Atrial Fibrillation (AF)SAFER-DOACNCT07713537
Risk Score of Embolism in Patients With AF Undergoing DOAC Therapy
An observational study of Atrial Fibrillation (AF) and Ischemic Stroke, run by Hospital Universitari Vall d'Hebron Research Institute at 2 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation (AF), Ischemic Stroke
- What is being tested?
- DOAC Level
- Type of treatment
- Pill or oral medicine
- How many people
- 250 participants
- Where
- 2 sitesSpain
- Study dates
- 1 Jan 2025to 31 Dec 2027
- How long will I take part?
- 3 Months
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients with a history of AF and on DOAC therapy.
Who may be able to join
- Patient over 18 years of age
- History of AD
- Currently on DOACs.
- Capacity to understand the study procedures and provide informed consent.
Who cannot join
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain2 sites, 2 recruiting
- Recruiting
Germans Trias University Hospital
Barcelona, Barcelona
Jesus Juega, MD, PhD., 934651200, jjuegam.germanstrias@gencat.cat
- Recruiting
Vall d'Hebron University Hospital
Barcelona, Barcelona
Jorge Pagola Perez, MD, PhD., 932746000 ext. 6364, jorge.pagola@vallhebron.cat
Claudia Meza Burgos, Msc., 932746000 ext. 6364, claudia.meza@vhir.org
About this study
Official title: 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.
- Conditions
- Atrial Fibrillation (AF), Ischemic Stroke
- Being tested
- DOAC Level
- Medical subject headings
- Atrial Fibrillation, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DOAC LevelOther
Testing for plasma DOAC level concentration to determine 'on-therapy' status
| Study group | Role | What they receive |
|---|---|---|
| Primary Prevention Cohort | Consecutive inclusion of patients undergoing DOAC therapy Receives: Other: DOAC Level | |
| Secondary Prevention Cohort | Consecutive inclusion of patients with AF who experience ischemic stroke despite direct oral anticoagulant DOACs. Receives: Other: DOAC Level |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From January 2023 to December 2027
Secondary outcomes (4)
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From January 2023 to December 2027
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start1 Jan 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07713537
- Sponsor's protocol ID
- PI24/00333
- Other IDs
- PI24/00333
- Acronym
- SAFER-DOAC
- Status last verified
- Jul 2026
- First submitted
- 12 Jan 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Due to a combination of participant privacy concerns.