Ischemic StrokePACIFIC-PFONCT06983795
Pioneering Advancements in Cardiocerebrovascular Interactions in the Asia pacFIC - Patent Foramen Ovale Study
An observational study of Ischemic Stroke and Patent Foramen Ovale, run by National University Hospital, Singapore at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke, Patent Foramen Ovale
- What is being tested?
- PFO closure using approved PFO closure devices, Surgical PFO closure and Medical management
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 1,000 participants
- Where
- 1 siteSingapore
- Study dates
- Jul 2025to Dec 2030
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with ischemic stroke or TIA and PFO identified would be screened for inclusion into the PACIFIC-PFO registry. Consecutive patients should be identified for inclusion by the local research team in each participating centers. Reason for exclusion after screening should be clearly stated and documented on a Screening and Enrollment Log, in order to minimize bias.
Who may be able to join
- 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
Who cannot join
- Stroke mimics, haemorrhagic stroke or cerebral venous thrombosis
- Subjects with less than 3 months of follow up
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Singapore1 site
National University Hospital
Singapore
Benjamin Y Tan, MBBS, +65 6779 5555, benjamin_yq_tan@nuhs.edu.sg
About this 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.
Read the 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
- Being tested
- PFO closure using approved PFO closure devices, Surgical PFO closure, Medical management
- Keywords
- Patent Foramen Ovale, Ischemic Stroke
- Medical subject headings
- Ischemic Stroke, Foramen Ovale, Patent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PFO closure using approved PFO closure devices, Surgical PFO closureProcedure or surgery
Also called Amplatzer™ Septal Occluder, Amplatzer™ PFO Occluder, Amplatzer™ Cribriform (for a septum with more than one hole), Gore® Cardioform Septal Occluder
PFO closure using approved PFO closure devices, Surgical PFO closure
Medical managementDrug
Also called Antiplatelet therapy e.g. aspirin, clopidogrel, ticagrelor, dipyridamole, cilostazol, or a combination of these medications, Anticoagulation e.g warfarin, direct oral anticoagulants
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)
| Study group | Role | What they receive |
|---|---|---|
| Patients diagnosed with patient foramen ovale and ischemic stroke or transient ischemic attack. | The PACIFIC-PFO registry aims to include patients from Asia and Oceania. Academic, non-academic, urban and rural sites will be included. Principal investigators will be neurologists or cardiologists. A confirmed diagnosis of ischemic stroke or TIA is mandatory before enrolment. Information on the interventions performed and treatment instigated (e.g. PFO closure, medical therapy) will be collected. Receives: Procedure: PFO closure using approved PFO closure devices, Surgical PFO closure; Drug: Medical management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrent ischemic stroke or transient ischemic attack event 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.
Measured: Within 1 year
Secondary outcomes (2)
Modified Rankin Scale (mRS)
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.
Measured: 90 days
Short term and long term neurological and cardiovascular outcomes
- 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
Measured: 90 days, 1 year, >1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2025
- Study startJul 2025 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06983795
- Sponsor's protocol ID
- PACIFIC-PFO
- Acronym
- PACIFIC-PFO
- Status last verified
- Oct 2024
- First submitted
- 28 Feb 2025
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared due to restrictions stipulated by Ethics Approval.
Publications
Saver JL, Mattle HP, Thaler D. Patent Foramen Ovale Closure Versus Medical Therapy for Cryptogenic Ischemic Stroke: A Topical Review. Stroke. 2018 Jun;49(6):1541-1548. doi: 10.1161/STROKEAHA.117.018153. Epub 2018 May 14. No abstract available.
PubMed 29760277Kim JS, Thijs V, Yudi M, Toyoda K, Shiozawa M, Zening J, Clapp B, Albers B, Diener HC. Establishment of the Heart and Brain Team for Patent Foramen Ovale Closure in Stroke Patients: An Expert Opinion. J Stroke. 2022 Sep;24(3):345-351. doi: 10.5853/jos.2022.02103. Epub 2022 Sep 30.
