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NCT Number: NCT03753490

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Uppsala University Hospital

Uppsala, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ABC score guided therapy

Other

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 care

Other

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.

Primary outcomes

  1. Composite of Stroke or Death

    Time frame: From the date of enrolment through study completion, minimum follow-up 2 years.

Secondary outcomes

  1. Major Bleeding

    Time frame: From the date of enrolment through study completion, minimum follow-up 2 years.

  2. Stroke

    Time frame: From the date of enrolment through study completion, minimum follow-up 2 years.

  3. Death

    Time frame: From the date of enrolment through study completion, minimum follow-up 2 years.

  4. Myocardial Infarction

    Time frame: From the date of enrolment through study completion, minimum follow-up 2 years.

  5. Heart Failure

    Time frame: From the date of enrolment through study completion, minimum follow-up 2 years.

  6. Health Economics

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Collaborators

  • Roche Diagnostics GmbH
  • Swedish Foundation for Strategic Research
  • Swedish Heart Lung Foundation
  • The Swedish Research Council

Registry information

Official study title

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

Acronym: ABC-AF

Important dates

Study start
2018
Primary completion
2025
Study completion
2028
First posted
Nov 27, 2018
Registry last updated
Sep 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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