Pioneering Advancements in Cardiocerebrovascular Interactions in the Asia pacFIC - Patent Foramen Ovale Study
NCT ID: NCT06983795
Last Updated: 2025-05-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
1000 participants
OBSERVATIONAL
2025-07-31
2030-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
OTHER
Study Groups
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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.
PFO closure using approved PFO closure devices, Surgical PFO closure
PFO closure using approved PFO closure devices, Surgical PFO closure
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)
Interventions
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PFO closure using approved PFO closure devices, Surgical PFO closure
PFO closure using approved PFO closure devices, Surgical PFO closure
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)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. 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
3. Age ≥18 years
Exclusion Criteria
2. Subjects with less than 3 months of follow up
18 Years
ALL
No
Sponsors
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National University Hospital, Singapore
OTHER
Responsible Party
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Locations
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National University Hospital
Singapore, , Singapore
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Kim 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.
Toh 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.
Diener 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.
Kent 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.
Kent 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.
Kent 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.
Turc 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.
Overell 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.
Koutroulou 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.
Other Identifiers
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PACIFIC-PFO
Identifier Type: -
Identifier Source: org_study_id
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