PubMed 36221937Toh KZX, Koh MY, Ho JSY, Ong KHX, Lee YQ, Chen X, Fang JT, Chong EY, Lim ICZY, Teo YH, Teo YN, Chua CYK, Lim Y, Chan BPL, Sharma VK, Yeo LLL, Sia CH, Tan BYQ. Potential Embolic Sources in Embolic Stroke of Undetermined Source Patients with Patent Foramen Ovale. Cerebrovasc Dis. 2023;52(5):503-510. doi: 10.1159/000527791. Epub 2022 Dec 1.
PubMed 36455524Diener HC, Akagi T, Durongpisitkul K, Thomson VS, Prabhakar AT, Sharpe R, Albers B, Lewalter T, Oki K, Sharma VK. Closure of the patent foramen ovale in patients with embolic stroke of undetermined source: A clinical expert opinion and consensus statement for the Asian-Pacific region. Int J Stroke. 2020 Dec;15(9):937-944. doi: 10.1177/1747493020941658. Epub 2020 Jul 17.
PubMed 32677579Kent DM, Saver JL, Ruthazer R, Furlan AJ, Reisman M, Carroll JD, Smalling RW, Juni P, Mattle HP, Meier B, Thaler DE. Risk of Paradoxical Embolism (RoPE)-Estimated Attributable Fraction Correlates With the Benefit of Patent Foramen Ovale Closure: An Analysis of 3 Trials. Stroke. 2020 Oct;51(10):3119-3123. doi: 10.1161/STROKEAHA.120.029350. Epub 2020 Sep 14.
PubMed 32921262Kent DM, Saver JL, Kasner SE, Nelson J, Carroll JD, Chatellier G, Derumeaux G, Furlan AJ, Herrmann HC, Juni P, Kim JS, Koethe B, Lee PH, Lefebvre B, Mattle HP, Meier B, Reisman M, Smalling RW, Soendergaard L, Song JK, Mas JL, Thaler DE. Heterogeneity of Treatment Effects in an Analysis of Pooled Individual Patient Data From Randomized Trials of Device Closure of Patent Foramen Ovale After Stroke. JAMA. 2021 Dec 14;326(22):2277-2286. doi: 10.1001/jama.2021.20956.
PubMed 34905030Kent DM, Ruthazer R, Weimar C, Mas JL, Serena J, Homma S, Di Angelantonio E, Di Tullio MR, Lutz JS, Elkind MS, Griffith J, Jaigobin C, Mattle HP, Michel P, Mono ML, Nedeltchev K, Papetti F, Thaler DE. An index to identify stroke-related vs incidental patent foramen ovale in cryptogenic stroke. Neurology. 2013 Aug 13;81(7):619-25. doi: 10.1212/WNL.0b013e3182a08d59. Epub 2013 Jul 17.
PubMed 23864310Turc G, Calvet D, Guerin P, Sroussi M, Chatellier G, Mas JL; CLOSE Investigators. Closure, Anticoagulation, or Antiplatelet Therapy for Cryptogenic Stroke With Patent Foramen Ovale: Systematic Review of Randomized Trials, Sequential Meta-Analysis, and New Insights From the CLOSE Study. J Am Heart Assoc. 2018 Jun 17;7(12):e008356. doi: 10.1161/JAHA.117.008356.
PubMed 29910193Overell JR, Bone I, Lees KR. Interatrial septal abnormalities and stroke: a meta-analysis of case-control studies. Neurology. 2000 Oct 24;55(8):1172-9. doi: 10.1212/wnl.55.8.1172.
PubMed 11071496Koutroulou I, Tsivgoulis G, Tsalikakis D, Karacostas D, Grigoriadis N, Karapanayiotides T. Epidemiology of Patent Foramen Ovale in General Population and in Stroke Patients: A Narrative Review. Front Neurol. 2020 Apr 28;11:281. doi: 10.3389/fneur.2020.00281. eCollection 2020.
