Cardiovascular DiseaseCDS-AFNCT02635685
Clinical Decision Support for Stroke Prevention in Atrial Fibrillation
A study testing Clinical Decision Support tool in people with Cardiovascular Disease and Atrial Fibrillation, run by University Hospital, Linkoeping at 1 site in Sweden.
Trial summary
A cluster randomised study in the primary care setting to evaluate a electronic clinical decision tool for stroke prophylaxis in patients with atrial fibrillation. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiovascular Disease, Atrial Fibrillation, Stroke
- What is being tested?
- Clinical Decision Support tool
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 442,105 participants
- Where
- 1 siteSweden
- Study dates
- 11 Jan 2016to 11 Jan 2025
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Primary care centers in the county of Östergötland, Sweden.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Decision Support for Stroke Prevention in Atrial Fibrillation - a Cluster Randomized Trial in the Primary Care Setting
A cluster randomised study in the primary care setting to evaluate a electronic clinical decision tool for stroke prophylaxis in patients with atrial fibrillation.
Read the detailed description
Atrial fibrillation is the most common form of arrhythmia, affecting more than three percent of the population. The condition carries an increased risk of thromboembolism, in particular stroke. In 2013 approximately 25000 acute strokes were diagnosed in Sweden, with the result of death or severe disability in nearly half of the cases. Numerous studies have shown that the risk for stroke can be reduced by approximately 60-70 % with the use of anticoagulant therapy to patients with one or several risk factors for stroke and concurrent atrial fibrillation. The European Society of Cardiology recommends use of the CHA2DS2VASc algorithm to identify persons at increased risk for stroke in the setting of atrial fibrillation. Prophylaxis is recommended if CHA2DS2VASc ≥ 1 (not only female gender).
The agents used include warfarin and the more recently developed non-vitamin k oral anticoagulants (NOACs). Despite good evidence and recommendations in current guidelines, however, there remains a substantial undertreatment in this group of patients.
The Swedish Association of Local Authorities and Regions have shown that only 63% of patients with a CHA2DS2VASc score ≥ 2 are prescribed anticoagulant therapy [7]. The reasons for this is most likely multifactorial, including ignorance of the CHA2DS2VASc algorithm as well as reluctance of the use of potent drugs from both doctors and patients. Furthermore, the high pace in modern medicine increase the risk of missing the diagnosis of atrial fibrillation and/or the conditions constituting the CHA2DS2VASc algorithm.
Clinical decision tools is a relatively new phenomena in modern medicine showing promising results, but evidence for clinical outcome are sparse. The clinical decision tool for stroke prevention (CDSS) has been developed in collaboration between Cambio Cosmic (the supplier of the electronic journal in the county of Östergötland), the Cardiology Department at Linköping University hospital and primary care professionals. The decision tool is activated when a patient is being logged into the electronic journal. If the patient has a diagnosis of atrial fibrillation (or atrial flutter) and a CHA2DS2VASc score ≥ 1 (not only female gender) without current anticoagulant therapy, a screen warning will appear. By clicking on the warning, the responsible physician will get an overview of the patient's diagnosis according to the CHA2DS2VASc algorithm. Furthermore, a calculation of the estimated stroke risk for the coming year will appear, and links to national guidelines be provided. The physician can thereafter decide to prescribe anticoagulant therapy in accordance with current guidelines or, alternatively, postpone the decision/make a decision to refrain from medication. In case the choice is made to refrain from medication the physician is asked to choose between a set of predetermined reasons in order to monitor the main reasons for deviation from guidelines.
If, on the other hand, the patient has anticoagulant therapy in accordance with current guidelines, no screen warning will appear.
CDSS has shown promising results in a pilot study conducted at five units in the County of Östergötland during the fall of 2014. The aim of the present study is to investigate this computerized decision tool in a large randomized trial in the primary care setting.
Study design The present study is a cluster randomized study in the primary care setting in the County of Östergötland, Sweden. The investigators intend to include all primary care units (n = 43) in the County of Östergötland. Participation is non-compulsory. The population in the County of Östergötland is 442 105 (December 2014)
At the time of inclusion all primary care units will be stratified in four strata based on the number of patients listed on each unit and current adherence to guidelines (i.e. the percentage of patients with a diagnosis of atrial fibrillation and CHA2DS2VASc ≥ 1 (not only female gender) that are currently prescribed anticoagulant therapy). They will thereafter be randomized to intervention with the CDSS application or serve as a control unit (continue with usual care, randomized 1:1). Prior to randomization all the participating general practitioners will receive an education about atrial fibrillation and the associated risk of stroke, including the CHA2DS2VASc algorithm and an overview of anticoagulant therapy. Furthermore, all units receiving the CDSS will have a briefing about the technical aspects of using the application.
- Conditions
- Cardiovascular Disease, Atrial Fibrillation, Stroke
- Being tested
- Clinical Decision Support tool
- Keywords
- Atrial fibrillation, Stroke, Clinical Decision Support, Anticoagulants
- Medical subject headings
- Cardiovascular Diseases, Atrial Fibrillation, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical Decision Support toolOther
Automatized support tool for identification of patients with a diagnosis of atrial fibrillation without appropriate anticoagulant therapy for stroke prevention.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Intervention with Clinical Decision Support tool installed on units. Receives: Other: Clinical Decision Support tool |
| Control group | No intervention | Control group without intervention with Clinical Decision Support tool installed on units. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to guidelines defined as the percentage of patients with atrial fibrillation and CHA2DS2VASc ≥ 1, (not only female gender) that are prescribed anticoagulant therapy (ATC-code B01A).
The data will be recorded through the electronic journal where the diagnosis for atrial fibrillation/flutter, the conditions constituting the CHA2DS2VASc algorithm as well as the medication list is logged.
Measured: 12 months after study commencement
Secondary outcomes (4)
Reduction av thromboembolism. This will be analyzed through the electronic medical journal by identifying the patients with new (since commencement of the study) diagnosis of thromboembolism. ICD-10 codes I63-64, G45, I75 will be analyzed.
Measured: 12 months after study commencement and 3 and 6 years after study finish.
Analysis of physician acceptance of a clinical decision tool in the primary care setting with questionnaires to randomly assigned general physicians.
The extended Technology Acceptance Model is implemented with modifications in order to capture moderating factors of acceptance.
Measured: Before study commencement and after 12 months
Analysis of reasons to deviate from guidelines. As part of the clinical decision tool there are prespecified reasons to choose from if no therapy is prescribed. The main reasons will be summarized.
Measured: 12 months after study commencement
Cost-effectiveness of using clinical decision support tool for stroke prevention in the primary care setting.
: Resource use regarding education of general practitioners and the time for using the clinical decision support tool is going to be identified and translated into healthcare costs by assigning a unit cost.
Cost of the clinical decision support tool is also included to get the mean healthcare cost/patient.
The effectiveness measure is percentage of all patients with atrial fibrillation getting anticoagulation therapy in the clinical decision support tool group compared with the control group.
This is a trial based evaluation. We will also calculate longterm results with a modelling approach.
Measured: 12 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2015 (estimated)
- Study start11 Jan 2016
- Primary completion11 Jan 2017
- Study completion11 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 442,105 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Linkoeping
- Sponsor type
- University, hospital or other
- Collaborators
- Linkoeping University
- Responsible party
- Principal investigator, Lars Karlsson, University Hospital, Linkoeping
- Investigators
- Lars O Karlsson, MD, PhD, Principal investigator, Department of Cardiology and Department of Medical and Health Sciences, Linköping University, Linköping, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02635685
- Sponsor's protocol ID
- 2015/398-32
- Acronym
- CDS-AF
- Status last verified
- May 2023
- First submitted
- 18 Nov 2015
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Friberg L, Bergfeldt L. Atrial fibrillation prevalence revisited. J Intern Med. 2013 Nov;274(5):461-8. doi: 10.1111/joim.12114. Epub 2013 Aug 7.
