Atrial Fibrillation
Conditions
Brief 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. Approximately 6500 patients will be randomized 1:1 to ABC risk score guided therapy or standard care.
Interventions
OTHERABC score guided therapy
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.
OTHERStandard care
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.
Sponsors
Swedish Foundation for Strategic Research
Swedish Heart Lung Foundation
Roche Diagnostics GmbH
The Swedish Research Council
Uppsala University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients with diagnosis of atrial fibrillation, including newly diagnosed, with or without current oral anticoagulant treatment 2. Signed informed consent
Exclusion criteria
1. Contraindication for any oral anticoagulant, according to the SmPC (in Sweden FASS) 2. Indication for oral anticoagulant treatment beyond atrial fibrillation, e.g. venous thromboembolism and/or mechanical heart valve prosthesis 3. 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 4. Concomitant dual antiplatelet treatment 5. Acute coronary syndrome (myocardial infarction or unstable angina) within the last 30 days 6. Participation in anti-thrombotic pharmaceutical trial 7. Planned for AF ablation or AF surgery 8. Haemoglobin \<90 g/L 9. Patients who, in the opinion of the investigator, cannot or will not comply with the requirements of the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite of Stroke or Death | From the date of enrolment through study completion, minimum follow-up 2 years. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stroke | From the date of enrolment through study completion, minimum follow-up 2 years. | — |
| Death | From the date of enrolment through study completion, minimum follow-up 2 years. | — |
| Major Bleeding | 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 | From the date of enrolment through study completion, minimum follow-up 2 years. | 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. |
| Myocardial Infarction | From the date of enrolment through study completion, minimum follow-up 2 years. | — |
Countries
Sweden
Outcome results
None listed