Medical Treatment With or Without Transcatheter Patent Foramen Ovale CloSure for Older Patients With CrypTogenic StrOke and Patent Foramen Ovale. The STOP Trial
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug, Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
Patent foramen ovale PFO closure has been shown to reduce the risk of stroke in patients with recurrent stroke. However, the majority of existing clinical studies in this field excluded patients over the age of 60 years. Data in older patients is limited and since the population ages and stroke remains a major cause of death and morbidity, randomized clinical trials are needed to better assess the benefit of PFO closure in this elderly population. Therefore, this study proposal sought to determine the efficacy of PFO closure for the prevention of recurrent stroke in older patients with PFO and cryptogenic stroke.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Cryptogenic stroke
• Age \>60 years
• Right-to-left shunt as evaluated by echocardiography (TEE).
Locations
Other Locations
Canada
IUCPQ
RECRUITING
Québec
IUCPQ-UL
ACTIVE_NOT_RECRUITING
Québec
Contact Information
Primary
Josep Rodes-Cabau, MD, PhD
josep.rodes@criucpq.ulaval.ca
4186568711
Backup
Melanie Cote, MSc
melanie.cote@criucpq.ulaval.ca
4186568711
Time Frame
Start Date: 2024-06-18
Estimated Completion Date: 2037-10-01
Participants
Target number of participants: 714
Treatments
Experimental: transcatheter PFO closure + optimal medical treatment
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.
Experimental: 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.
Related Therapeutic Areas
Sponsors
Leads: Josep Rodes-Cabau