PubMed 32411074
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pioneering Advancements in Cardiocerebrovascular Interactions in the Asia pacFIC - Patent Foramen Ovale Study
- ClinicalTrials.gov ID
- NCT06983795
- Acronym / sponsor ID
- PACIFIC-PFO / PACIFIC-PFO
- Conditions
- Ischemic Stroke, Patent Foramen Ovale
- Keywords
- Patent Foramen Ovale, Ischemic Stroke
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Study start
- Jul 2025 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 21 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients diagnosed with patient foramen ovale and ischemic stroke or transient ischemic attack. | – | Procedure: PFO closure using approved PFO closure devices, Surgical PFO closure, Drug: Medical managementThe PACIFIC-PFO registry aims to include patients from Asia and Oceania. Academic, non-academic, urban and rural sites will be included. Principal investigators will be neurologists or cardiologists. A confirmed diagnosis of ischemic stroke or TIA is mandatory before enrolment. Information on the interventions performed and treatment instigated (e.g. PFO closure, medical therapy) will be collected. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with ischemic stroke or TIA and PFO identified would be screened for inclusion into the PACIFIC-PFO registry. Consecutive patients should be identified for inclusion by the local research team in each participating centers. Reason for exclusion after screening should be clearly stated and documented on a Screening and Enrollment Log, in order to minimize bias.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Stroke mimics, haemorrhagic stroke or cerebral venous thrombosis
- Subjects with less than 3 months of follow up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PFO closure using approved PFO closure devices, Surgical PFO closureAlso: Amplatzer™ Septal Occluder, Amplatzer™ PFO Occluder, Amplatzer™ Cribriform (for a septum with more than one hole), Gore® Cardioform Septal OccluderPFO closure using approved PFO closure devices, Surgical PFO closure | Procedure or surgery | Patients diagnosed with patient foramen ovale and ischemic stroke or transient ischemic attack. |
| Medical managementAlso: Antiplatelet therapy e.g. aspirin, clopidogrel, ticagrelor, dipyridamole, cilostazol, or a combination of these medications, Anticoagulation e.g warfarin, direct oral anticoagulantsAntiplatelet 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) | Drug | Patients diagnosed with patient foramen ovale and ischemic stroke or transient ischemic attack. |
Primary outcome
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.
2 secondary outcomes
Modified Rankin Scale (mRS)
Time frame: 90 days
Short term and long term neurological and cardiovascular outcomes
Time frame: 90 days, 1 year, >1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
- Background: PubMed 29760277Saver JL, Mattle HP, Thaler D. Patent Foramen Ovale Closure Versus Medical Therapy for Cryptogenic Ischemic Stroke: A Topical Review. Stroke. 2018 Jun;49(6):1541-1548. doi: 10.1161/STROKEAHA.117.018153. Epub 2018 May 14. No abstract available.
- Background: PubMed 36221937Kim JS, Thijs V, Yudi M, Toyoda K, Shiozawa M, Zening J, Clapp B, Albers B, Diener HC. Establishment of the Heart and Brain Team for Patent Foramen Ovale Closure in Stroke Patients: An Expert Opinion. J Stroke. 2022 Sep;24(3):345-351. doi: 10.5853/jos.2022.02103. Epub 2022 Sep 30.
- Background: PubMed 36455524Toh KZX, Koh MY, Ho JSY, Ong KHX, Lee YQ, Chen X, Fang JT, Chong EY, Lim ICZY, Teo YH, Teo YN, Chua CYK, Lim Y, Chan BPL, Sharma VK, Yeo LLL, Sia CH, Tan BYQ. Potential Embolic Sources in Embolic Stroke of Undetermined Source Patients with Patent Foramen Ovale. Cerebrovasc Dis. 2023;52(5):503-510. doi: 10.1159/000527791. Epub 2022 Dec 1.
