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NCT Number: NCT07713537

Risk Score of Embolism in Patients With AF Undergoing DOAC Therapy

Acute ischaemic strokes occur despite the use of direct oral anticoagulants (DOACs). Evidence-based scale is necessary to assess ischemic stroke risk in atrial fibrillation (AF) patients.

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Key information

Conditions

Atrial Fibrillation (AF) Arrhythmias, Cardiac Atrial Fibrillation Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Heart Diseases Ischemic Stroke Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Germans Trias University Hospital, Barcelona, Spain

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient over 18 years of age
  • History of AD
  • Currently on DOACs.
  • Capacity to understand the study procedures and provide informed consent.

Exclusion criteria

  • Patient with valvular AF (mitral stenosis) or mechanical valve prostheses.
  • Unable to complete a follow-up period of at least 3 months from enrollment.

Treatment and study plan

DOAC Level

Other

Testing for plasma DOAC level concentration to determine 'on-therapy' status

Primary outcomes

  1. Stroke Risk Scale

    Time frame: From January 2023 to December 2027

    To design and validate a stroke risk scale specific to AF patients undergoing DOAC therapy (target patients), through retrospective analysis of a population sample, based on demographic, clinical, socioeconomic and gender factors; as well as other newly identified factors.

Secondary outcomes

  1. Plasma DOACs level

    Time frame: From January 2023 to December 2027

    To determine plasma levels of DOACs in two prospective cohorts of target patients who have or have not had a stroke to assess stroke risk scale

  2. Burden of atrial disease

    Time frame: From January 2023 to December 2027

    Analyze the burden of atrial disease (AF burden on Holter and atrial size) in each of the prospective cohorts.

  3. Large Intracranial Vessel Occlusion (LVO)

    Time frame: Until the end of the study

    To quantify the proportion of thrombotic events evidenced as large intracranial vessel occlusion or intracardiac thrombus in the prospective cohort of AF patients treated with DOACs who present with a stroke.

  4. Adherence to DOAC treatment

    Time frame: From January 2023 to December 2027

    To evaluate the impact of a clinical intervention of education on disease and treatment on adherence to DOAC treatment, as determined by a medication adherence scale and plasma levels of DOAC at 3 months from baseline determination in each of the prospective cohort.

Sponsors and collaborators

Lead sponsor

Hospital Universitari Vall d'Hebron Research Institute

Other

Registry information

Official study title

Risk Score of Embolism in Patients With Atrial Fibrillation (AF) Undergoing Treatment With Direct Oral Anticoagulant (DOAC)

Acronym: SAFER-DOAC

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 20, 2026
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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