NCT05238610

Brief Summary

Patent foramen ovale (PFO) is associated with an increased risk of stroke. PFO-closure was effective in preventing stroke in young stroke patients less than age 60 presented as an embolic stroke of undetermined source (ESUS). However, the benefit of PFO-closure in elderly ESUS patients is not clear. The investigators designed this prospective register-based observational study to verify the efficacy of PFO-closure in elderly ESUS patients with high-risk PFO, older than 60 years

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,200

participants targeted

Target at P75+ for all trials

Timeline
13mo left

Started Jan 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress80%
Jan 2022May 2027

Study Start

First participant enrolled

January 17, 2022

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

February 2, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 14, 2022

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2027

Last Updated

February 14, 2022

Status Verified

February 1, 2022

Enrollment Period

4.4 years

First QC Date

February 2, 2022

Last Update Submit

February 11, 2022

Conditions

Embolic Stroke of Undetermined Source

Keywords

insertable loop recorderpatent foramen ovalepatent foramen ovale closureelderly

Outcome Measures

Primary Outcomes (1)

  • ischemic stroke recurrence

    Time to occurrence of ischemic stroke after registration

    at least 1 year

Secondary Outcomes (7)

  • MACE

    at least 1 year

  • Hemorrhagic stroke

    at least 1 year

  • Vascular death

    at least 1 year

  • Myocardial infarction

    at least 1 year

  • Atrial fibrillation after registration

    at least 1 year

  • +2 more secondary outcomes

Study Arms (2)

Experimental: intervention group

This group will receive PFO-closure and standard antiplatelet treatment PFO-closure will be performed after 3-6 months of observation and monitoring for paroxysmal atrial fibrillation Standard antiplatelet treatment will be prescribed - aspirin 100mg and clopidogrel 75mg, once daily, principally. However, the final decision of antiplatelet treatment will be made by the physician. If paroxysmal atrial fibrillation is detected, anticoagulation will be considered. Intervention : PFO closure Drug: aspirin 100mg/day Drug: clopidogrel 75mg/day

Procedure: PFO closure

Active comparator: control group

This group will receive standard antiplatelet treatment only Dual antiplatelet treatment with Aspirin 100mg and Clopidogrel 75mg, once daily, or single antiplatelet treatment with those agents can be considered. If paroxysmal atrial fibrillation is detected, anticoagulation will be considered. Drug: aspirin 100mg/day Drug: clopidogrel 75mg/day

Interventions

PFO closurePROCEDURE

PFO-closure will be performed after 3-6 month of observation and monitoring for paroxysmal atrial fibrillation

Experimental: intervention group

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Elderly ESUS patients

You may qualify if:

  • Patients older than 60 years-old
  • Patients diagnosed as ESUS within 180 days from onset
  • PFO found from TTE or TEE, which attributed to the ischemic stroke
  • Patients or their legal representative agreed to participate

You may not qualify if:

  • Patients with transient ischemic attack
  • Patients with ischemic stroke at the vascular territory with significant stenosis
  • Patients with high risk cardioembolic stroke detected from EKG, Holter monitoring or echocardiography
  • Patients with other causes which may cause stroke (i.e. vasculitis, dissection, vasospasm, drug related or Moyamoya disease)
  • Patients with active cancer
  • Patients who need long term anticoagulation
  • Patients who have side effect on antiplatelet treatment
  • Patients with active internal bleeding
  • Patients who refuse to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, 05055, South Korea

RECRUITING

Related Publications (7)

  • Kwon H, Lee PH, Song JK, Kwon SU, Kang DW, Kim JS. Patent Foramen Ovale Closure in Old Stroke Patients: A Subgroup Analysis of the DEFENSE-PFO Trial. J Stroke. 2021 May;23(2):289-292. doi: 10.5853/jos.2021.00647. Epub 2021 May 31. No abstract available.

    PMID: 34102766BACKGROUND

  • Park S, Oh JK, Song JK, Kwon B, Kim BJ, Kim JS, Kang DW, Chang JY, Lee JS, Kwon SU. Transcranial Doppler as a Screening Tool for High-Risk Patent Foramen Ovale in Cryptogenic Stroke. J Neuroimaging. 2021 Jan;31(1):165-170. doi: 10.1111/jon.12783. Epub 2020 Sep 8.

    PMID: 32896963BACKGROUND

  • Lee PH, Song JK, Kim JS, Heo R, Lee S, Kim DH, Song JM, Kang DH, Kwon SU, Kang DW, Lee D, Kwon HS, Yun SC, Sun BJ, Park JH, Lee JH, Jeong HS, Song HJ, Kim J, Park SJ. Cryptogenic Stroke and High-Risk Patent Foramen Ovale: The DEFENSE-PFO Trial. J Am Coll Cardiol. 2018 May 22;71(20):2335-2342. doi: 10.1016/j.jacc.2018.02.046. Epub 2018 Mar 12.

    PMID: 29544871BACKGROUND

  • Kim BJ, Kim NY, Kang DW, Kim JS, Kwon SU. Provoked right-to-left shunt in patent foramen ovale associates with ischemic stroke in posterior circulation. Stroke. 2014 Dec;45(12):3707-10. doi: 10.1161/STROKEAHA.114.007453. Epub 2014 Oct 30.

    PMID: 25358696BACKGROUND

  • Kim BJ, Sohn H, Sun BJ, Song JK, Kang DW, Kim JS, Kwon SU. Imaging characteristics of ischemic strokes related to patent foramen ovale. Stroke. 2013 Dec;44(12):3350-6. doi: 10.1161/STROKEAHA.113.002459. Epub 2013 Sep 26.

    PMID: 24072002BACKGROUND

  • Jung JM, Lee JY, Kim HJ, Do Y, Kwon SU, Kim JS, Song JK, Kang DW. Patent foramen ovale and infarct volume in cryptogenic stroke. J Stroke Cerebrovasc Dis. 2013 Nov;22(8):1399-404. doi: 10.1016/j.jstrokecerebrovasdis.2013.04.034. Epub 2013 Jun 5.

    PMID: 23747019BACKGROUND

  • Lee JY, Song JK, Song JM, Kang DH, Yun SC, Kang DW, Kwon SU, Kim JS. Association between anatomic features of atrial septal abnormalities obtained by omni-plane transesophageal echocardiography and stroke recurrence in cryptogenic stroke patients with patent foramen ovale. Am J Cardiol. 2010 Jul 1;106(1):129-34. doi: 10.1016/j.amjcard.2010.02.025. Epub 2010 May 13.

    PMID: 20609660BACKGROUND

MeSH Terms

Conditions

Foramen Ovale, Patent

Condition Hierarchy (Ancestors)

Heart Septal Defects, AtrialHeart Septal DefectsHeart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Sun U Kwon, MD. PhD

CONTACT

82-2-3010-3960sukwon@amc.seoul.kr

Bum Joon Kim, MD PhD

CONTACT

82-2-3010-3981bj.kim@amc.seoul.kr

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 2, 2022

First Posted

February 14, 2022

Study Start

January 17, 2022

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

May 31, 2027

Last Updated

February 14, 2022

Record last verified: 2022-02

Locations

KR(1)