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

  • STATUS
    Recruiting
  • End date
    Oct 31, 2024
  • participants needed
    6500
  • sponsor
    Uppsala University
Updated on 24 May 2022
stroke
anticoagulants
fibrillation
vitamin k

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.

Details
Condition Atrial Fibrillation
Treatment Standard Care, ABC score guided therapy
Clinical Study IdentifierNCT03753490
SponsorUppsala University
Last Modified on24 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
Participation in anti-thrombotic pharmaceutical trial
Acute coronary syndrome (myocardial infarction or unstable angina) within the last 30 days
Planned for AF ablation or AF surgery
Patients who, in the opinion of the investigator, cannot or will not comply with the requirements of the protocol
Haemoglobin <90 g/L
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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