Clinical trial NCT03753490: ABC-Scores for Reduction of Stroke and Mortality in Atrial Fibrillation - The ABC-AF Study
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: Uppsala University
Sponsor class: OTHER
Collaborators: name: Swedish Foundation for Strategic Research
name: Swedish Heart Lung Foundation
name: Roche Diagnostics GmbH
name: The Swedish Research Council
First posted: 2018-11-27
Enrollment: 3933
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Composite of Stroke or Death
timeFrame: From the date of enrolment through study completion, minimum follow-up 2 years.
Secondary outcomes:
measure: Major Bleeding
timeFrame: From the date of enrolment through study completion, minimum follow-up 2 years.
measure: Stroke
timeFrame: From the date of enrolment through study completion, minimum follow-up 2 years.
measure: Death
timeFrame: From the date of enrolment through study completion, minimum follow-up 2 years.
measure: Myocardial Infarction
timeFrame: From the date of enrolment through study completion, minimum follow-up 2 years.
measure: Heart Failure
timeFrame: From the date of enrolment through study completion, minimum follow-up 2 years.
measure: Health Economics
timeFrame: From the date of enrolment through study completion, minimum follow-up 2 years.
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Uppsala University Hospital
Study officials:
affiliation: Uppsala Clinical Reseach Center, UCR
name: Jonas Oldgren, MD, PhD
role: STUDY_DIRECTOR
References: