Atrial FibrillationABC-AFNCT03753490
ABC-Scores for Reduction of Stroke and Mortality in Atrial Fibrillation - The ABC-AF Study
A study testing ABC score guided therapy in people with Atrial Fibrillation, run by Uppsala University at 1 site in Sweden.
Trial summary
The primary study objective is to evaluate if personalized treatment by decision support, based on the biomarker-based risk prediction (ABC-scores) guided strategy, reduces the occurrence of the composite outcome of stroke or death in patients with atrial fibrillation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- ABC score guided therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,933 participants
- Where
- 1 siteSweden
- Study dates
- 25 Oct 2018to 31 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Patients with diagnosis of atrial fibrillation, including newly diagnosed, with or without current oral anticoagulant treatment
- Signed informed consent
Who cannot join
- Contraindication for any oral anticoagulant, according to the SmPC (in Sweden FASS)
- Indication for oral anticoagulant treatment beyond atrial fibrillation, e.g. venous thromboembolism and/or mechanical heart valve prosthesis
- Currently on treatment with a non-vitamin K antagonist oral anticoagulant (NOAC) and not eligible for change of NOAC drug e.g. drug-drug interactions
- Concomitant dual antiplatelet treatment
- Acute coronary syndrome (myocardial infarction or unstable angina) within the last 30 days
- Participation in anti-thrombotic pharmaceutical trial
Show all 9Show fewer
- Planned for AF ablation or AF surgery
- Haemoglobin <90 g/L
- Patients who, in the opinion of the investigator, cannot or will not comply with the requirements of the protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ABC-Risk Scores for Reduction of Stroke and Mortality in Atrial Fibrillation - a Multicenter, Registry-based, Randomized Controlled Parallel-group Open-label Study
The primary study objective is to evaluate if personalized treatment by decision support, based on the biomarker-based risk prediction (ABC-scores) guided strategy, reduces the occurrence of the composite outcome of stroke or death in patients with atrial fibrillation. Approximately 6500 patients will be randomized 1:1 to ABC risk score guided therapy or standard care.
- Conditions
- Atrial Fibrillation
- Being tested
- ABC score guided therapy, Standard care
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABC score guided therapyOther
In the ABC arm, individual treatment recommendations based on the ABC-scores for stroke and bleeding including non-vitamin K oral anticoagulant or no anticoagulant treatment, and other drugs and interventions, to improve stroke free survival.
Standard careOther
In the standard care arm, management according to local practice, national and international guidelines, including the potential use of traditional clinical risk scores for stroke and/or bleeding, anticoagulant treatment and other treatments and interventions.
| Study group | Role | What they receive |
|---|---|---|
| ABC score guided therapy | Other | Individual treatment recommendations based on the ABC-scores for stroke and bleeding. Receives: Other: ABC score guided therapy |
| Standard care | Other | Management according to local practice, national and international guidelines. Receives: Other: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of Stroke or Death
Measured: From the date of enrolment through study completion, minimum follow-up 2 years.
Secondary outcomes (6)
Major Bleeding
Measured: From the date of enrolment through study completion, minimum follow-up 2 years.
Stroke
Measured: From the date of enrolment through study completion, minimum follow-up 2 years.
Death
Measured: From the date of enrolment through study completion, minimum follow-up 2 years.
Myocardial Infarction
Measured: From the date of enrolment through study completion, minimum follow-up 2 years.
Heart Failure
Measured: From the date of enrolment through study completion, minimum follow-up 2 years.
Health Economics
Mean differences in health care cost, and 2-year quality-adjusted survival based on EuroQol-5D-5L between the treatment groups, combined into an incremental cost-effectiveness ratio.
Measured: From the date of enrolment through study completion, minimum follow-up 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2018
- Study start25 Oct 2018
- Primary completion31 May 2025
- Study completion31 May 2028 (estimated)
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.
- More trials run by Uppsala UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,933 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- Swedish Foundation for Strategic Research, Swedish Heart Lung Foundation, Roche Diagnostics GmbH, The Swedish Research Council
- Responsible party
- Sponsor
- Investigators
- Jonas Oldgren, MD, PhD, Study director, Uppsala Clinical Reseach Center, UCR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03753490
- Sponsor's protocol ID
- 1011455
- Acronym
- ABC-AF
- Status last verified
- Aug 2025
- First submitted
- 8 Nov 2018
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Oldgren J, Hijazi Z, Arheden H, Bjorkenheim A, Frykman V, Janzon M, Ravn-Fischer A, Renlund H, Sjalander A, Akerfeldt T, Wallentin L. Biomarker-Based ABC-AF Risk Scores for Personalized Treatment to Reduce Stroke or Death in Atrial Fibrillation: A Registry-Based, Multicenter, Randomized, Controlled Study. Circulation. 2025 Nov 25;152(21):1457-1469. doi: 10.1161/CIRCULATIONAHA.125.076725. Epub 2025 Aug 30.
