Clinical trial for Patent Foramen Ovale
Official title Discontinuation of Antithrombotic Treatment Following Patent Foramen Ovale Closure in Young Patients With Cryptogenic Stroke
ClinicalTrials.gov ID: NCT04475510
What this study is testing
- What it's testing
- The study wants to find out whether it is safe to stop antithrombotic (blood‑thinner) treatment 12 months after a successful transcatheter closure of a patent foramen ovale.
- Who it's for
- Young adults who had a cryptogenic (unknown‑cause) stroke and have had their patent foramen ovale closed.
- What's involved
- Participants will discontinue their antithrombotic medication after 12 months and will have follow‑up visits and safety checks to monitor for any problems.
- Time commitment
- The study follows participants for at least 12 months after the closure, with scheduled clinic visits and tests during that time.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60. Healthy volunteers may be eligible.
You may be able to join if
- Successful transcatheter PFO closure with any approved device
- Patients ≤60 years diagnosed with a cryptogenic stroke/TIA who have undergone successful transcatheter PFO closure
You likely can't join if
- -\>60 year-old
- RoPE score \<6
- Residual shunt ≥moderate following PFO closure
- Atrial fibrillation following PFO closure
- Presence of ≥2 cardiovascular risk factors (smoking, hypertension, dyslipidemia)
- Diabetes mellitus
See the full eligibility criteria
- Successful transcatheter PFO closure with any approved device
- Patients ≤60 years diagnosed with a cryptogenic stroke/TIA who have undergone successful transcatheter PFO closure
- -\>60 year-old
- RoPE score \<6
- Residual shunt ≥moderate following PFO closure
- Atrial fibrillation following PFO closure
- Presence of ≥2 cardiovascular risk factors (smoking, hypertension, dyslipidemia)
- Diabetes mellitus
- Thrombophilia (factor V Leiden, factor II mutation, anticardiolipin antibodies, lupus anticoagulant, anti-b2 glycoprotein-I antibodies, protein C deficiency, protein S deficiency)
- Recurrent cerebrovascular event (stroke, TIA) within the year following PFO closure
- Failure to provide signed informed consent
- Absolute contraindications for an MRI study
The study team makes the final eligibility decision.
Where it is enrolling
- Québec, Quebec, Canada
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, but 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 to 60 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Québec, Quebec, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.