Prospective Registry of Elderly ESUS With PFO (COACH_ESUS)

February 11, 2022 updated by: Sun U. Kwon, Asan Medical Center

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Anticipated)

1200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Elderly ESUS patients

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
PFO-closure will be performed after 3-6 month of observation and monitoring for paroxysmal atrial fibrillation
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ischemic stroke recurrence
Time Frame: at least 1 year
Time to occurrence of ischemic stroke after registration
at least 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MACE
Time Frame: at least 1 year
Time to major cardiovascular event after registration
at least 1 year
Hemorrhagic stroke
Time Frame: at least 1 year
Time to hemorrhagic stroke after registration
at least 1 year
Vascular death
Time Frame: at least 1 year
Time to vascular death after registration
at least 1 year
Myocardial infarction
Time Frame: at least 1 year
Time to myocardial infarction
at least 1 year
Atrial fibrillation after registration
Time Frame: at least 1 year
Time to atrial fibrillation after registration
at least 1 year
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
at least 1 year
Major bleeding
Time Frame: at least 1 year
Time to major bleeding event after registration
at least 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asan Medical Center

Collaborators

National Evidence-Based Healthcare Collaborating Agency

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 17, 2022

Primary Completion (Anticipated)

May 31, 2026

Study Completion (Anticipated)

May 31, 2027

Study Registration Dates

First Submitted

February 2, 2022

First Submitted That Met QC Criteria

February 11, 2022

First Posted (Actual)

February 14, 2022

Study Record Updates

Last Update Posted (Actual)

February 14, 2022

Last Update Submitted That Met QC Criteria

February 11, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COACH_ELDERLY_ESUS_NECA_2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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