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Active Not RecruitingNCT03753490

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

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

Status
Active Not Recruiting
Phase
N/A
Study type
Interventional
Enrollment
3,933 (estimated)
Sponsor
Uppsala University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

TypeNameDescription
OTHERABC score guided therapyIn 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.
OTHERStandard careIn 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.

Timeline

Start date
2018-10-25
Primary completion
2025-05-31
Completion
2028-05-31
First posted
2018-11-27
Last updated
2025-09-03

Locations

1 site across 1 country: Sweden

Source: ClinicalTrials.gov record NCT03753490. Inclusion in this directory is not an endorsement.