NCT03753490

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,933

participants targeted

Target at P75+ for not_applicable atrial-fibrillation

Timeline
25mo left

Started Oct 2018

Longer than P75 for not_applicable atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress78%
Oct 2018May 2028

Study Start

First participant enrolled

October 25, 2018

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

November 8, 2018

Completed
19 days until next milestone

First Posted

Study publicly available on registry

November 27, 2018

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2025

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2028

Expected
Last Updated

September 3, 2025

Status Verified

August 1, 2025

Enrollment Period

6.6 years

First QC Date

November 8, 2018

Last Update Submit

August 26, 2025

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • Composite of Stroke or Death

    From the date of enrolment through study completion, minimum follow-up 2 years.

Secondary Outcomes (6)

  • Major Bleeding

    From the date of enrolment through study completion, minimum follow-up 2 years.

  • 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.

  • 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.

  • +1 more secondary outcomes

Study Arms (2)

ABC score guided therapy

OTHER

Individual treatment recommendations based on the ABC-scores for stroke and bleeding.

Other: ABC score guided therapy

Standard care

OTHER

Management according to local practice, national and international guidelines.

Other: Standard care

Interventions

ABC score guided therapyOTHER

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.

ABC score guided therapy
Standard careOTHER

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.

Standard care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uppsala University Hospital

Uppsala, Sweden

Location

Related Publications (1)

  • Oldgren J, Hijazi Z, Arheden H, Bjorkenheim A, Frykman V, Janzon M, Ravn-Fischer A, Renlund H, Sjalander A, Akerfeldt T, Wallentin L. Biomarker-Based ABC-AF Risk Scores for Personalized Treatment to Reduce Stroke or Death in Atrial Fibrillation: A Registry-Based, Multicenter, Randomized, Controlled Study. Circulation. 2025 Nov 25;152(21):1457-1469. doi: 10.1161/CIRCULATIONAHA.125.076725. Epub 2025 Aug 30.

    PMID: 40884774DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Jonas Oldgren, MD, PhD

    Uppsala Clinical Reseach Center, UCR

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2018

First Posted

November 27, 2018

Study Start

October 25, 2018

Primary Completion

May 31, 2025

Study Completion (Estimated)

May 31, 2028

Last Updated

September 3, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)