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| Name | Class |
|---|---|
| Swedish Foundation for Strategic Research | OTHER |
| Swedish Heart Lung Foundation | OTHER |
| Roche Diagnostics GmbH | INDUSTRY |
| The Swedish Research Council |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABC score guided therapy | Other | Individual treatment recommendations based on the ABC-scores for stroke and bleeding. |
|
| Standard care | Other | Management according to local practice, national and international guidelines. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABC score guided therapy | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Composite of Stroke or Death | From the date of enrolment through study completion, minimum follow-up 2 years. |
| Measure | Description | Time Frame |
|---|---|---|
| Major Bleeding | From the date of enrolment through study completion, minimum follow-up 2 years. | |
| Stroke | From the date of enrolment through study completion, minimum follow-up 2 years. | |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jonas Oldgren, MD, PhD | Uppsala Clinical Reseach Center, UCR | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Uppsala University Hospital | Uppsala | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40884774 | Derived | 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. |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| OTHER_GOV |
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| Standard care | Other | 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. |
|
| Death |
| From the date of enrolment through study completion, minimum follow-up 2 years. |
| Myocardial Infarction | From the date of enrolment through study completion, minimum follow-up 2 years. |
| Heart Failure | 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. | From the date of enrolment through study completion, minimum follow-up 2 years. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |