Risk Score of Embolism in Patients With AF Undergoing DOAC Therapy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorHospital Universitari Vall d'Hebron Research Institute
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Patient over 18 years of age
History of AD
Currently on DOACs.
Capacity to understand the study procedures and provide informed consent.
Disqualifiers
Patient with valvular AF (mitral stenosis) or mechanical valve prostheses.
Unable to complete a follow-up period of at least 3 months from enrollment.
Trial population
Patients with a history of AF and on DOAC therapy.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
DOAC Level
Other interventionTesting for plasma DOAC level concentration to determine 'on-therapy' status
Treatment groups
250 Participants
are divided into 2 treatment groupsGroup A: Primary Prevention Cohort1 intervention
Group B: Secondary Prevention Cohort1 intervention
Trial outcomes
Primary outcomes
1
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 2027Secondary outcomes
1
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 20272
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 20273
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 study4
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 2027Sponsors and contacts
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Source ClinicalTrials.gov