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NCT Number: NCT06983795

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

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.

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Key information

Conditions

Ischemic Stroke Brain Diseases Cardiovascular Abnormalities Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Foramen Ovale, Patent Heart Defects, Congenital Heart Diseases Heart Septal Defects Heart Septal Defects, Atrial Nervous System Diseases Patent Foramen Ovale Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject has experienced acute ischemic stroke or transient ischemic attack
  • Subject is screened with presence of PFO (right-to-left shunt) on appropriate cardiac imaging (transthoracic echocardiography and/or transesophageal echocardiography) or transcranial Doppler bubble study
  • Age ≥18 years

Exclusion criteria

  • Stroke mimics, haemorrhagic stroke or cerebral venous thrombosis
  • Subjects with less than 3 months of follow up

Treatment and study plan

PFO closure using approved PFO closure devices, Surgical PFO closure

Procedure

PFO closure using approved PFO closure devices, Surgical PFO closure

Other names: Amplatzer™ Septal Occluder, Amplatzer™ PFO Occluder, Amplatzer™ Cribriform (for a septum with more than one hole), Gore® Cardioform Septal Occluder, Gore® Cardioform ASD Occluder (for larger ASDs), STARFlex® Septal Closure System

Medical Management

Drug

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)

Other names: Antiplatelet therapy e.g. aspirin, clopidogrel, ticagrelor, dipyridamole, cilostazol, or a combination of these medications, Anticoagulation e.g warfarin, direct oral anticoagulants

Primary outcomes

  1. Recurrent ischemic stroke or transient ischemic attack event within 1 year

    Time frame: Within 1 year

    Ischemic stroke is defined as:

    Acute focal neurological dysfunction caused by focal infarction at single or multiple sites of the brain or retina. Evidence of acute infarction may come either from A) Symptom duration lasting more than 24 hours B) Neuroimaging or other technique in the clinically relevant area of the brain

    TIA is defined as:

    A transient episode of focal neurological dysfunction caused by focal brain or retinal ischemia without acute infarction in the clinically relevant area of the brain or retina.

    Symptoms should resolve completely within 24 hours.

Secondary outcomes

  1. Modified Rankin Scale (mRS)

    Time frame: 90 days

    The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale runs from 0-6, running from perfect health without symptoms to death.

  2. Short term and long term neurological and cardiovascular outcomes

    Time frame: 90 days, 1 year, >1 year

    • Recurrent stroke or TIA
    • Systemic embolism
    • Acute myocardial infarction
    • Cardiovascular mortality
    • All-cause mortality
    • Major and minor bleeding defined according to the ISTH criteria
    • Intracranial hemorrhage

Other outcomes

  1. To validate PFO risk stratification scores in an Asia-Pacific cohort - RoPE score

    Time frame: 5 years

    PFO risk stratification scores are widely used to determine the likelihood that PFO discovered in the setting of an otherwise-cryptogenic stroke was pathogenically related to the stroke rather than an incidental finding.

    ROPE score The RoPE score ranges from 0 to 10, with scores of 0 to 3 indicating a negligible likelihood that the stroke is attributable to the PFO and a score of 10 indicating an approximately 90% probability that the stroke is attributable to the PFO.

  2. To validate PFO risk stratification scores in an Asia-Pacific cohort - PASCAL score

    Time frame: 5 years

    PFO risk stratification scores are widely used to determine the likelihood that PFO discovered in the setting of an otherwise-cryptogenic stroke was pathogenically related to the stroke rather than an incidental finding.

    PASCAL score PASCAL combines the RoPE score with the presence or absence of high-risk PFO features to determine the likelihood that the PFO was causally related to the index stroke

  3. To validate PFO risk stratification scores in an Asia-Pacific cohort - Spencer Grading

    Time frame: 5 years

    PFO risk stratification scores are widely used to determine the likelihood that PFO discovered in the setting of an otherwise-cryptogenic stroke was pathogenically related to the stroke rather than an incidental finding.

    Spencer algorithm grading scale with transcranial Doppler bubble study methodology

  4. To evaluate the impact of access to PFO closure and availability of heart-brain teams on patient outcomes

    Time frame: 5 years

    The outcomes of the patients will be compared between centres with PFO closures services and heart-brain teams with those without. Patients treated by a heart-brain multi-disciplinary team were compared to those who were not.

  5. To compare our regional data with other real-world registries or clinical trial data

    Time frame: 5 years

    To compare the patient characteristics, investigations, treatment and management in this regional registry with other published registries or clinical trials.

  6. Other objectives

    Time frame: 5 years

    To identify other variables associated with PFO-related stroke specific to the Asian population, and to develop Asian-specific risk stratification methods which may have higher predictive values. Exploratory analysis of patients with PFO closure will be performed, for outcomes such as incidence of atrial fibrillation.

Study contacts

Contact information is provided by the study sponsor or research team.

Benjamin Y Tan, MBBS

CONTACT

[email protected]

+65 6779 5555

Ching-Hui Sia, MBBS

CONTACT

[email protected]

+65 6779 5555

Sponsors and collaborators

Lead sponsor

National University Hospital, Singapore

Other

Registry information

Acronym: PACIFIC-PFO

Important dates

Study start
2025
Primary completion
2027
Study completion
2030
First posted
May 21, 2025
Registry last updated
May 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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