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

NCT03753490 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3933

Last updated 2025-09-03

No results posted yet for this 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.

Conditions

Interventions

OTHER

ABC score guided therapy

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.

OTHER

Standard care

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.

Sponsors & Collaborators

  • Swedish Foundation for Strategic Research

    collaborator OTHER

  • Swedish Heart Lung Foundation

    collaborator OTHER

  • Roche Diagnostics GmbH

    collaborator INDUSTRY

  • The Swedish Research Council

    collaborator OTHER_GOV

  • Uppsala University

    lead OTHER

Principal Investigators

  • Jonas Oldgren, MD, PhD · Uppsala Clinical Reseach Center, UCR

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-25
Primary Completion
2025-05-31
Completion
2028-05-31

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03753490 on ClinicalTrials.gov