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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00859885
Other study ID # 117/08
Secondary ID
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
Health authority
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

Study Design


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
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