StrokePhase 4SPICAFNCT06486792
Stroke Prevention In Ischemic Stroke With Covert Atrial Fibrillation
A Phase 4 study testing Apixaban and Aspirin in people with Stroke and Ischemic Stroke, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Patients who have recently had an ischemic stroke with no clear cause might have undetected atrial fibrillation (AF) that isn't caught during their initial hospital stay. After discharge, these patients are typically monitored for AF using devices like Holter monitors or implantable loop recorders. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Stroke, Ischemic Stroke, Cerebral Infarction
- What is being tested?
- Apixaban and Aspirin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,148 participants
- Where
- 1 siteFrance
- Study dates
- 18 Jun 2025to 18 Dec 2028
- Phase
- Phase 4
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Included patients must fulfill the following 4 criteria:
- patient aged ≥65 years with:
- recent (<15 days) cerebral infarction
- with cerebral ischemia proven on MRI or head-CT
- with no known atrial fibrillation before stroke and no atrial fibrillation detected during hospital stay (monitoring or telemetry) and no mural thrombus.
- but with suspected atrial fibrillation:
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- multiple territorial (i.e., in the territory of a cerebral artery or one of its branches) cerebral infarctions in several arterial territories involving both hemispheres, or in the same hemisphere, or in both anterior and posterior circulation, symptomatic or not
- or a single cerebral infarction and systemic emboli (e.g., renal, splenic, hepatic or mesenteric infarction, peripheral emboli in arm or leg), symptomatic or not
- or any ischemic stroke with dilation of atrium (>34 mL/m²) or left atrial spontaneous echocardiographic contrast or LAA velocities < 40 cm/sec or pro BNP > 400 pg/mL or left ventricular ejection fraction (LVEF) < 40% or supraventricular extrasystole ≥ 400/24 h or longest "atrial run" ≥ 20 beats on telemetry
- or age ≥80 year-old and a single infarction
- and a plan to detect atrial fibrillation with, long term Holter ECG, wearing device or implantable loop recorder
- with a Rankin score equal or less than 4
- patient has signed an informed consent
- Patient is affiliated to a social security.
Who cannot join
- Patients with a known cause of stroke, using ASCOD classification A1, C1, S1, O1, D1
- Symptomatic brain hemorrhage (the mere presence of microbleeds on gradient echo imaging is not an exclusion criteria)
- Uncontrolled hypertension (following the judgment of the investigator)
- Clear indication to anticoagulant or antiplatelet therapy
- Contra-indication to anticoagulant or antiplatelet therapy
- Intercurrent disease that may interfere with evaluation of the primary end-point or that may prevent follow-up study visits
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- Participation in another interventional clinical trial.
- Under contraception in case of childbearing potential
- Patient under guardianship or curatorship
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Bichat Hospital
Paris, Paris, 75018
Philippa LAVALLEE, philippa.lavallee@aphp.fr
About this study
Patients who have recently had an ischemic stroke with no clear cause might have undetected atrial fibrillation (AF) that isn't caught during their initial hospital stay. After discharge, these patients are typically monitored for AF using devices like Holter monitors or implantable loop recorders. Treatment options during this period include anticoagulants or aspirin. Anticoagulants are more effective in preventing recurrent strokes if AF is present, offering an 80% risk reduction compared to aspirin's 20%. If AF is detected, anticoagulant treatment continues; if not, patients may switch to aspirin after 6-12 months. Despite the clinical rationale for using anticoagulants during this search period, their benefit-risk ratio compared to aspirin has not been fully evaluated.
Read the detailed description
Patients with recent ischemic stroke with an unknown cause may have a clinical, radiological and echocardiographic pattern of covert atrial fibrillation which is yet undetected by history, ECG monitoring or telemetry during the initial hospital stay. These patients are usually discharged with a prescription of detection of atrial fibrillation in the next weeks by either Holter ECG monitoring, or loop recorder such as wearing device or implantable device. Current standard treatment for these patients is either using anticoagulant treatment during the time of atrial fibrillation search or simply aspirin with the risk that the patient has an undetected paroxysmal atrial fibrillation with a high risk of recurrent stroke that is less prevented by aspirin (20% RRR) than by anticoagulant (80% RRR). Anticoagulant treatment in this situation is clinically justified by the fact that if the patient actually has an atrial fibrillation, an anticoagulant treatment during the search period of AF will protect the patient from a recurrent stroke, rather than treating the patient after the discovery of AF with the risk that an AF-related recurrent stroke occurs in-between. Anticoagulant treatment is then continued if atrial fibrillation is demonstrated by monitory devices, or is stopped with a switch to aspirin after 6-12 months of negative AF search, since investigators know, after NAVIGATE-ESUS and RESPECT-ESUS trials, that long-term aspirin is safer and as effective as anticoagulant in case of cryptogenic stroke.
