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NCT03753490Active, not recruiting

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

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

Source: ClinicalTrials.gov · Last updated 3 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
3933 (estimated)
First submitted
8 Nov 2018
Start date
25 Oct 2018
Primary completion date
31 May 2025
Lead sponsor
Uppsala University
NCT number
NCT03753490

What you commit to

  • Study type: Interventional
  • Planned participants: 3933
  • From 25 Oct 2018 to the primary completion date, 31 May 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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
  • Planned for AF ablation or AF surgery

Other illness

  • Indication for oral anticoagulant treatment beyond atrial fibrillation, e.g. venous thromboembolism and/or mechanical heart valve prosthesis
  • Acute coronary syndrome (myocardial infarction or unstable angina) within the last 30 days

Lab values

  • Haemoglobin \<90 g/L

Other

  • Contraindication for any oral anticoagulant, according to the SmPC (in Sweden FASS)
  • Participation in anti-thrombotic pharmaceutical trial
  • Patients who, in the opinion of the investigator, cannot or will not comply with the requirements of the protocol

Who the study is looking for

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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Uppsala University Hospital
Coordinator of this site? Confirm its status
UppsalaSwedenUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.