PubMed 23879838Riks-stroke. Annual report 2013 (in Swedish). http://www.riksstroke.org/wp-content/uploads/2014/07/Strokerapport_AKUTTIA3man_LR.pdf. Accessed November 2014.
Hart RG, Pearce LA, Aguilar MI. Meta-analysis: antithrombotic therapy to prevent stroke in patients who have nonvalvular atrial fibrillation. Ann Intern Med. 2007 Jun 19;146(12):857-67. doi: 10.7326/0003-4819-146-12-200706190-00007.
PubMed 17577005Camm AJ, Lip GY, De Caterina R, Savelieva I, Atar D, Hohnloser SH, Hindricks G, Kirchhof P; ESC Committee for Practice Guidelines-CPG; Document Reviewers. 2012 focused update of the ESC Guidelines for the management of atrial fibrillation: an update of the 2010 ESC Guidelines for the management of atrial fibrillation--developed with the special contribution of the European Heart Rhythm Association. Europace. 2012 Oct;14(10):1385-413. doi: 10.1093/europace/eus305. Epub 2012 Aug 24. No abstract available.
PubMed 22923145Bjorck S, Palaszewski B, Friberg L, Bergfeldt L. Atrial fibrillation, stroke risk, and warfarin therapy revisited: a population-based study. Stroke. 2013 Nov;44(11):3103-8. doi: 10.1161/STROKEAHA.113.002329. Epub 2013 Aug 27.
PubMed 23982711Kakkar AK, Mueller I, Bassand JP, Fitzmaurice DA, Goldhaber SZ, Goto S, Haas S, Hacke W, Lip GY, Mantovani LG, Turpie AG, van Eickels M, Misselwitz F, Rushton-Smith S, Kayani G, Wilkinson P, Verheugt FW; GARFIELD Registry Investigators. Risk profiles and antithrombotic treatment of patients newly diagnosed with atrial fibrillation at risk of stroke: perspectives from the international, observational, prospective GARFIELD registry. PLoS One. 2013 May 21;8(5):e63479. doi: 10.1371/journal.pone.0063479. Print 2013.
PubMed 23704912Öppna jämförelser: hälso- och sjukvård 2014, del 2 (in Swedish). http://webbutik.skl.se/sv/artiklar/oppna-jamforelser-halso-och-sjukvard-2014-del-1.html. Accessed December 4, 2014.
Lobach D, Sanders GD, Bright TJ, Wong A, Dhurjati R, Bristow E, Bastian L, Coeytaux R, Samsa G, Hasselblad V, Williams JW, Wing L, Musty M, Kendrick AS. Enabling health care decisionmaking through clinical decision support and knowledge management. Evid Rep Technol Assess (Full Rep). 2012 Apr;(203):1-784.
PubMed 23126650Bright TJ, Wong A, Dhurjati R, Bristow E, Bastian L, Coeytaux RR, Samsa G, Hasselblad V, Williams JW, Musty MD, Wing L, Kendrick AS, Sanders GD, Lobach D. Effect of clinical decision-support systems: a systematic review. Ann Intern Med. 2012 Jul 3;157(1):29-43. doi: 10.7326/0003-4819-157-1-201207030-00450.
PubMed 22751758Persson Lindell O, Henriksson M, Karlsson LO, Nilsson S, Charitakis E, Janzon M. Cost-effectiveness of a clinical decision support system for atrial fibrillation: an RCT-based modelling study. Eur Heart J Digit Health. 2025 Aug 1;6(5):997-1005. doi: 10.1093/ehjdh/ztaf087. eCollection 2025 Sep.
