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NCT Number: NCT05238610

Prospective Registry of Elderly ESUS With PFO

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

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Asan Medical Center

Seoul, 05055, South Korea

Location status: Recruiting

Location contact

Sun U Kwon, MD PhD

CONTACT

[email protected]

02-3010-3960

About this study

The COACH-ELDERLY ESUS study is a multicenter, prospective, registry-based, observational study in elderly ESUS patients with high-risk PFO treated with PFO-closure + standard antiplatelet treatment or standard antiplatelet treatment only in 20 centers in Korea.

Patients will receive an insertable loop recorder (ILR) to monitor paroxysmal atrial fibrillation. In cases, which are unavailable for ILR, recurrent EKG or Holter monitoring will be done based on the clinician's decision. Based on the attending physicians' decision with a multi-disciplinary approach, patients will receive PFO-closure with standard antiplatelet treatment or standard antiplatelet treatment only.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

PFO closure

Procedure

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

Primary outcomes

  1. ischemic stroke recurrence

    Time frame: at least 1 year

    Time to occurrence of ischemic stroke after registration

Secondary outcomes

  1. MACE

    Time frame: at least 1 year

    Time to major cardiovascular event after registration

  2. Hemorrhagic stroke

    Time frame: at least 1 year

    Time to hemorrhagic stroke after registration

  3. Vascular death

    Time frame: at least 1 year

    Time to vascular death after registration

  4. Myocardial infarction

    Time frame: at least 1 year

    Time to myocardial infarction

  5. Atrial fibrillation after registration

    Time frame: at least 1 year

    Time to atrial fibrillation after registration

  6. Atrial fibrillation lasting more than 2 or 6 min after registration

    Time frame: at least 1 year

    Time to atrial fibrillation lasting more than 2 or 6 min after registration

  7. Major bleeding

    Time frame: at least 1 year

    Time to major bleeding event after registration

Study contacts

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

Bum Joon Kim, MD PhD

CONTACT

[email protected]

82-2-3010-3981

Sun U Kwon, MD. PhD

CONTACT

[email protected]

82-2-3010-3960

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Collaborators

  • National Evidence-Based Healthcare Collaborating Agency

Registry information

Official study title

Prospective Registry of Elderly Patients With ESUS to Evaluate the Role of Covert Atrial Fibrillation and Patent Foramen Ovale

Acronym: COACH_ESUS

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Feb 14, 2022
Registry last updated
Feb 14, 2022

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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