellogistik e.V.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sabrina Müller, Institut für Pharmakoökonomie und Arzneimittellogistik e.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02657616
- Sponsor's protocol ID
- NOAC001
- Status last verified
- Jan 2016
- First submitted
- 11 Jan 2016
- Last updated
- 18 Jan 2016
- Results posted
- No
Publications
Mueller S, Groth A, Spitzer SG, Schramm A, Pfaff A, Maywald U. Real-world effectiveness and safety of oral anticoagulation strategies in atrial fibrillation: a cohort study based on a German claims dataset. Pragmat Obs Res. 2018 May 1;9:1-10. doi: 10.2147/POR.S156521. eCollection 2018.
PubMed 29750067
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stroke Prophylaxis of Patients With Atrial Fibrillation: Real-life Effectiveness and Safety of Novel Anticoagulants Compared to Vitamin-k-antagonists Based on an Analysis of German Claims Data
- ClinicalTrials.gov ID
- NCT02657616
- Acronym / sponsor ID
- NOAC001
- Conditions
- Atrial Fibrillation, Stroke Prophylaxis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 204,464 participants (actual)
- Lead sponsor
- Institut für Pharmakoökonomie und Arzneimittellogistik e.V.University, hospital or other
- Study start
- Dec 2015
- Primary completion
- Dec 2015 (actual)
- First posted
- 18 Jan 2016 (estimated)
- 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.
The central questions of the study can be summarized as follows:
What stroke / death rates are the result of the use of the following treatment strategies: no anticoagulation with vitamin-k-antagonists (VKAs) or novel oral anticoagulants (NOACs), anticoagulation with VKAs and anticoagulation with NOACs (all). What other thromboembolic complication rates resulting from the use of these treatment strategies? What heavy bleeding rates resulting from the defined management strategies? The analysis is based on a data set of patients with atrial fibrillation (AF)(01/01/2010 - 30/06/2014). 2010 is used as the reference period and 01/01/2011-30/06/2013 as the inclusion period. The minimum observation time per patient is 12 months.
Used is a data base of the AOK PLUS as well as the AOK Baden-Württemberg and AOK Bayern.
The aim of the study is to compare clinical outcomes between the different treatment strategies (frequency of events and time to first event). The influence of alternative treatment strategies is measured on the basis of three different methodological approaches: unadjusted comparison of event council and time to first event between the defined patient groups; matched-pair comparison (propensity score matching) between the different groups of patients (treatment strategies) and multivariate analysis using time to event (Cox proportional hazards model) as the dependent variable.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No anticoagulation with VKA/NOAC | – | –No prescriptions of vitamin-k-antagonists/novel anticoagulants in all observational period; No prescriptions of low molecular weight heparins/Clopidogrel during observation period to the extent of more than 30 days. |
| Anticoagulation with vitamin-k-antagonists | – | Drug: vitamin-k-antagonistsThe patient should be treated stable during the observation period with vitamin-k-antagonists (at least one prescription per half-year). The patient should be not been around on other anticoagulants during the observation period. This means that no prescriptions of novel anticoagulants and not more than 30 days should be observable prescriptions of low molecular weight heparins/Clopidogrel per year. |
| Anticoagulation with novel oral anticoagulants | – | Drug: Novel oral anticoagulantsThe patient should be treated stable during the observation period with a novel anticoagulant (at least one prescription per half-year). This means that no vitamin-k-antagonists prescriptions and not more than 30 days should be observable prescriptions of low molecular weight heparins/Clopidogrel per year from the start of the observation period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The analysis is based on a data set of patients with atrial fibrillation (01/01/2010 - 30/06/2014) insured by the AOK PLUS, AOK Bayern or AOK Baden-Württemberg.
Key inclusion criteria (2 listed)
- one inpatient or two outpatient confirmed diagnosis of atrial fibrillation in two different quarters
- Continuously insured by the AOK PLUS, AOK Bayern or AOK Baden-Württemberg
Key exclusion criteria (2 listed)
- Age < 18 years
- Maximum possible observational period < 12 months (exception: death)
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 |
|---|---|---|
| vitamin-k-antagonists | Drug | Anticoagulation with vitamin-k-antagonists |
| Novel oral anticoagulants | Drug | Anticoagulation with novel oral anticoagulants |
Primary outcome
Death
Time frame: 01/01/2011-30/06/2014; at least 12 months; up to 40 months
Transient ischemic attack
Time frame: 01/01/2011-30/06/2014; at least 12 months; up to 40 months
Ischemic stroke
Time frame: 01/01/2011-30/06/2014; at least 12 months; up to 40 months
Hemorrhagic stroke
Time frame: 01/01/2011-30/06/2014; at least 12 months; up to 40 months
Heavy bleeding
Time frame: 01/01/2011-30/06/2014; at least 12 months; up to 40 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2016.
- Derived from this study: PubMed 29750067Mueller S, Groth A, Spitzer SG, Schramm A, Pfaff A, Maywald U. Real-world effectiveness and safety of oral anticoagulation strategies in atrial fibrillation: a cohort study based on a German claims dataset. Pragmat Obs Res. 2018 May 1;9:1-10. doi: 10.2147/POR.S156521. eCollection 2018.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Stroke Prophylaxis, run by Institut für Pharmakoökonomie und Arzneimittellogistik e.V..
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 18 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Death (time frame: 01/01/2011-30/06/2014; at least 12 months; up to 40 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02657616, which also lists 1 linked publication.
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 18 Jan 2016.