StrokeNCT00859885
International PFO Consortium
An observational study of Stroke and Transient Ischemic Attack, run by Insel Gruppe AG, University Hospital Bern at 18 sites in 6 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Transient Ischemic Attack
- What is being tested?
- Antithrombotic treatment and percutaneous device closure of PFO
- Type of treatment
- Medical device
- How many people
- 1,500 participants
- Where
- 18 sitesin 6 countries
- Study dates
- 8 Sep 2008to Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with ischemic stroke or transient ischemic attacks, in whom a patent foramen ovale has been diagnosed by means of a transesophageal echocardiography
Who may be able to join
- Age > 18 years
- Diagnosis of PFO established by transesophageal echocardiography (TEE)
- Ischemic stroke or transient ischemic attack within the previous 6 months
Who cannot join
- 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
Trial locations and contacts
18 sites in 6 countries.
18 sites in 6 countries
Switzerland7 sites, 5 recruiting
- Recruiting
Cantonal Hospital of Aarau
Aarau, 5001
- Completed
Basel University Hospital
Basel, 4031
- Recruiting
Department of Neurology, Bern University Hospital, Bern
Bern, 3010
Marie-Luise Mono, +41316320743, marie-luise.mono@insel.ch
Marie-Luise Mono, MD
- Recruiting
Geneva University Hospital
Geneva, 1211
- Recruiting
Lausanne University Hospital
Lausanne, 1011
- Completed
Zürich Triemli Hospital
Zurich, 8063
- Recruiting
Zürich University Hospital
Zurich, 8091
Germany4 sites, 4 recruiting
- Recruiting
Alfried Krupp Hospital
Essen, 45117
- Recruiting
Essen University Hospital
Essen, 45147
- Recruiting
Ammerland Klinik GmbH
Westerstede, 26655
Andreas Müller-Eichelberg, MD
- Recruiting
Klinikum Worms gGmbH
Worms, 67550
United States3 sites, 2 recruiting
- Recruiting
Tufts Medical Center
Boston, Massachusetts, 02111
- Completed
Baystate Medical Center
Springfield, Massachusetts, 01199
- Recruiting
East Medical Center
Tyler, Texas, 75710
Belgium2 sites, 2 recruiting
- Recruiting
University Hospital Gent
Ghent, 9000
Dimitri Hemelsoet, MD
- Recruiting
Leuven University Hospital
Leuven, 3000
Italy1 site, 1 recruiting
- Recruiting
Arcispedale Santa Maria Nuova, Department of Neurology, ASMN IRCCS
Reggio Emilia, 42123
Spain1 site, 1 recruiting
- Recruiting
University Hospital Doctor Josep Trueta
Girona, 17707
Joaquín Serena, MD
About this study
Official title: 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.
Read the detailed 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
- 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.
- Conditions
- Stroke, Transient Ischemic Attack
- Being tested
- Antithrombotic treatment, percutaneous device closure of PFO
- Keywords
- patent foramen ovale, ischemic stroke, transient ischemic attack, secondary prevention, medical treatment, percutaneous device closure
- Medical subject headings
- Stroke, Ischemic Attack, Transient, Foramen Ovale, Patent, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antithrombotic treatmentDrug
Also called aspirin
antiplatelets, anticoagulants
percutaneous device closure of PFODevice
Also called clopidogrel
umbrella device for PFO closure
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients who receive antithrombotic treatment only Receives: Drug: Antithrombotic treatment | |
| 2 | Patients who undergo percutaneous device closure Receives: Device: percutaneous device closure of PFO |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of patients free of any stroke (including fatal stroke) or TIA
Measured: 3 years
Secondary outcomes (3)
influence of gender, age, spontaneous or large shunt, coincidence of an atrial septum aneurysma
Measured: 3 years
influence of competitive causes of stroke
Measured: 3 years
frequency of residual shunt, (in)correct device position, need for implantation of second device and periprocedural complications
Measured: 30 days and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2009 (estimated)
- Study start8 Sep 2008
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- 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, Tufts Medical Center, Baystate Medical Center, East Medical Center Tyler, Texas, Universitaire Ziekenhuizen KU Leuven, Ammerland Klinik GmbH, Westerstede, Germany, University Hospital, Ghent, Azienda USL Reggio Emilia - IRCCS
