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

Uppsala University

Status: Active, not recruiting

Conditions: Atrial Fibrillation

Treatments: Other: Standard care; Other: ABC score guided therapy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03753490

1011455

Details and patient eligibility

About

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.

Enrollment: 3,933 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3,933 participants in 2 patient groups

ABC score guided therapy

Other group

Description:

Individual treatment recommendations based on the ABC-scores for stroke and bleeding.

Treatment:

Other: ABC score guided therapy

Standard care

Other group

Description:

Management according to local practice, national and international guidelines.

Treatment:

Other: Standard care