PubMed 40984984Karlsson LO, Nilsson S, Bang M, Nilsson L, Charitakis E, Janzon M. A clinical decision support tool for improving adherence to guidelines on anticoagulant therapy in patients with atrial fibrillation at risk of stroke: A cluster-randomized trial in a Swedish primary care setting (the CDS-AF study). PLoS Med. 2018 Mar 13;15(3):e1002528. doi: 10.1371/journal.pmed.1002528. eCollection 2018 Mar.
PubMed 29534063
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Decision Support for Stroke Prevention in Atrial Fibrillation - a Cluster Randomized Trial in the Primary Care Setting
- ClinicalTrials.gov ID
- NCT02635685
- Acronym / sponsor ID
- CDS-AF / 2015/398-32
- Conditions
- Cardiovascular Disease, Atrial Fibrillation, Stroke
- Keywords
- Atrial fibrillation, Stroke, Clinical Decision Support, Anticoagulants
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 442,105 participants (actual)
- Lead sponsor
- University Hospital, LinkoepingUniversity, hospital or other
- Collaborators
- Linkoeping University
- Study start
- 11 Jan 2016 (actual)
- Primary completion
- 11 Jan 2017 (actual)
- Study completion
- 11 Jan 2025 (estimated)
- First posted
- 21 Dec 2015 (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.
A cluster randomised study in the primary care setting to evaluate a electronic clinical decision tool for stroke prophylaxis in patients with atrial fibrillation.
Detailed description
Atrial fibrillation is the most common form of arrhythmia, affecting more than three percent of the population. The condition carries an increased risk of thromboembolism, in particular stroke. In 2013 approximately 25000 acute strokes were diagnosed in Sweden, with the result of death or severe disability in nearly half of the cases. Numerous studies have shown that the risk for stroke can be reduced by approximately 60-70 % with the use of anticoagulant therapy to patients with one or several risk factors for stroke and concurrent atrial fibrillation. The European Society of Cardiology recommends use of the CHA2DS2VASc algorithm to identify persons at increased risk for stroke in the setting of atrial fibrillation. Prophylaxis is recommended if CHA2DS2VASc ≥ 1 (not only female gender).
The agents used include warfarin and the more recently developed non-vitamin k oral anticoagulants (NOACs). Despite good evidence and recommendations in current guidelines, however, there remains a substantial undertreatment in this group of patients.
The Swedish Association of Local Authorities and Regions have shown that only 63% of patients with a CHA2DS2VASc score ≥ 2 are prescribed anticoagulant therapy [7]. The reasons for this is most likely multifactorial, including ignorance of the CHA2DS2VASc algorithm as well as reluctance of the use of potent drugs from both doctors and patients. Furthermore, the high pace in modern medicine increase the risk of missing the diagnosis of atrial fibrillation and/or the conditions constituting the CHA2DS2VASc algorithm.
Clinical decision tools is a relatively new phenomena in modern medicine showing promising results, but evidence for clinical outcome are sparse. The clinical decision tool for stroke prevention (CDSS) has been developed in collaboration between Cambio Cosmic (the supplier of the electronic journal in the county of Östergötland), the Cardiology Department at Linköping University hospital and primary care professionals. The decision tool is activated when a patient is being logged into the electronic journal. If the patient has a diagnosis of atrial fibrillation (or atrial flutter) and a CHA2DS2VASc score ≥ 1 (not only female gender) without current anticoagulant therapy, a screen warning will appear. By clicking on the warning, the responsible physician will get an overview of the patient's diagnosis according to the CHA2DS2VASc algorithm. Furthermore, a calculation of the estimated stroke risk for the coming year will appear, and links to national guidelines be provided. The physician can thereafter decide to prescribe anticoagulant therapy in accordance with current guidelines or, alternatively, postpone the decision/make a decision to refrain from medication. In case the choice is made to refrain from medication the physician is asked to choose between a set of predetermined reasons in order to monitor the main reasons for deviation from guidelines.
If, on the other hand, the patient has anticoagulant therapy in accordance with current guidelines, no screen warning will appear.
