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New treatment option for Ischemic Stroke
Official title Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
ClinicalTrials.gov ID: NCT05976685
What this study is testing
What is DOAC?
DOAC is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for ischemic stroke.
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 one of the most common cardiac arrhythmias and cardioembolic stroke due to AF is its major complication. Direct oral anticoagulants (DOAC) reduce the risk of cardioembolism in patients with AF.
- 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 ≥ 18 years
- Written informed consent
- Permanent, persistent, or paroxysmal spontaneous AF previously known or diagnosed during the index hospitalization.
- Recent (≤3 months) symptomatic ischemic stroke.
- Active and ongoing anticoagulation therapy at stroke onset assessed based on medical history (i.e. any therapeutic oral anticoagulation therapy...
You likely can't join if
- Contraindications to DOAC therapy
- Life expectancy \<1 year according to the opinion of the investigator
- Stroke due to: Ipsilateral intra/extracranial high-grade stenosis, Isolated lacunar stroke, Other well-defined stroke aetiologies (i.e...
- Previous persistent foramen ovale or atrial septum defect closure.
- Rheumatic heart disease
- Severe heart valve disease that requires treatment (severe aortic stenosis or regurgitation, severe mitral stenosis or regurgitation).
See the full eligibility criteria
- Age ≥ 18 years
- Written informed consent
- Permanent, persistent, or paroxysmal spontaneous AF previously known or diagnosed during the index hospitalization.
- Recent (≤3 months) symptomatic ischemic stroke.
- Active and ongoing anticoagulation therapy at stroke onset assessed based on medical history (i.e. any therapeutic oral anticoagulation therapy [Vitamin K antagonist/DOAC according to prescription recommendations for...
- Active or planned long-term therapy with DOAC
- Contraindications to DOAC therapy
- Life expectancy \<1 year according to the opinion of the investigator
- Stroke due to: Ipsilateral intra/extracranial high-grade stenosis, Isolated lacunar stroke, Other well-defined stroke aetiologies (i.e., endocarditis, vasculitis, Reversible Cerebral Vasoconstriction Syndrome [RCVS]...
- Previous persistent foramen ovale or atrial septum defect closure.
- Rheumatic heart disease
- Severe heart valve disease that requires treatment (severe aortic stenosis or regurgitation, severe mitral stenosis or regurgitation).
- Contraindications for TEE (relevant esophageal varices, esophageal stricture, history of esophageal cancer).
- Cardiac or non-cardiac surgical procedure within 30 days of randomization
- Enrolled in another investigation of a cardiovascular device or investigating secondary prevention therapy.
- Severely reduced Left Ventricular Ejection Fraction (LVEF) \<30%.
- Severe renal impairment as described in the summary of medicinal product characteristics for the chosen DOAC (e.g. rivaroxaban, apixaban and edoxaban creatinine clearance \<15 ml/min; dabigatran creatinine clearance...
- Hypertrophic cardiomyopathy
- Intracardiac tumor
- Ventricular thrombus
- Acute cardiac decompensation
- LAA is obliterated or surgically ligated
- Persistent proximal LAA thrombus despite 4 weeks of anticoagulation (if a proximal thrombus in the LAA is found, anticoagulation with vitamin K antagonist (INR 2.5-3.5) may be started, and if the thrombus disappears...
- Pregnancy or breastfeeding (pregnancy test in urine or blood to be performed at screening for women of childbearing potential)
The study team makes the final eligibility decision.
Where it's taking place
- Brussels, Brussels Capital, Belgium
- Bruges, Belgium
- Brussels, Belgium
- Charleroi, Belgium
- Leuven, Belgium
- Liège, Belgium
- Hamburg, Free and Hanseatic City of Hamburg, Germany
- Leipzig, Leipzig, Germany
- Mannheim, Mannheim, Germany
- Lübeck, Schleswig-Holstein, Germany
- Berlin, State of Berlin, Germany
- Bonn, Germany
- Göttingen, Germany
- Heidelberg, Germany
- Tübingen, Germany
- Christchurch, Christchurch, New Zealand
- Barcelona, Spain
- Madrid, Spain
- Basel, Basel, Switzerland
- Bern, Canton of Bern, Switzerland
+ 7 more site(s).
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 Brussels, Brussels Capital, Belgium; Bruges, Belgium; Brussels, Belgium; Charleroi, Belgium; Leuven, Belgium; Liège, Belgium and 21 more location(s). 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.