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
- Are there results?
- Not yet: the study is under way
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.
- More trials run by Hospital Universitari Vall d'Hebron Research InstituteThe sponsor's other registered studies.
- 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
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Score of Embolism in Patients With Atrial Fibrillation (AF) Undergoing Treatment With Direct Oral Anticoagulant (DOAC)
- ClinicalTrials.gov ID
- NCT07713537
- Acronym / sponsor ID
- SAFER-DOAC / PI24/00333
- Conditions
- Atrial Fibrillation (AF), Ischemic Stroke
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 20 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primary Prevention Cohort | – | Other: DOAC LevelConsecutive inclusion of patients undergoing DOAC therapy |
| Secondary Prevention Cohort | – | Other: DOAC LevelConsecutive inclusion of patients with AF who experience ischemic stroke despite direct oral anticoagulant DOACs. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with a history of AF and on DOAC therapy.
Key inclusion criteria (4 listed)
- Patient over 18 years of age
- History of AD
- Currently on DOACs.
- Capacity to understand the study procedures and provide informed consent.
Key exclusion criteria (2 listed)
- Patient with valvular AF (mitral stenosis) or mechanical valve prostheses.
- Unable to complete a follow-up period of at least 3 months from enrollment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DOAC LevelTesting for plasma DOAC level concentration to determine 'on-therapy' status | Other | Primary Prevention Cohort, Secondary Prevention Cohort |
Primary outcome
Stroke Risk Scale
Time frame: From January 2023 to December 2027
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.
4 secondary outcomes
Plasma DOACs level
Time frame: From January 2023 to December 2027
Burden of atrial disease
Time frame: From January 2023 to December 2027
Large Intracranial Vessel Occlusion (LVO)
Time frame: Until the end of the study
Adherence to DOAC treatment
Time frame: From January 2023 to December 2027
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Individual participant dataSharing planned: Undecided. Due to a combination of participant privacy concerns.
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ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION, Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation (AF) and Ischemic Stroke, run by Hospital Universitari Vall d'Hebron Research Institute at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stroke Risk Scale (time frame: From January 2023 to December 2027). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.