Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID05907694

Medical Treatment With or Without Transcatheter Patent Foramen Ovale Closure for Older Patients With Cryptogenic Stroke and Patent Foramen Ovale: The STOP Trial

Led by Josep Rodes-Cabau · Updated on 2026-03-27

714

Participants Needed

2

Research Sites

521 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating the effectiveness of closing a patent foramen ovale (PFO) to prevent recurrent stroke in older patients who have had a cryptogenic stroke, a type of stroke with an unknown cause. While previous studies have shown PFO closure benefits in younger patients under 60, data for patients over 60 is limited. This trial aims to provide clear evidence on whether PFO closure reduces stroke risk in this older population. The study compares two groups: one receiving transcatheter PFO closure plus optimal medical treatment, and the other receiving only optimal medical treatment. Both groups will be given antithrombotic agents (single antiplatelet treatment) and management of vascular risk factors like dyslipidemia, hypertension, and diabetes according to stroke prevention guidelines. The PFO closure procedure will use approved occluder devices and be performed by experienced centers. Participants will be monitored for ischemic events over 12 months, with additional assessments planned over a 10-year follow-up. Researchers will evaluate stroke rates, mortality, cardiovascular mortality, cerebral hemorrhage, new atrial fibrillation, bleeding, quality of life, and cognitive function. The study involves regular health checks and long-term follow-up to assess the outcomes and safety of the interventions.

CONDITIONS

Brief Title

Medical Treatment With or Without Transcatheter Patent Foramen Ovale Closure

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of cryptogenic stroke
  • Age over 60 years
  • Right-to-left heart shunt confirmed by echocardiography (TEE)
Not Eligible

You will not qualify if you...

  • Age 60 years or younger
  • Lacunar (small vessel) stroke
  • Permanent or paroxysmal atrial fibrillation or flutter
  • Need for chronic anticoagulation therapy
  • Contraindication to antiplatelet therapy (aspirin, clopidogrel, ticagrelor)
  • Significant extracranial or intracranial artery stenosis (50% or more)
  • Complex atheroma plaques in the ascending aorta or aortic arch
  • Intracardiac thrombus
  • Uncontrolled hypertension despite treatment (blood pressure >160/90 mmHg)
  • History of myocardial infarction or coronary intervention
  • Prior valve surgery or transcatheter valve repair
  • Deep venous thrombosis at the time of stroke
  • Left ventricular ejection fraction less than 50%
  • Moderate or severe valvular disease
  • History of congestive heart failure
  • Severe chronic kidney dysfunction or need for dialysis
  • Isolated atrial septal defect or significant left-to-right shunt requiring closure
  • Other specific causes of stroke identified
  • Previous surgical or endovascular PFO or ASD treatments
  • Rheumatic heart disease
  • Left atrial enlargement beyond specified size
  • High burden of premature atrial contractions (>500 per 24 hours)
  • Inability to comply with follow-up
  • Active cancer
  • Presence of an inferior vena cava filter
  • Severe pulmonary artery hypertension (systolic pressure >60 mmHg)
  • Functional dependency (modified Rankin Scale score >3)
  • Life expectancy less than 2 years
  • Participation in another randomized study
  • Failure to provide signed informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) for screening and enrollment

Treatment

Duration - 12 months

Participants receive either transcatheter PFO closure along with optimal medical treatment or optimal medical treatment alone to prevent recurrent ischemic stroke.

Regular visits as per physician's discretion during treatment

Follow-up

Duration - Up to 10 years

Participants are monitored for long-term outcomes including stroke recurrence, cardiovascular events, bleeding, and quality of life.

Periodic follow-up visits for assessments over 10 years

Trial Site Locations

Total: 2 locations

1

IUCPQ-UL

Québec, Quebec, Canada, G1V 4G5

Active, Not Recruiting

2

IUCPQ

Québec, Quebec, Canada, G2E4G9

Actively Recruiting

Loading map...

Research Team

J

Josep Rodes-Cabau, MD, PhD

M

Melanie Cote, MSc

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Similar Trials

Subtle Ultrasound Atrial Anomalies Predict Early Silent Atri...

Paroxysmal Atrial Fibrillation

Actively Recruiting

1 location

CeraFlex PFO Closure System Post-Market Clinical Follow-up S...

Patent Foramen Ovale

Actively Recruiting

15 locations

Discontinuation of Antithrombotic Treatment Following Patent...

Patent Foramen Ovale

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

2021 Guideline for the Prevention of Stroke in Patients With Stroke and Transient Ischemic Attack: A Guideline From the American Heart Association/American Stroke Association.

Dawn O Kleindorfer, Amytis Towfighi, Seemant Chaturvedi...

https://pubmed.ncbi.nlm.nih.gov/34024117

Global, regional, and national burden of neurological disorders, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016.

GBD 2016 Neurology Collaborators

https://pubmed.ncbi.nlm.nih.gov/30879893

Trends in the incidence of recurrent stroke at 5 years after the first-ever stroke in rural China: a population-based stroke surveillance from 1992 to 2017.

Wenjuan Zhao, Jialing Wu, Jie Liu...

https://pubmed.ncbi.nlm.nih.gov/30888967

Meta-analysis of transcatheter closure versus medical therapy for patent foramen ovale in prevention of recurrent neurological events after presumed paradoxical embolism.

Shikhar Agarwal, Navkaranbir Singh Bajaj, Dharam J Kumbhani...

https://pubmed.ncbi.nlm.nih.gov/22814784