International PFO Consortium

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by University Hospital Inselspital, Berne
Sponsor:
Collaborators:
University Hospital, Basel, Switzerland
University of Lausanne Hospitals
University Hospital, Geneva
University Hospital, Zürich
Triemli Hospital
Cantonal Hospital of Aarau, Switzerland
Alfried-Krupp Krankenhaus of Essen, Germany
University Hospital, Essen
Klinikum Worms gGmbH, Germany
Tufts Medical Center
Baystate Medical Center
East Medical Center Tyler, Texas
Universitaire Ziekenhuizen Leuven
Ammerland Klinik GmbH, Westerstede, Germany
University Hospital, Ghent
Arcispedale Santa Maria Nuova-IRCCS
Information provided by:
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT00859885
First received: March 6, 2009
Last updated: September 8, 2014
Last verified: September 2014

March 6, 2009
September 8, 2014
January 2009
December 2014   (final data collection date for primary outcome measure)
proportion of patients free of any stroke (including fatal stroke) or TIA [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00859885 on ClinicalTrials.gov Archive Site
  • influence of gender, age, spontaneous or large shunt, coincidence of an atrial septum aneurysma [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • influence of competitive causes of stroke [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • frequency of residual shunt, (in)correct device position, need for implantation of second device and periprocedural complications [ Time Frame: 30 days and 6 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
International PFO Consortium
Secondary Stroke Prevention In Patients With Patent Foramen Ovale: International PFO Consortium

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patients with ischemic stroke or transient ischemic attacks, in whom a patent foramen ovale has been diagnosed by means of a transesophageal echocardiography

  • Stroke
  • Transient Ischemic Attack
  • Drug: Antithrombotic treatment
    antiplatelets, anticoagulants
    Other Name: aspirin
  • Device: percutaneous device closure of PFO
    umbrella device for PFO closure
    Other Name: clopidogrel
  • 1
    Patients who receive antithrombotic treatment only
    Intervention: Drug: Antithrombotic treatment
  • 2
    Patients who undergo percutaneous device closure
    Intervention: Device: percutaneous device closure of PFO
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1500
June 2015
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Krassen Nedeltchev, MD +41 62 838 66 75 Krassen.Nedeltchev@ksa.ch
Contact: Marie-Luise Mono, MD +41316320743 marie-luise.mono@insel.ch
United States,   Belgium,   Germany,   Italy,   Spain,   Switzerland
 
NCT00859885
117/08
No
Prof. Dr. med. Krassen Nedeltchev, University of Bern and Triemli Hospital Zurich
University Hospital Inselspital, Berne
  • University Hospital, Basel, Switzerland
  • University of Lausanne Hospitals
  • University Hospital, Geneva
  • University Hospital, Zürich
  • Triemli Hospital
  • Cantonal Hospital of Aarau, Switzerland
  • Alfried-Krupp Krankenhaus of Essen, Germany
  • University Hospital, Essen
  • Klinikum Worms gGmbH, Germany
  • Tufts Medical Center
  • Baystate Medical Center
  • East Medical Center Tyler, Texas
  • Universitaire Ziekenhuizen Leuven
  • Ammerland Klinik GmbH, Westerstede, Germany
  • University Hospital, Ghent
  • Arcispedale Santa Maria Nuova-IRCCS
Principal Investigator: Krassen Nedeltchev, MD Kantonsspital Aarau
Principal Investigator: Marie-Luise Mono, MD Dep. of Neurology, Bern University Hospital, Bern
Study Director: Marcel Arnold, MD University of Bern, Inselspital
University Hospital Inselspital, Berne
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP