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Recruiting NCT07713537

Risk Score of Embolism in Patients With AF Undergoing DOAC Therapy

— Observational Atrial Fibrillation (AF) Ischemic Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: DOAC Level.
Who it may be relevant to
Registry conditions: Atrial Fibrillation (AF), Ischemic Stroke. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • Stroke Risk Scale [Time frame: From January 2023 to December 2027]
Secondary outcome measures (4)
  • Plasma DOACs level [Time frame: From January 2023 to December 2027]
  • Burden of atrial disease [Time frame: From January 2023 to December 2027]
  • Large Intracranial Vessel Occlusion (LVO) [Time frame: Until the end of the study]
  • Adherence to DOAC treatment [Time frame: From January 2023 to December 2027]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Spain · 2 centers
  • Germans Trias University Hospital — Barcelona
  • Vall d'Hebron University Hospital — Barcelona

Identifiers

NCT: NCT07713537 · PI24/00333 · PI24/00333

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