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New treatment option for Cryptogenic Ischemic Stroke
Official title PFO Closure, Oral Anticoagulants or Antiplatelet Therapy After PFO-associated Stroke in Patients Aged 60 to 80 Years
ClinicalTrials.gov ID: NCT05387954
What this study is testing
What is Oral Anticoagulant, Direct-Acting?
Oral Anticoagulant, Direct-Acting is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for cryptogenic 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
- To assess whether PFO closure plus antiplatelet therapy is superior to antiplatelet therapy alone and whether oral anticoagulant therapy is superior to antiplatelet therapy to prevent stroke recurrence in patients aged 60 to 80 years with a PFO with large shunt (\> 20 microbubbles) or a PFO associated with an ASA (\> 10 mm), and an otherwise unexplained ischemic stroke.
- 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 60 to 80
You may be able to join if
- Man or woman aged 60 to 80 years.
- Recent (≤ 6 months) ischemic stroke confirmed by cerebral imaging regardless of symptom duration.
- Absence of a more probable cause of stroke than PFO after a standardized etiological work-up (see addenda).
- Presence of a PFO with at least 1 of the 2 following characteristics:
- PFO with large shunt (\> 20 microbubbles) appearing in the left atrium during at least one of the 3 cardiac cycles after complete opacification of...
You likely can't join if
- Life expectancy \< 4 years.
- Contraindication to both experimental treatments (PFO closure, oral anticoagulant therapy) or to the reference treatment (antiplatelet therapy) (see...
- Indication to long-term anticoagulant therapy.
- mRS \> 3.
- Presence of other medical conditions that would lead to inability to complete the study or interfere with the assessment of outcomes.
- Previous surgical or transcatheter treatment of PFO or ASA. Expected impossible follow-up or poor compliance.
See the full eligibility criteria
- Man or woman aged 60 to 80 years.
- Recent (≤ 6 months) ischemic stroke confirmed by cerebral imaging regardless of symptom duration.
- Absence of a more probable cause of stroke than PFO after a standardized etiological work-up (see addenda).
- Presence of a PFO with at least 1 of the 2 following characteristics:
- PFO with large shunt (\> 20 microbubbles) appearing in the left atrium during at least one of the 3 cardiac cycles after complete opacification of the right atrium, detected either spontaneously or during provocative...
- PFO associated with an ASA on transoesophageal echocardiography: excursion \>10 mm
- Affiliation to a French Health Insurance system. Informed consent.
- Life expectancy \< 4 years.
- Contraindication to both experimental treatments (PFO closure, oral anticoagulant therapy) or to the reference treatment (antiplatelet therapy) (see paragraph 20.5).
- Indication to long-term anticoagulant therapy.
- mRS \> 3.
- Presence of other medical conditions that would lead to inability to complete the study or interfere with the assessment of outcomes.
- Previous surgical or transcatheter treatment of PFO or ASA. Expected impossible follow-up or poor compliance.
- PFO associated with an atrial septal defect (ASD) requiring closure (significant shunt with impact on the right cavities, elevation of pulmonary pressures or QP/QS\>2)
- Patient unable to understand the informed consent form. Patient under tutorship, curatorship, or legal protection.
The study team makes the final eligibility decision.
Where it's taking place
- Amiens, France
- Bayonne, France
- Besançon, France
- Bordeaux, France
- Brest, France
- Bron, France
- Caen, France
- Clermont-Ferrand, France
- Corbeil-Essonnes, France
- Créteil, France
- Dijon, France
- Garches, France
- Grenoble, France
- La Rochelle, France
- Le Chesnay, France
- Le Kremlin-Bicêtre, France
- Lille, France
- Limoges, France
- Marseille, France
- Meaux, France
+ 18 more site(s).
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, 60 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amiens, France; Bayonne, France; Besançon, France; Bordeaux, France; Brest, France; Bron, France and 32 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.