CDSS has shown promising results in a pilot study conducted at five units in the County of Östergötland during the fall of 2014. The aim of the present study is to investigate this computerized decision tool in a large randomized trial in the primary care setting.
Study design The present study is a cluster randomized study in the primary care setting in the County of Östergötland, Sweden. The investigators intend to include all primary care units (n = 43) in the County of Östergötland. Participation is non-compulsory. The population in the County of Östergötland is 442 105 (December 2014)
At the time of inclusion all primary care units will be stratified in four strata based on the number of patients listed on each unit and current adherence to guidelines (i.e. the percentage of patients with a diagnosis of atrial fibrillation and CHA2DS2VASc ≥ 1 (not only female gender) that are currently prescribed anticoagulant therapy). They will thereafter be randomized to intervention with the CDSS application or serve as a control unit (continue with usual care, randomized 1:1). Prior to randomization all the participating general practitioners will receive an education about atrial fibrillation and the associated risk of stroke, including the CHA2DS2VASc algorithm and an overview of anticoagulant therapy. Furthermore, all units receiving the CDSS will have a briefing about the technical aspects of using the application.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Clinical Decision Support toolIntervention with Clinical Decision Support tool installed on units. |
| Control group | No intervention | –Control group without intervention with Clinical Decision Support tool installed on units. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Primary care centers in the county of Östergötland, Sweden.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Clinical Decision Support toolAutomatized support tool for identification of patients with a diagnosis of atrial fibrillation without appropriate anticoagulant therapy for stroke prevention. | Other | Intervention group |
Primary outcome
Adherence to guidelines defined as the percentage of patients with atrial fibrillation and CHA2DS2VASc ≥ 1, (not only female gender) that are prescribed anticoagulant therapy (ATC-code B01A).
Time frame: 12 months after study commencement
The data will be recorded through the electronic journal where the diagnosis for atrial fibrillation/flutter, the conditions constituting the CHA2DS2VASc algorithm as well as the medication list is logged.
4 secondary outcomes
Reduction av thromboembolism. This will be analyzed through the electronic medical journal by identifying the patients with new (since commencement of the study) diagnosis of thromboembolism. ICD-10 codes I63-64, G45, I75 will be analyzed.
Time frame: 12 months after study commencement and 3 and 6 years after study finish.
Analysis of physician acceptance of a clinical decision tool in the primary care setting with questionnaires to randomly assigned general physicians.
Time frame: Before study commencement and after 12 months
Analysis of reasons to deviate from guidelines. As part of the clinical decision tool there are prespecified reasons to choose from if no therapy is prescribed. The main reasons will be summarized.
Time frame: 12 months after study commencement
Cost-effectiveness of using clinical decision support tool for stroke prevention in the primary care setting.
Time frame: 12 months follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- Background: PubMed 23879838Friberg L, Bergfeldt L. Atrial fibrillation prevalence revisited. J Intern Med. 2013 Nov;274(5):461-8. doi: 10.1111/joim.12114. Epub 2013 Aug 7.
- BackgroundRiks-stroke. Annual report 2013 (in Swedish). http://www.riksstroke.org/wp-content/uploads/2014/07/Strokerapport_AKUTTIA3man_LR.pdf. Accessed November 2014.
- Background: PubMed 17577005Hart RG, Pearce LA, Aguilar MI. Meta-analysis: antithrombotic therapy to prevent stroke in patients who have nonvalvular atrial fibrillation. Ann Intern Med. 2007 Jun 19;146(12):857-67. doi: 10.7326/0003-4819-146-12-200706190-00007.
- Background: PubMed 22923145Camm AJ, Lip GY, De Caterina R, Savelieva I, Atar D, Hohnloser SH, Hindricks G, Kirchhof P; ESC Committee for Practice Guidelines-CPG; Document Reviewers. 2012 focused update of the ESC Guidelines for the management of atrial fibrillation: an update of the 2010 ESC Guidelines for the management of atrial fibrillation--developed with the special contribution of the European Heart Rhythm Association. Europace. 2012 Oct;14(10):1385-413. doi: 10.1093/europace/eus305. Epub 2012 Aug 24. No abstract available.