- Investigators
- Krassen Nedeltchev, MD, Principal investigator, Kantonsspital AarauMarie-Luise Mono, MD, Principal investigator, Dep. of Neurology, Bern University Hospital, BernMarcel Arnold, MD, Study director, University of Bern, Inselspital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00859885
- Sponsor's protocol ID
- 117/08
- Status last verified
- Dec 2017
- First submitted
- 6 Mar 2009
- Last updated
- 12 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Secondary Stroke Prevention In Patients With Patent Foramen Ovale: International PFO Consortium
- ClinicalTrials.gov ID
- NCT00859885
- Acronym / sponsor ID
- 117/08
- Conditions
- Stroke, Transient Ischemic Attack
- Keywords
- patent foramen ovale, ischemic stroke, transient ischemic attack, secondary prevention, medical treatment, percutaneous device closure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- 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, Tufts Medical Center, Baystate Medical Center, East Medical Center Tyler, Texas, Universitaire Ziekenhuizen KU Leuven, Ammerland Klinik GmbH, Westerstede, Germany, University Hospital, Ghent, Azienda USL Reggio Emilia - IRCCS
- Study start
- 8 Sep 2008 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 11 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Drug: Antithrombotic treatmentPatients who receive antithrombotic treatment only |
| 2 | – | Device: percutaneous device closure of PFOPatients who undergo percutaneous device closure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with ischemic stroke or transient ischemic attacks, in whom a patent foramen ovale has been diagnosed by means of a transesophageal echocardiography
Key inclusion criteria (3 listed)
- Age > 18 years
- Diagnosis of PFO established by transesophageal echocardiography (TEE)
- Ischemic stroke or transient ischemic attack within the previous 6 months
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antithrombotic treatmentAlso: aspirinantiplatelets, anticoagulants | Drug | 1 |
| percutaneous device closure of PFOAlso: clopidogrelumbrella device for PFO closure | Device | 2 |
Primary outcome
proportion of patients free of any stroke (including fatal stroke) or TIA
Time frame: 3 years
3 secondary outcomes
influence of gender, age, spontaneous or large shunt, coincidence of an atrial septum aneurysma
Time frame: 3 years
influence of competitive causes of stroke
Time frame: 3 years
frequency of residual shunt, (in)correct device position, need for implantation of second device and periprocedural complications
Time frame: 30 days and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2017.
Related trials for Stroke
Recruiting
Delay AvoIding Primary Evaluation for ThRombectomy of Acute StrokE Patients With Large Vessel OCclusion in the Angiography SuiTe
Stroke, Acute
RecruitingPhase 4
Xeomin® and Gait Related Mobility After Stroke
Stroke
RecruitingObservational study
Implementing Transcranial Direct Current Stimulation in a Rehabilitation Setting
Aphasia, Stroke
Not yet recruiting
EEG Feedback-Based Vagus Nerve Stimulation for Post-Stroke Dysphagia
Ischemic Stroke, Post-stroke Dysphagia
RecruitingObservational study
Development and Validation of Risk Prediction Models for Stroke and Cognitive Impairment in Moyamoya Disease and Moyamoya Syndrome
Moyamoya Disease, Moyamoya Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Krassen Nedeltchev, MD principal investigator
Kantonsspital Aarau
Marie-Luise Mono, MD principal investigator
Dep. of Neurology, Bern University Hospital, Bern
Marcel Arnold, MD study director
University of Bern, Inselspital
18 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Transient Ischemic Attack, run by Insel Gruppe AG, University Hospital Bern at 18 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Switzerland, Germany, United States, Belgium, Italy and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Krassen Nedeltchev, MD (+41 62 838 66 75, Krassen.Nedeltchev@ksa.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
proportion of patients free of any stroke (including fatal stroke) or TIA (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2017.