PubMed 40884774
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ABC-Risk Scores for Reduction of Stroke and Mortality in Atrial Fibrillation - a Multicenter, Registry-based, Randomized Controlled Parallel-group Open-label Study
- ClinicalTrials.gov ID
- NCT03753490
- Acronym / sponsor ID
- ABC-AF / 1011455
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 3,933 participants (estimated)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- Swedish Foundation for Strategic Research, Swedish Heart Lung Foundation, Roche Diagnostics GmbH, The Swedish Research Council
- Study start
- 25 Oct 2018 (actual)
- Primary completion
- 31 May 2025 (actual)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 27 Nov 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.
The primary study objective is to evaluate if personalized treatment by decision support, based on the biomarker-based risk prediction (ABC-scores) guided strategy, reduces the occurrence of the composite outcome of stroke or death in patients with atrial fibrillation. Approximately 6500 patients will be randomized 1:1 to ABC risk score guided therapy or standard care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ABC score guided therapy | Other | Other: ABC score guided therapyIndividual treatment recommendations based on the ABC-scores for stroke and bleeding. |
| Standard care | Other | Other: Standard careManagement according to local practice, national and international guidelines. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with diagnosis of atrial fibrillation, including newly diagnosed, with or without current oral anticoagulant treatment
- Signed informed consent
Key exclusion criteria (9 listed)
- Contraindication for any oral anticoagulant, according to the SmPC (in Sweden FASS)
- Indication for oral anticoagulant treatment beyond atrial fibrillation, e.g. venous thromboembolism and/or mechanical heart valve prosthesis
- Currently on treatment with a non-vitamin K antagonist oral anticoagulant (NOAC) and not eligible for change of NOAC drug e.g. drug-drug interactions
- Concomitant dual antiplatelet treatment
- Acute coronary syndrome (myocardial infarction or unstable angina) within the last 30 days
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 |
|---|---|---|
| ABC score guided therapyIn the ABC arm, individual treatment recommendations based on the ABC-scores for stroke and bleeding including non-vitamin K oral anticoagulant or no anticoagulant treatment, and other drugs and interventions, to improve stroke free survival. | Other | ABC score guided therapy |
| Standard careIn the standard care arm, management according to local practice, national and international guidelines, including the potential use of traditional clinical risk scores for stroke and/or bleeding, anticoagulant treatment and other treatments and interventions. | Other | Standard care |
Primary outcome
Composite of Stroke or Death
Time frame: From the date of enrolment through study completion, minimum follow-up 2 years.
6 secondary outcomes
Major Bleeding
Time frame: From the date of enrolment through study completion, minimum follow-up 2 years.
Stroke
Time frame: From the date of enrolment through study completion, minimum follow-up 2 years.
Death
Time frame: From the date of enrolment through study completion, minimum follow-up 2 years.
Myocardial Infarction
Time frame: From the date of enrolment through study completion, minimum follow-up 2 years.
Heart Failure
Time frame: From the date of enrolment through study completion, minimum follow-up 2 years.
Health Economics
Time frame: From the date of enrolment through study completion, minimum follow-up 2 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
- Derived from this study: PubMed 40884774Oldgren J, Hijazi Z, Arheden H, Bjorkenheim A, Frykman V, Janzon M, Ravn-Fischer A, Renlund H, Sjalander A, Akerfeldt T, Wallentin L. Biomarker-Based ABC-AF Risk Scores for Personalized Treatment to Reduce Stroke or Death in Atrial Fibrillation: A Registry-Based, Multicenter, Randomized, Controlled Study. Circulation. 2025 Nov 25;152(21):1457-1469. doi: 10.1161/CIRCULATIONAHA.125.076725. Epub 2025 Aug 30.
- Individual participant dataSharing planned: No
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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.
Jonas Oldgren, MD, PhD study director
Uppsala Clinical Reseach Center, UCR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ABC score guided therapy in people with Atrial Fibrillation, run by Uppsala University 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 2 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 3 Sep 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Composite of Stroke or Death (time frame: From the date of enrolment through study completion, minimum follow-up 2 years.). 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 NCT03753490, 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 3 Sep 2025.