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Prevention study for Stroke
Official title Stroke Prevention In Ischemic Stroke With Covert Atrial Fibrillation
ClinicalTrials.gov ID: NCT06486792
What this study is testing
What is Apixaban?
Apixaban is an investigational medicine, being studied as a potential treatment for stroke.
Also referred to as AVK, rivaroxaban.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 65 and older
You may be able to join if
- 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...
You likely can't join if
- 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
See the full eligibility criteria
- 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:
- 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...
- 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 \ 400 pg/mL or left ventricular ejection fraction (LVEF) \< 40% or supraventricular...
- 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.
- 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
- Participation in another treatment clinical trial.
- Under contraception in case of childbearing potential
- Patient under guardianship or curatorship
The study team makes the final eligibility decision.
Where it's taking place
- Paris, Paris, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Paris, Paris, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.