NCT06983795

Pioneering Advancements in Cardiocerebrovascular Interactions in the Asia pacFIC - Patent Foramen Ovale Study

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: National University Hospital, Singapore · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A registry of patients from the Asia-Pacific region with PFO and ischemic stroke, designed to study the characteristics, investigations, treatment and outcomes using real-world data.

Detailed description

This is an observational, multi-center, non-randomized real-world registry including ischemic stroke and/or transient ischemic attack patients with PFO in the Asia Pacific region. The primary objective of this registry is to assess the clinical characteristics and outcomes of patients with PFO and stroke or TIA using real-world data in the Asia-Pacific region, including patients who underwent PFO closure versus medical management only. Patients who had ischemic stroke or TIA within 5 years of inclusion into the registry, with follow up data of at least 1 year. Patients with AIS or TIA within one year of inclusion into the registry will be part of the prospective cohort. The total duration of the registry will be approximately 3 years.

Conditions

• Ischemic Stroke
• Patent Foramen Ovale

Interventions

Type	Name	Description
PROCEDURE	PFO closure using approved PFO closure devices, Surgical PFO closure	PFO closure using approved PFO closure devices, Surgical PFO closure
DRUG	Medical management	Antiplatelet therapy * ASA, also called acetylsalicylic acid (Aspirin, Asaphen, Entrophen, Novasen) * clopidogrel (Plavix) * ticagrelor (Brilinta) * dipyridamole (Persantine) * cilostazol Anticoagulation therapy * apixaban (Eliquis) * dabigatran (Pradaxa) * edoxaban (Lixiana) * rivaroxaban (Xarelto) * warfarin (Coumadin)

Timeline

• Start date: 2025-07-01
• Primary completion: 2027-12-01
• Completion: 2030-12-01
• First posted: 2025-05-21
• Last updated: 2025-05-21

Locations

1 site across 1 country: Singapore