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

June 20, 2023 updated by: Uppsala University

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

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Interventional

Enrollment (Estimated)

3933

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Uppsala, Sweden
        • Uppsala University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

  1. Patients with diagnosis of atrial fibrillation, including newly diagnosed, with or without current oral anticoagulant treatment
  2. Signed informed consent

Exclusion criteria:

  1. Contraindication for any oral anticoagulant, according to the SmPC (in Sweden FASS)
  2. Indication for oral anticoagulant treatment beyond atrial fibrillation, e.g. venous thromboembolism and/or mechanical heart valve prosthesis
  3. 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
  4. Concomitant dual antiplatelet treatment
  5. Acute coronary syndrome (myocardial infarction or unstable angina) within the last 30 days
  6. Participation in anti-thrombotic pharmaceutical trial
  7. Planned for AF ablation or AF surgery
  8. Haemoglobin <90 g/L
  9. Patients who, in the opinion of the investigator, cannot or will not comply with the requirements of the protocol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: ABC score guided therapy
Individual treatment recommendations based on the ABC-scores for stroke and bleeding.
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
Management according to local practice, national and international guidelines.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Composite of Stroke or Death
Time Frame: From the date of enrolment through study completion, minimum follow-up 2 years.
From the date of enrolment through study completion, minimum follow-up 2 years.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major Bleeding
Time Frame: From the date of enrolment through study completion, minimum follow-up 2 years.
From the date of enrolment through study completion, minimum follow-up 2 years.
Stroke
Time Frame: From the date of enrolment through study completion, minimum follow-up 2 years.
From the date of enrolment through study completion, minimum follow-up 2 years.
Death
Time Frame: From the date of enrolment through study completion, minimum follow-up 2 years.
From the date of enrolment through study completion, minimum follow-up 2 years.
Myocardial Infarction
Time Frame: From the date of enrolment through study completion, minimum follow-up 2 years.
From the date of enrolment through study completion, minimum follow-up 2 years.
Heart Failure
Time Frame: From the date of enrolment through study completion, minimum follow-up 2 years.
From the date of enrolment through study completion, minimum follow-up 2 years.
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.
From the date of enrolment through study completion, minimum follow-up 2 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Jonas Oldgren, MD, PhD, Uppsala Clinical Reseach Center, UCR

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 25, 2018

Primary Completion (Estimated)

May 31, 2025

Study Completion (Estimated)

May 31, 2025

Study Registration Dates

First Submitted

November 8, 2018

First Submitted That Met QC Criteria

November 21, 2018

First Posted (Actual)

November 27, 2018

Study Record Updates

Last Update Posted (Actual)

June 22, 2023

Last Update Submitted That Met QC Criteria

June 20, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 1011455

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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