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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

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

Primary outcome measure(s)

• Composite of Stroke or Death — From the date of enrolment through study completion, minimum follow-up 2 years.

Trial sites (1)

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