NCT07713537

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
17mo left

Started Jan 2025

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress53%
Jan 2025Dec 2027

Study Start

First participant enrolled

January 1, 2025

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 12, 2026

Completed
6 months until next milestone

First Posted

Study publicly available on registry

July 20, 2026

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

July 20, 2026

Status Verified

July 1, 2026

Enrollment Period

3 years

First QC Date

January 12, 2026

Last Update Submit

July 17, 2026

Conditions

Atrial Fibrillation (AF)Ischemic Stroke

Outcome Measures

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.

    From January 2023 to December 2027

Secondary Outcomes (4)

  • Plasma DOACs level

    From January 2023 to December 2027

  • Burden of atrial disease

    From January 2023 to December 2027

  • Large Intracranial Vessel Occlusion (LVO)

    Until the end of the study

  • Adherence to DOAC treatment

    From January 2023 to December 2027

Study Arms (2)

Primary Prevention Cohort

Consecutive inclusion of patients undergoing DOAC therapy

Other: DOAC Level

Secondary Prevention Cohort

Consecutive inclusion of patients with AF who experience ischemic stroke despite direct oral anticoagulant DOACs.

Other: DOAC Level

Interventions

DOAC LevelOTHER

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

Primary Prevention CohortSecondary Prevention Cohort

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with a history of AF and on DOAC therapy.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Germans Trias University Hospital

Barcelona, Barcelona, Spain

RECRUITING

Vall d'Hebron University Hospital

Barcelona, Barcelona, Spain

RECRUITING

MeSH Terms

Conditions

Atrial FibrillationIschemic Stroke

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsStrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2026

First Posted

July 20, 2026

Study Start

January 1, 2025

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

July 20, 2026

Record last verified: 2026-07

Locations

ES(2)