International PFO Consortium

Stroke Clinical Trial

Official title:

Secondary Stroke Prevention In Patients With Patent Foramen Ovale: International PFO Consortium

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00859885
• Other study ID #: 117/08
• Status: Recruiting
• Phase: N/A
• First received: March 6, 2009
• Last updated: December 11, 2017
• Start date: September 8, 2008
• Est. completion date: December 2021

Study information

• Verified date: December 2017
• Source: University Hospital Inselspital, Berne
• Contact: Krassen Nedeltchev, MD
• Phone: +41 62 838 66 75
• Email: Krassen.Nedeltchev[@]ksa.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The prevalence of patent foramen ovale (PFO) is about 25% in the general population and approximately 40% in patients who have ischemic stroke of unknown cause (cryptogenic stroke). Given the large number of asymptomatic patients, no primary prevention is currently recommended. On the contrary, secondary prevention is very important. Prospective studies have shown that antithrombotic treatment (ATT) with aspirin or warfarin appears to negate the risk of recurrent stroke associated with a PFO. Patients with spontaneous or large right-to-left shunts (RLS), those with a coinciding atrial septal aneurysm (ASA) or multiple ischemic events prior to the PFO diagnosis may still be at increased risk of stroke recurrence despite ATT. Percutaneous device closure (PDC) is a challenging alternative to ATT. Several studies reported 0% to 3.4% annual recurrence rates of stroke or TIA in patients treated by PDC. To date, there is no data from randomized controlled trials (RCT) comparing the risk of stroke recurrence after PDC with that under ATT only. The results from ongoing RCTs are not to be awaited in the near future, mainly due to low enrolment and event rates. Alternative data-gathering strategies such as multicenter registries are needed to overcome the low recruitment rates. The aim of the present study is to compare the risk of recurrent stroke and TIA in patients with PFO and otherwise unexplained stroke who undergo PDC or receive ATT.

Description:

Background

The prevalence of patent foramen ovale (PFO) is about 25% in the general population and approximately 40% in patients who have ischemic stroke of unknown cause (cryptogenic stroke). Given the large number of asymptomatic patients, no primary prevention is currently recommended. On the contrary, secondary prevention is very important. Prospective studies have shown that antithrombotic treatment (ATT) with aspirin or warfarin appears to negate the risk of recurrent stroke associated with a PFO. Patients with spontaneous or large right-to-left shunts (RLS), those with a coinciding atrial septal aneurysm (ASA) or multiple ischemic events prior to the PFO diagnosis may still be at increased risk of stroke recurrence despite ATT. Percutaneous device closure (PDC) is a challenging alternative to ATT. Several studies reported 0% to 3.4% annual recurrence rates of stroke or TIA in patients treated by PDC. To date, there is no data from randomized controlled trials (RCT) comparing the risk of stroke recurrence after PDC with that under ATT only. The results from ongoing RCTs are not to be awaited in the near future, mainly due to low enrolment and event rates. Even if RCTs are completed successfully, statistical differences may remain undetected with the planned sample sizes. Alternative data-gathering strategies such as multicenter registries are needed to overcome the low recruitment rates.

Objective

1) To compare the risk of recurrent stroke and TIA in patients aged ≤ 55 years with PFO and otherwise unexplained stroke who undergo PDC or receive ATT only; 2) To assess the etiological role of PFO for stroke/TIA in patients aged > 55 years; 3) To assess the risk of recurrent stroke/TIA in "high-risk" PFO patients (i.e. those with spontaneous (at rest) or large RLS, coinciding ASA, or multiple previous cerebrovascular events).

Methods

Multicenter prospective non-randomized study with scheduled 3-years follow-up of patients with PFO and ischemic stroke or TIA. Participating centers: Swiss University Hospitals of Basel, Bern, Geneva, Lausanne and Zurich, the Cantonal Hospital of Aarau, the Triemli Hospital, the Alfried-Krupp Krankenhaus of Essen, the University Hospital of Essen, the Klinikum Worms gGmbH, Tufts Medical Center, Baystate Medical Center, the East Medical Center Tyler, and the University Hospital of Leuven.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age > 18 years

• Diagnosis of PFO established by transesophageal echocardiography (TEE)

• Ischemic stroke or transient ischemic attack within the previous 6 months

Exclusion Criteria

• Non-vascular origin of the neurological symptoms after brain imaging (CT scan or MRI)

• Comorbid condition that would interfere with the study

• Pregnancy

• History of intracranial bleeding, confirmed arterio-venous malformation, aneurysm or uncontrolled coagulopathy

• Contraindications for TEE, echocardiographic or iodine contrast media

Related Conditions & MeSH terms

• Foramen Ovale, Patent
• Ischemic Attack, Transient
• Stroke
• Transient Ischemic Attack

Intervention

Drug:
• Antithrombotic treatment
antiplatelets, anticoagulants

Device:
• percutaneous device closure of PFO
umbrella device for PFO closure

Locations

Country	Name	City	State
Belgium	University Hospital Gent	Gent
Belgium	Leuven University Hospital	Leuven
Germany	Alfried Krupp Hospital	Essen
Germany	Essen University Hospital	Essen
Germany	Ammerland Klinik GmbH	Westerstede
Germany	Klinikum Worms gGmbH	Worms
Italy	Arcispedale Santa Maria Nuova, Department of Neurology, ASMN IRCCS	Reggio Emilia
Spain	University Hospital Doctor Josep Trueta	Girona
Switzerland	Cantonal Hospital of Aarau	Aarau
Switzerland	Basel University Hospital	Basel
Switzerland	Department of Neurology, Bern University Hospital, Bern	Bern
Switzerland	Geneva University Hospital	Geneva
Switzerland	Lausanne University Hospital	Lausanne
Switzerland	Zürich Triemli Hospital	Zürich
Switzerland	Zürich University Hospital	Zürich
United States	Tufts Medical Center	Boston	Massachusetts
United States	Baystate Medical Center	Springfield	Massachusetts
United States	East Medical Center	Tyler	Texas

Sponsors (17)

Lead Sponsor

Collaborator

University Hospital Inselspital, Berne

Alfried-Krupp Krankenhaus of Essen, Germany, Ammerland Klinik GmbH, Westerstede, Germany, Arcispedale Santa Maria Nuova-IRCCS, Baystate Medical Center, Cantonal Hospital of Aarau, Switzerland, East Medical Center Tyler, Texas, Klinikum Worms, Triemli Hospital, Tufts Medical Center, Universitaire Ziekenhuizen Leuven, University Hospital, Basel, Switzerland, University Hospital, Essen, University Hospital, Geneva, University Hospital, Ghent, University Hospital, Zürich, University of Lausanne Hospitals

Countries where clinical trial is conducted

United States,  Belgium,  Germany,  Italy,  Spain,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	proportion of patients free of any stroke (including fatal stroke) or TIA		3 years
Secondary	influence of gender, age, spontaneous or large shunt, coincidence of an atrial septum aneurysma		3 years
Secondary	influence of competitive causes of stroke		3 years
Secondary	frequency of residual shunt, (in)correct device position, need for implantation of second device and periprocedural complications		30 days and 6 months

External Links

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