ABC-Scores for Reduction of Stroke and Mortality in Atrial Fibrillation - The ABC-AF Study

Study Overview
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Brief Summary
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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.

Official Title
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ABC-Risk Scores for Reduction of Stroke and Mortality in Atrial Fibrillation - a Multicenter, Registry-based, Randomized Controlled Parallel-group Open-label Study

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Other: ABC score guided therapy
* Other: Standard care


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Patients with diagnosis of atrial fibrillation, including newly diagnosed, with or without current oral anticoagulant treatment Signed informed consent Exclusion criteria: 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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: ABC score guided therapy<br>Individual treatment recommendations based on the ABC-scores for stroke and bleeding. | Other: ABC score guided therapy<br>* 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.<br>|
| Other: Standard care<br>Management according to local practice, national and international guidelines. | Other: Standard care<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of Stroke or Death |  | From the date of enrolment through study completion, minimum follow-up 2 years. | 

Secondary Outcome Measures

| Outcome Measure | 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. | 
| 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. |