- Background: PubMed 32677579Diener HC, Akagi T, Durongpisitkul K, Thomson VS, Prabhakar AT, Sharpe R, Albers B, Lewalter T, Oki K, Sharma VK. Closure of the patent foramen ovale in patients with embolic stroke of undetermined source: A clinical expert opinion and consensus statement for the Asian-Pacific region. Int J Stroke. 2020 Dec;15(9):937-944. doi: 10.1177/1747493020941658. Epub 2020 Jul 17.
- Background: PubMed 32921262Kent DM, Saver JL, Ruthazer R, Furlan AJ, Reisman M, Carroll JD, Smalling RW, Juni P, Mattle HP, Meier B, Thaler DE. Risk of Paradoxical Embolism (RoPE)-Estimated Attributable Fraction Correlates With the Benefit of Patent Foramen Ovale Closure: An Analysis of 3 Trials. Stroke. 2020 Oct;51(10):3119-3123. doi: 10.1161/STROKEAHA.120.029350. Epub 2020 Sep 14.
- Background: PubMed 34905030Kent DM, Saver JL, Kasner SE, Nelson J, Carroll JD, Chatellier G, Derumeaux G, Furlan AJ, Herrmann HC, Juni P, Kim JS, Koethe B, Lee PH, Lefebvre B, Mattle HP, Meier B, Reisman M, Smalling RW, Soendergaard L, Song JK, Mas JL, Thaler DE. Heterogeneity of Treatment Effects in an Analysis of Pooled Individual Patient Data From Randomized Trials of Device Closure of Patent Foramen Ovale After Stroke. JAMA. 2021 Dec 14;326(22):2277-2286. doi: 10.1001/jama.2021.20956.
- Background: PubMed 23864310Kent DM, Ruthazer R, Weimar C, Mas JL, Serena J, Homma S, Di Angelantonio E, Di Tullio MR, Lutz JS, Elkind MS, Griffith J, Jaigobin C, Mattle HP, Michel P, Mono ML, Nedeltchev K, Papetti F, Thaler DE. An index to identify stroke-related vs incidental patent foramen ovale in cryptogenic stroke. Neurology. 2013 Aug 13;81(7):619-25. doi: 10.1212/WNL.0b013e3182a08d59. Epub 2013 Jul 17.
- Background: PubMed 29910193Turc G, Calvet D, Guerin P, Sroussi M, Chatellier G, Mas JL; CLOSE Investigators. Closure, Anticoagulation, or Antiplatelet Therapy for Cryptogenic Stroke With Patent Foramen Ovale: Systematic Review of Randomized Trials, Sequential Meta-Analysis, and New Insights From the CLOSE Study. J Am Heart Assoc. 2018 Jun 17;7(12):e008356. doi: 10.1161/JAHA.117.008356.
- Background: PubMed 11071496Overell JR, Bone I, Lees KR. Interatrial septal abnormalities and stroke: a meta-analysis of case-control studies. Neurology. 2000 Oct 24;55(8):1172-9. doi: 10.1212/wnl.55.8.1172.
- Background: PubMed 32411074Koutroulou I, Tsivgoulis G, Tsalikakis D, Karacostas D, Grigoriadis N, Karapanayiotides T. Epidemiology of Patent Foramen Ovale in General Population and in Stroke Patients: A Narrative Review. Front Neurol. 2020 Apr 28;11:281. doi: 10.3389/fneur.2020.00281. eCollection 2020.
- Individual participant dataSharing planned: No. IPD will not be shared due to restrictions stipulated by Ethics Approval.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Stroke and Patent Foramen Ovale, run by National University Hospital, Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Benjamin Y Tan, MBBS (+65 6779 5555, benjamin_yq_tan@nuhs.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrent ischemic stroke or transient ischemic attack event within 1 year (time frame: Within 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06983795, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2025.