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

Atrial Fibrillation Clinical Trial

— ABC-AF  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03753490
• Other study ID #: 1011455
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 25, 2018
• Est. completion date: May 31, 2025

Study information

• Verified date: June 2023
• Source: Uppsala University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 3933
• Est. completion date: May 31, 2025
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Sweden	Uppsala University Hospital	Uppsala

Sponsors (5)

Lead Sponsor	Collaborator
Uppsala University	Roche Diagnostics, Swedish Foundation for Strategic Research, Swedish Heart Lung Foundation, The Swedish Research Council

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite of Stroke or Death		From the date of enrolment through study completion, minimum follow-up 2 years.
Secondary	Major Bleeding		From the date of enrolment through study completion, minimum follow-up 2 years.
Secondary	Stroke		From the date of enrolment through study completion, minimum follow-up 2 years.
Secondary	Death		From the date of enrolment through study completion, minimum follow-up 2 years.
Secondary	Myocardial Infarction		From the date of enrolment through study completion, minimum follow-up 2 years.
Secondary	Heart Failure		From the date of enrolment through study completion, minimum follow-up 2 years.
Secondary	Health Economics	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.