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

Phase

N/A

Condition

Chest Pain

Arrhythmia

Atrial Fibrillation

Treatment

ABC score guided therapy

Standard care

Clinical Study ID

NCT03753490

1011455

Ages > 18
All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion criteria:

Patients with diagnosis of atrial fibrillation, including newly diagnosed, with orwithout current oral anticoagulant treatment
Signed informed consent

Exclusion

Exclusion criteria:

Contraindication for any oral anticoagulant, according to the SmPC (in Sweden FASS)
Indication for oral anticoagulant treatment beyond atrial fibrillation, e.g. venousthromboembolism and/or mechanical heart valve prosthesis
Currently on treatment with a non-vitamin K antagonist oral anticoagulant (NOAC) andnot 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 therequirements of the protocol

Study Design