Although anticoagulant treatment during the search period for AF makes clinically sense, and is widely used in clinical practice, its benefit/risk ratio compared to aspirin therapy has not been evaluated
- Conditions
- Stroke, Ischemic Stroke, Cerebral Infarction, Atrial Fibrillation
- Keywords
- Stroke, Ischemic Stroke, Cerebral infarction, Atrial Fibrillation, Anticoagulant, Aspirin, Prevention stroke, AVK, Apixaban, rivaroxaban, dabigatran, ECG
- Medical subject headings
- Stroke, Ischemic Stroke, Cerebral Infarction, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApixabanDrug
Also called AVK, rivaroxaban, dabigatran
Patients who have had an ischemic stroke will receive either an anticoagulant or aspirin according to their randomization arm.
AspirinDrug
Aspirin is used as the standard of care
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic anticoagulation | Experimental | Choice of the investigator, VKA with target INR 2-3, or apixaban, rivaroxaban or dabigatran) Receives: Drug: Apixaban |
| Aspirin 75-300 mg/day | Active comparator | Aspirin is the standard of care treatment. Receives: Drug: Aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of fatal or nonfatal ischemic stroke, or peripheral emboli (even if asymptomatic) [peripheral emboli: emboli in arm or leg, new renal, splenic, hepatic, mesenteric infarction]
Evaluate two commonly used antithrombotic treatment strategies in patients with recent ischemic stroke and at high risk of atrial fibrillation.
Measured: During the 12 month follow-up
Secondary outcomes (2)
Sensitivity (percentage of true positives) in detecting AF
Yield and comparative rates of atrial fibrillation discovered using various tools (Holter-ECG monitoring device, loop recorder (wearing or implantable monitoring device).
Measured: long term using various tools (3 weeks)
The Occurrence of: Recurrent fatal or nonfatal ischemic stroke, any stroke, any stroke or TIA or vascular death
Evaluate two commonly used antithrombotic treatment strategies in patients with recent ischemic stroke and at high risk of atrial fibrillation.
Measured: During the 12 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start18 Jun 2025
- Primary completion18 Dec 2028 (estimated)
- Study completion18 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial, open-labelled, of two standard of care therapeutic strategies: therapeutic anticoagulation (choice of the investigator, VKA with target INR 2-3, or apixaban, rivaroxaban or dabigatran) vs aspirin 75-300 mg/day
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06486792
- Sponsor's protocol ID
- APHP230839
- Acronym
- SPICAF
- Status last verified
- Jul 2025
- First submitted
- 14 Jun 2024
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stroke Prevention In Ischemic Stroke With Covert Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT06486792
- Acronym / sponsor ID
- SPICAF / APHP230839
- Conditions
- Stroke, Ischemic Stroke, Cerebral Infarction, Atrial Fibrillation
- Keywords
- Stroke, Ischemic Stroke, Cerebral infarction, Atrial Fibrillation, Anticoagulant, Aspirin, Prevention stroke, AVK
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,148 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 18 Jun 2025 (actual)
- Primary completion
- 18 Dec 2028 (estimated)
- Study completion
- 18 Dec 2028 (estimated)
- First posted
- 5 Jul 2024 (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.
Patients who have recently had an ischemic stroke with no clear cause might have undetected atrial fibrillation (AF) that isn't caught during their initial hospital stay. After discharge, these patients are typically monitored for AF using devices like Holter monitors or implantable loop recorders. Treatment options during this period include anticoagulants or aspirin. Anticoagulants are more effective in preventing recurrent strokes if AF is present, offering an 80% risk reduction compared to aspirin's 20%. If AF is detected, anticoagulant treatment continues; if not, patients may switch to aspirin after 6-12 months. Despite the clinical rationale for using anticoagulants during this search period, their benefit-risk ratio compared to aspirin has not been fully evaluated.
