NCT07479147 SENIOR: Stroke Prevention in the Elderly by Patent Foramen Ovale closuRe vs Anticoagulation
| NCT ID | NCT07479147 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Taichung Veterans General Hospital |
| Condition | Ischemic Stroke |
| Study Type | OBSERVATIONAL |
| Enrollment | 400 participants |
| Start Date | 2025-12-16 |
| Primary Completion | 2031-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 400 participants in total. It began in 2025-12-16 with a primary completion date of 2031-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Patent foramen ovale (PFO) is an important mechanism of embolic stroke of undetermined source (ESUS). Current guidelines recommend PFO closure for high-risk PFO in patients younger than 60 years, and a recent retrospective cohort study from Taichung Veterans General Hospital has shown that closure is effective and safe in older adults; however, the optimal treatment strategy for those \>60 years and direct head-to-head comparisons of PFO closure versus direct oral anticoagulants (DOACs) remain insufficient. Robust evidence from a multicenter study combining prospective and retrospective cohorts is warranted. The SENIOR study is a multicenter observational cohort registry with a combined retrospective and prospective design. The prospective period is from September 15, 2025 to December 31, 2031, and the retrospective period covers January 1, 2013 to September 1, 2025; target sample sizes are 400 (prospective) and 500 (retrospective). We will enroll adults with ESUS and PFO; the prospective arm will focus on patients aged \>60 years with PFO related stroke. Treatments will be assigned as PFO closure, standard-dose DOAC, or antiplatelet agents (if DOAC intolerance) by local principal investigator. The primary outcome is recurrent ischemic stroke or transient ischemic attack. Secondary outcomes include 6-month functional outcome, all stroke, and serial comparison of atrial cardiopathy changes. Safety endpoints include peri-procedural adverse events (including newly-onset atrial fibrillation), hemorrhagic stroke, and all caused mortality. Clinical presentation, imaging, cardiac testing, biomarker, and genetic data will be collected for stratified and multivariable analyses.
Eligibility Criteria
Inclusion Criteria: * Patient or his/her legal representative signs a written informed consent * Participants who have diagnosed as PFO related stroke * For patient aged 18-59: patient with high risk PFO feature or RoPE score ≥ 7 * For patient aged 60-90: patient with high risk PFO feature or RoPE score ≥ 4, must include cortical infarct Exclusion Criteria: * Follow-up less than 6 months * Extracardiac right-to-left shunt * Known stroke mechanism was diagnosed
Contact & Investigator
I-Hui Lee, MD, PhD
PRINCIPAL INVESTIGATOR
Taipei Veterans General Hospital, Taiwan
Frequently Asked Questions
Who can join the NCT07479147 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Ischemic Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07479147 currently recruiting?
Yes, NCT07479147 is actively recruiting participants. Contact the research team at sam7227632@gmail.com for enrollment information.
Where is the NCT07479147 trial being conducted?
This trial is being conducted at Taichung, Taiwan, Taipei, Taiwan, Taipei, Taiwan.
Who is sponsoring the NCT07479147 clinical trial?
NCT07479147 is sponsored by Taichung Veterans General Hospital. The principal investigator is I-Hui Lee, MD, PhD at Taipei Veterans General Hospital, Taiwan. The trial plans to enroll 400 participants.
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