- Background: PubMed 23982711Bjorck S, Palaszewski B, Friberg L, Bergfeldt L. Atrial fibrillation, stroke risk, and warfarin therapy revisited: a population-based study. Stroke. 2013 Nov;44(11):3103-8. doi: 10.1161/STROKEAHA.113.002329. Epub 2013 Aug 27.
- Background: PubMed 23704912Kakkar AK, Mueller I, Bassand JP, Fitzmaurice DA, Goldhaber SZ, Goto S, Haas S, Hacke W, Lip GY, Mantovani LG, Turpie AG, van Eickels M, Misselwitz F, Rushton-Smith S, Kayani G, Wilkinson P, Verheugt FW; GARFIELD Registry Investigators. Risk profiles and antithrombotic treatment of patients newly diagnosed with atrial fibrillation at risk of stroke: perspectives from the international, observational, prospective GARFIELD registry. PLoS One. 2013 May 21;8(5):e63479. doi: 10.1371/journal.pone.0063479. Print 2013.
- BackgroundÖppna jämförelser: hälso- och sjukvård 2014, del 2 (in Swedish). http://webbutik.skl.se/sv/artiklar/oppna-jamforelser-halso-och-sjukvard-2014-del-1.html. Accessed December 4, 2014.
- Background: PubMed 23126650Lobach D, Sanders GD, Bright TJ, Wong A, Dhurjati R, Bristow E, Bastian L, Coeytaux R, Samsa G, Hasselblad V, Williams JW, Wing L, Musty M, Kendrick AS. Enabling health care decisionmaking through clinical decision support and knowledge management. Evid Rep Technol Assess (Full Rep). 2012 Apr;(203):1-784.
- Background: PubMed 22751758Bright TJ, Wong A, Dhurjati R, Bristow E, Bastian L, Coeytaux RR, Samsa G, Hasselblad V, Williams JW, Musty MD, Wing L, Kendrick AS, Sanders GD, Lobach D. Effect of clinical decision-support systems: a systematic review. Ann Intern Med. 2012 Jul 3;157(1):29-43. doi: 10.7326/0003-4819-157-1-201207030-00450.
- Derived from this study: PubMed 40984984Persson Lindell O, Henriksson M, Karlsson LO, Nilsson S, Charitakis E, Janzon M. Cost-effectiveness of a clinical decision support system for atrial fibrillation: an RCT-based modelling study. Eur Heart J Digit Health. 2025 Aug 1;6(5):997-1005. doi: 10.1093/ehjdh/ztaf087. eCollection 2025 Sep.
- Derived from this study: PubMed 29534063Karlsson LO, Nilsson S, Bang M, Nilsson L, Charitakis E, Janzon M. A clinical decision support tool for improving adherence to guidelines on anticoagulant therapy in patients with atrial fibrillation at risk of stroke: A cluster-randomized trial in a Swedish primary care setting (the CDS-AF study). PLoS Med. 2018 Mar 13;15(3):e1002528. doi: 10.1371/journal.pmed.1002528. eCollection 2018 Mar.
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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.
Lars O Karlsson, MD, PhD principal investigator
Department of Cardiology and Department of Medical and Health Sciences, Linköping University, Linköping, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical Decision Support tool in people with Cardiovascular Disease and Atrial Fibrillation, run by University Hospital, Linkoeping at 1 site in Sweden.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 10 May 2023. 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 Sweden. 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?
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?
Adherence to guidelines defined as the percentage of patients with atrial fibrillation and CHA2DS2VASc ≥ 1, (not only female gender) that are prescribed anticoagulant therapy (ATC-code B01A). (time frame: 12 months after study commencement). 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 NCT02635685, which also lists 11 linked publications.
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 May 2023.