Detailed description
Patients with recent ischemic stroke with an unknown cause may have a clinical, radiological and echocardiographic pattern of covert atrial fibrillation which is yet undetected by history, ECG monitoring or telemetry during the initial hospital stay. These patients are usually discharged with a prescription of detection of atrial fibrillation in the next weeks by either Holter ECG monitoring, or loop recorder such as wearing device or implantable device. Current standard treatment for these patients is either using anticoagulant treatment during the time of atrial fibrillation search or simply aspirin with the risk that the patient has an undetected paroxysmal atrial fibrillation with a high risk of recurrent stroke that is less prevented by aspirin (20% RRR) than by anticoagulant (80% RRR). Anticoagulant treatment in this situation is clinically justified by the fact that if the patient actually has an atrial fibrillation, an anticoagulant treatment during the search period of AF will protect the patient from a recurrent stroke, rather than treating the patient after the discovery of AF with the risk that an AF-related recurrent stroke occurs in-between. Anticoagulant treatment is then continued if atrial fibrillation is demonstrated by monitory devices, or is stopped with a switch to aspirin after 6-12 months of negative AF search, since investigators know, after NAVIGATE-ESUS and RESPECT-ESUS trials, that long-term aspirin is safer and as effective as anticoagulant in case of cryptogenic stroke.
Although anticoagulant treatment during the search period for AF makes clinically sense, and is widely used in clinical practice, its benefit/risk ratio compared to aspirin therapy has not been evaluated
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial, open-labelled, of two standard of care therapeutic strategies: therapeutic anticoagulation (choice of the investigator, VKA with target INR 2-3, or apixaban, rivaroxaban or dabigatran) vs aspirin 75-300 mg/day
| Arm | Type | Receives |
|---|---|---|
| Therapeutic anticoagulation | Experimental | Drug: ApixabanChoice of the investigator, VKA with target INR 2-3, or apixaban, rivaroxaban or dabigatran) |
| Aspirin 75-300 mg/day | Active comparator | Drug: AspirinAspirin is the standard of care treatment. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (14 listed)
- patient aged ≥65 years with:
- with no known atrial fibrillation before stroke and no atrial fibrillation detected during hospital stay (monitoring or telemetry) and no mural thrombus.
- but with suspected atrial fibrillation:
- and a plan to detect atrial fibrillation with, long term Holter ECG, wearing device or implantable loop recorder
- with a Rankin score equal or less than 4
Key exclusion criteria (9 listed)
- Patients with a known cause of stroke, using ASCOD classification A1, C1, S1, O1, D1
- Symptomatic brain hemorrhage (the mere presence of microbleeds on gradient echo imaging is not an exclusion criteria)
- Uncontrolled hypertension (following the judgment of the investigator)
- Clear indication to anticoagulant or antiplatelet therapy
- Contra-indication to anticoagulant or antiplatelet therapy
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 |
|---|---|---|
| ApixabanAlso: AVK, rivaroxaban, dabigatranPatients who have had an ischemic stroke will receive either an anticoagulant or aspirin according to their randomization arm. | Drug | Therapeutic anticoagulation |
| AspirinAspirin is used as the standard of care | Drug | Aspirin 75-300 mg/day |
Primary outcome
Occurrence of fatal or nonfatal ischemic stroke, or peripheral emboli (even if asymptomatic) [peripheral emboli: emboli in arm or leg, new renal, splenic, hepatic, mesenteric infarction]
Time frame: During the 12 month follow-up
Evaluate two commonly used antithrombotic treatment strategies in patients with recent ischemic stroke and at high risk of atrial fibrillation.
2 secondary outcomes
Sensitivity (percentage of true positives) in detecting AF
Time frame: long term using various tools (3 weeks)
The Occurrence of: Recurrent fatal or nonfatal ischemic stroke, any stroke, any stroke or TIA or vascular death
Time frame: During the 12 month follow-up
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 5 Jun 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Apixaban and Aspirin in people with Stroke and Ischemic Stroke, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 14 inclusion and 9 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 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Philippa Lavallée, PhD (1 40 25 87 25 ext. +33, philippa.lavallee@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of fatal or nonfatal ischemic stroke, or peripheral emboli (even if asymptomatic) [peripheral emboli: emboli in arm or leg, new renal, splenic, hepatic, mesenteric infarction] (time frame: During the 12 month follow-up). 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 5 Jun 2026.