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

Not Applicable

Active, not recruiting

• Conditions: Atrial Fibrillation
• Interventions: Other: ABC score guided therapy; Other: Standard care

• Registration Number: NCT03753490
• Lead Sponsor: Uppsala University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-11-08
• Study First Submitted QC: 2018-11-21
• Study Start: 2018-11-25
• Study First Posted: 2018-11-27
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-20
• Last Update Posted: 2023-06-22
• Primary Completion: 2025-05-31
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 3933

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ABC score guided therapy	ABC score guided therapy	Individual treatment recommendations based on the ABC-scores for stroke and bleeding.
Standard care	Standard care	Management according to local practice, national and international guidelines.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Stroke	From the date of enrolment through study completion, minimum follow-up 2 years.
Death	From the date of enrolment through study completion, minimum follow-up 2 years.
Major Bleeding	From the date of enrolment through study completion, minimum follow-up 2 years.
Myocardial Infarction	From the date of enrolment through study completion, minimum follow-up 2 years.
Heart Failure	From the date of enrolment through study completion, minimum follow-up 2 years.
Health Economics	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.

Trial Locations

Locations (1)

Uppsala University Hospital; 🇸🇪 Uppsala, Sweden