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New treatment option for Embolic Stroke of Undetermined Source
Official title EMPA-ESUS. a Randomised Control Trial to Investigate the Impact of Empagliflozin on Left Atrial Function in Patients with Embolic Stroke of Undetermined Source
ClinicalTrials.gov ID: NCT06715449
What this study is testing
What is Empagliflozin 10 MG?
Empagliflozin 10 MG is an investigational medicine, given as an once-daily treatment applied to the skin, being studied as a potential treatment for embolic stroke of undetermined source.
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
- Atrial fibrillation (AF) is the most common heart rhythm problem in the adult population. There is a five-fold increase in stroke risk in patients with AF.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age over 18 years
- Patient has had an embolic stroke of undetermined source, defined as:
- Ischaemic stroke or transient ischaemic attack diagnosed clinically + supporting radiological features on CT or MRI imaging
- No clinically significant extracranial or intracranial atherosclerosis found on neck imaging
- No evidence of prevalent cardioembolic source of embolism - atrial dysrhythmia, cardiac thrombus, prosthetic valve, cardiac tumours, mitral stenosis...
You likely can't join if
- Prevalent atrial fibrillation or atrial flutter
- Subsequent demonstration of a cardio-emoblic source
- Pre-existent indication for SGLT2i including heart failure with a reduced ejection fraction and Type 1 or Type 2 diabetes mellitus
- Contraindication to the commencement of SGLT2i including a history of, or risk factors for diabetic ketoacidosis, such as restricted food intake or a...
- Hypersensitivity to the active substance or to any of the excipients of empagliflozin
- Presence of alternate implantable cardiac devices such as a pacemaker or defibrillator, that would make ILR utilisation redundant
See the full eligibility criteria
- Age over 18 years
- Patient has had an embolic stroke of undetermined source, defined as:
- Ischaemic stroke or transient ischaemic attack diagnosed clinically + supporting radiological features on CT or MRI imaging
- No clinically significant extracranial or intracranial atherosclerosis found on neck imaging
- No evidence of prevalent cardioembolic source of embolism - atrial dysrhythmia, cardiac thrombus, prosthetic valve, cardiac tumours, mitral stenosis, recent MI, LVEF\<35%, valvular vegetations, or infective endocarditis...
- No other specific stroke aetiology identified (pro-thrombotic states, arteritis, dissection, drug abuse)
- Patient has been referred for an implantable loop recorder implant to investigate possible atrial dysrhythmia
- Ability to give written, informed consent
- Prevalent atrial fibrillation or atrial flutter
- Subsequent demonstration of a cardio-emoblic source
- Pre-existent indication for SGLT2i including heart failure with a reduced ejection fraction and Type 1 or Type 2 diabetes mellitus
- Contraindication to the commencement of SGLT2i including a history of, or risk factors for diabetic ketoacidosis, such as restricted food intake or a history of alcohol abuse
- Hypersensitivity to the active substance or to any of the excipients of empagliflozin
- Presence of alternate implantable cardiac devices such as a pacemaker or defibrillator, that would make ILR utilisation redundant
- Any condition that may confound the results or interfere with participation such as dementia
- An unwillingness to participate
The study team makes the final eligibility decision.
Where it's taking place
- Cambridge, Cambridgeshire, United Kingdom
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cambridge, Cambridgeshire, United Kingdom. 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.