PFO Closure for Stroke

(STOP Trial)

Overseen By Melanie Cote, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Josep Rodes-Cabau

Must not be taking: Anticoagulants, Antiplatelets

Disqualifiers: Atrial fibrillation, Hypertension, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if closing a tiny hole in the heart, known as a patent foramen ovale (PFO), can help prevent additional strokes in older adults who have experienced unexplained strokes. Researchers are comparing two treatments: one group will undergo a procedure to close the PFO (transcatheter PFO closure) along with medication, while the other group will receive only medication (optimal medical treatment) to manage stroke risk factors such as high blood pressure or cholesterol. Individuals over 60 who have had a stroke with no clear cause and have been diagnosed with a PFO might be suitable for this study. As an unphased trial, this study provides a unique opportunity to contribute to important research that could lead to improved stroke prevention strategies.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you need chronic anticoagulation therapy or have a contraindication for antiplatelet therapy like aspirin or clopidogrel.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that closing a patent foramen ovale (PFO) using a catheter is generally safe. Studies have found that this procedure helps prevent strokes in individuals with a history of unexplained strokes. In one study, only 1.5% of participants who underwent PFO closure experienced another stroke after nine years.

For individuals over 60, a real-world study found that PFO closure lowered the risk of future strokes more effectively than medication alone. Over approximately 3.6 years, those who had the procedure were less likely to experience a stroke compared to those who only took blood-thinning medication.

In summary, both PFO closure and optimal medical treatments are safe, but the procedure can significantly reduce stroke risk for many patients. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about transcatheter PFO closure for stroke because it offers a novel approach to treatment. Unlike the standard medical therapies that focus on managing risk factors and using medications like antiplatelet agents, this procedure directly addresses the heart defect known as a patent foramen ovale (PFO), which is linked to stroke. By closing the PFO through a minimally invasive catheter procedure, it has the potential to significantly reduce the risk of recurrent strokes in patients, providing a more targeted solution than conventional medical management alone.

What evidence suggests that this trial's treatments could be effective for preventing recurrent stroke in older patients?

Research has shown that closing a small hole in the heart, known as a patent foramen ovale (PFO), can greatly reduce the risk of another stroke, especially in individuals who have had strokes with no clear cause. In this trial, participants will be assigned to one of two treatment arms: one group will undergo transcatheter PFO closure combined with optimal medical treatment, while the other group will receive optimal medical treatment alone. Studies have found that individuals who undergo the PFO closure procedure are less likely to experience another stroke in the long run compared to those who only take medication to prevent blood clots. This indicates that closing the PFO can be very effective in preventing future strokes. However, most research has focused on younger individuals, so more information is needed on its effectiveness for those over 60 years old. ^{2 5 6 7 8}

Who Is on the Research Team?

IUCPQ Rodes-Cabau, MD, PhD

Principal Investigator

Fondation IUCPQ

Are You a Good Fit for This Trial?

This trial is for individuals over 60 years old who have had a cryptogenic stroke, which means the cause of their stroke was unknown, and they also have a patent foramen ovale (PFO), a small opening in the heart. They must show evidence of right-to-left shunt on an echocardiogram.

Inclusion Criteria

I had a stroke with an unknown cause.

I am older than 60 years.

You have a heart condition called a right-to-left shunt, as confirmed by an echocardiogram.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either transcatheter PFO closure with optimal medical treatment or optimal medical treatment alone

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of stroke events and mortality

10 years

What Are the Treatments Tested in This Trial?

Interventions

• Optimal medical treatment
• Transcatheter PFO closure

Trial Overview The study is testing whether closing the PFO with a special procedure called transcatheter closure can prevent future strokes compared to just receiving optimal medical treatment without closure. The participants will be randomly assigned to one of these two approaches.

How Is the Trial Designed?

Group I: transcatheter PFO closure + optimal medical treatment Experimental Treatment 2 Interventions

Patients will undergoes transcatheter PFO closure (+ optimal medical treatment). Patients will receive antithrombotic agents (single antiplatelet treatment ), and modifiable vascular risk factors (dyslipidemia, hypertension, diabetes) according to stroke prevention guidelines. The type of antithrombotic therapy will be left to the discretion of the physician responsible for the patient.

Group II: Optimal medical treatment Experimental Treatment 1 Intervention

Patients will receive antithrombotic agents (single antiplatelet treatment ), and modifiable vascular risk factors (dyslipidemia, hypertension, diabetes) according to stroke prevention guidelines. The type of antithrombotic therapy will be left to the discretion of the physician responsible for the patient.

Who Is Running the Clinical Trial?

Josep Rodes-Cabau

Lead Sponsor

Trials

4

Recruited

1,400+

Citations

1. ahajournals.org ahajournals.org/doi/10.1161/JAHA.123.030321

Effectiveness of Transcatheter Closure of Patent Foramen ... Transcatheter closure of patent foramen ovale (PFO) has reduced the risk of recurrent stroke in patients with cryptogenic strokes in ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39460481/

Stroke recurrence after transcatheter PFO closure in ... In this real-world cohort, transcatheter PFO closure was associated with low long-term recurrence of neurologic events, especially cryptogenic strokes.

3. eurointervention.pcronline.com eurointervention.pcronline.com/article/long-term-effectiveness-and-safety-of-transcatheter-closure-of-patent-foramen-ovale-compared-with-antithrombotic-therapy-alone-a-meta-analysis-of-six-randomised-clinical-trials-and-3560-patients-with-reconstructed-time-to-event-data

Long-term effectiveness and safety of transcatheter closure of ... At a median follow-up of 3.6 (2.0-5.2) years (13,930 person-years), the risk of stroke was significantly lower after tPFOc compared with ATA (HR 0.28, 95% CI: ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1052305724006323

a systematic review and meta-analysis In this first meta-analysis of observational studies, we found that real-world studies report a low long-term risk of recurrent stroke after PFO closure, and ...

5. frontiersin.org frontiersin.org/journals/cardiovascular-medicine/articles/10.3389/fcvm.2024.1391886/full

Transcatheter PFO closure for cryptogenic stroke The Gore Septal Occluder Device for PFO Closure in Stroke Patients (REDUCE) trial showed remarkable benefit and reduction in the risk of ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5699514/

Safety Outcomes After Percutaneous Transcatheter ... Observational data suggest that percutaneous transcatheter closure of PFO for secondary stroke prevention is safe and effective; however, three recent ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0167527322013833

Real world long-term outcomes among adults undergoing ... In this study, the risk of recurrent stroke at 9 years follow-up post PFO closure with Amplatzer PFO Occluder was 1.5%.

8. jacc.org jacc.org/doi/10.1016/j.jcin.2025.03.034

PFO Device Closure in Patients >60 Years of Age With ... In a real-world US cohort of patients >60 years of age, PFO closure was associated with a reduced risk for recurrent ischemic stroke compared with medical ...