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

N/AActive Not RecruitingNCT03753490

Uppsala University3,933 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

3,933

Conditions

Atrial Fibrillation

Interventions

ABC score guided therapyOTHER

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.

Standard careOTHER

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Uppsala University Hospital

Uppsala, Sweden