Risk Score of Embolism in Patients With AF Undergoing DOAC Therapy (SAFER-DOAC)

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

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 Overview

• Status: Recruiting
• Conditions: Ischemic Stroke; Atrial Fibrillation (AF)
• Intervention / Treatment: Other: DOAC Level

• Study Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Barcelona, Barcelona, Spain
      • Recruiting
      • Germans Trias University Hospital
      • Contact: Jesus Juega, MD, PhD.; Phone Number: 934651200; Email: jjuegam.germanstrias@gencat.cat
    • Barcelona, Barcelona, Spain
      • Recruiting
      • Vall d'Hebron University Hospital
      • Contact: Jorge Pagola Perez, MD, PhD.; Phone Number: 6364 932746000; Email: jorge.pagola@vallhebron.cat
      • Contact: Claudia Meza Burgos, Msc.; Phone Number: 6364 932746000; Email: claudia.meza@vhir.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients with a history of AF and on DOAC therapy.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Primary Prevention Cohort; Consecutive inclusion of patients undergoing DOAC therapy	Other: DOAC Level; Testing for plasma DOAC level concentration to determine 'on-therapy' status
Secondary Prevention Cohort; Consecutive inclusion of patients with AF who experience ischemic stroke despite direct oral anticoagulant DOACs.	Other: DOAC Level; Testing for plasma DOAC level concentration to determine 'on-therapy' status

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From January 2023 to December 2027

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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.	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.	From January 2023 to December 2027

Collaborators and Investigators

• Sponsor: Hospital Universitari Vall d'Hebron Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: January 12, 2026
• First Submitted That Met QC Criteria: July 17, 2026
• First Posted (Actual): July 20, 2026

Study Record Updates

• Last Update Posted (Actual): July 20, 2026
• Last Update Submitted That Met QC Criteria: July 17, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Stroke; Pathological Conditions, Signs and Symptoms; Ischemic Stroke; Atrial Fibrillation
• Other Study ID Numbers: PI24/00333 (Other Identifier: ISCIII)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Due to a combination of participant privacy concerns.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No