Risk Score of Embolism in Patients With AF Undergoing DOAC Therapy

Hospital Universitari Vall d'Hebron Research Institute250 enrolled

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.

Study Type

OBSERVATIONAL

Enrollment

250

Conditions

Atrial Fibrillation (AF)Ischemic Stroke

Interventions

DOAC LevelOTHER

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

Eligibility

Sex: ALLHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (2)

Germans Trias University Hospital

Barcelona, Barcelona, Spain

RECRUITING

Vall d'Hebron University Hospital

Barcelona, Barcelona, Spain

RECRUITING

Outcomes

Primary Outcomes

Stroke Risk Scale

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.

Time frame: From January 2023 to December 2027

Secondary Outcomes

Plasma DOACs level

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

Time frame: From January 2023 to December 2027

Burden of atrial disease

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

Time frame: From January 2023 to December 2027

Large Intracranial Vessel Occlusion (LVO)

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.

Time frame: Until the end of the study

Adherence to DOAC treatment

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.

Time frame: From January 2023 to December 2027

Data from ClinicalTrials.gov

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