Embolism, ParadoxicalPhase 4NCT00166257
PC-Trial: Patent Foramen Ovale and Cryptogenic Embolism
A Phase 4 study testing Percutaneous closure of patent foramen ovale and Medical antitrhombotic treatment in people with Embolism, Paradoxical and Heart Septal Defects, Atrial, run by Foundation for Cardiovascular Research, Zurich at 6 sites in 4 countries.
Trial summary
The purpose of this study is to compare two treatments strategies to prevent further attacks in patients who have suffered an stroke or occlusion of a major artery with no obvious reason other than a persistent small opening between the upper heart chambers Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Embolism, Paradoxical, Heart Septal Defects, Atrial
- What is being tested?
- Percutaneous closure of patent foramen ovale and Medical antitrhombotic treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 414 participants
- Where
- 6 sitesin 4 countries
- Study dates
- Feb 2000to May 2011
- Phase
- Phase 4
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age below 60 years
- Ischemic stroke or peripheral thromboembolism, radiologically verified
- Absence of an identifiable cause of embolism
- Echocardiographically verified patent foramen ovale
- Sufficient recovery from index event to allow independent daily activities
Who cannot join
- Any identifiable cause for thromboembolic event other than PFO
- Cardiac diseases: mural thrombus, dilated cardiomyopathy, prosthetic heart valve or mitral stenosis, endocarditis, atrial fibrillation
- Vascular system: significant atherosclerosis or dissection of the aorta, collagen vascular disease, arteritis, vasculitis
- Pre-existing neurologic disorders or intracranial disease, e.g., multiple sclerosis, arteriovenous malformations, previous hemorrhage
- Contraindications for antithrombotic or anticoagulant therapy
- Patients already on chronic anticoagulant therapy for another disease
Show all 13Show fewer
- Previous surgical or percutaneous PFO-closure
- Drug or alcohol abuse
- Pregnancy
- Septicemia or severe infectious disease
- Severe CNS disease
- No informed consent
- Foreseen difficulties with study compliance, especially the long-term follow-up
Trial locations and contacts
6 sites in 4 countries.
6 sites in 4 countries
Australia3 sites
Monash Medical Centre
Melbourne
Sir Charles Gairdner Hospital
Nedlands
Alfred Hospital
Prahan
About this study
Official title: Randomized Clinical Trial Comparing the Efficacy of Percutaneous Closure of Patent Foramen Ovale (PFO) With Medical Treatment in Patients With Cryptogenic Embolism
The purpose of this study is to compare two treatments strategies to prevent further attacks in patients who have suffered an stroke or occlusion of a major artery with no obvious reason other than a persistent small opening between the upper heart chambers
Read the detailed description
In patients who have suffered a stroke or occlusion of a large artery in another body part of unknown origin a possible cause is a small opening between the upper heart chambers (patent foramen ovale, it is called). After birth this opening closes in 75% of the population, while it persists in 25% of people. It may allow a small blood clot to pass from the veins of the legs through the heart into the brain or other parts of the body. In order to reduce the risk for a further attack we have today more therapeutic options to choose from but it is unclear which strategy have the best outcome. This study is created to compare the effect of two treatment strategies:
- Medical treatment The purpose of medical treatment is to dilute the blood to a degree, that no thrombus formation occurs. Since the opening in the heart persists, treatment is usually recommended lifelong. And patients treated with coumadin must undergo regular blood tests to ensure an adequate effect of the drug.
- Catheter closure of patent foramen ovale An alternative method developed to close the small opening in the heart utilizes catheters which are introduced in a blood vessel in the groin and from there advanced to the heart. An umbrella device is then delivered through the catheter, positioned within the small defect and released. The umbrella is overgrown with own tissue within weeks to months and closes the small defect for ever.
- Being tested
- Percutaneous closure of patent foramen ovale, Medical antitrhombotic treatment
- Keywords
- Paradoxical embolism, Patent foramen ovale,
- Medical subject headings
- Embolism, Paradoxical, Heart Septal Defects, Atrial, Foramen Ovale, Patent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous closure of patent foramen ovaleDevice
Percutaneous implantation of an AMPLATZER® PFO Occluder
Medical antitrhombotic treatmentDrug
Investigator's choice: Anticoagulation to INR 2.0 - 3.0 OR Aspirin 100-325 mg/d OR Clopidogrel 75-150 mg/d
| Study group | Role | What they receive |
|---|---|---|
| Medical antitrhombotic treatment | Active comparator | Not described Receives: Drug: Medical antitrhombotic treatment |
| Device Implant | Experimental | Percutaneous closure of patent foramen ovale Receives: Device: Percutaneous closure of patent foramen ovale |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to death (Fatal stroke, cardiovascular, non-CV),
Measured: continuosly
non-fatal cerebrovascular event,
Measured: continuosly
peripheral embolism
Measured: continuosly
Secondary outcomes (5)
New arrhythmias,
Measured: continuosly
myocardial infarction
Measured: continuosly
rehospitalization related to PFO or its treatment
Measured: continuosly
device problems
Measured: continuosly
bleeding complications
Measured: continuosly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startFeb 2000
- Primary completionFeb 2011 (estimated)
- Study completionMay 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Embolism, ParadoxicalStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 414 participants (actual)
Sponsor and investigators
- Lead sponsor
- Foundation for Cardiovascular Research, Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott Medical Devices
- Investigators
- Bernhard Meier, MD, Study chair, Dept. Cardiology, University Hospital Insel, Berne, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00166257
- Sponsor's protocol ID
- ICN98008
- Status last verified
- May 2009
- First submitted
- 9 Sep 2005
- Last updated
- 27 May 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Meier B, Kalesan B, Mattle HP, Khattab AA, Hildick-Smith D, Dudek D, Andersen G, Ibrahim R, Schuler G, Walton AS, Wahl A, Windecker S, Juni P; PC Trial Investigators. Percutaneous closure of patent foramen ovale in cryptogenic embolism. N Engl J Med. 2013 Mar 21;368(12):1083-91. doi: 10.1056/NEJMoa1211716.
PubMed 23514285Khattab AA, Windecker S, Juni P, Hildick-Smith D, Dudek D, Andersen HR, Ibrahim R, Schuler G, Walton AS, Wahl A, Mattle HP, Meier B. Randomized clinical trial comparing percutaneous closure of patent foramen ovale (PFO) using the Amplatzer PFO Occluder with medical treatment in patients with cryptogenic embolism (PC-Trial): rationale and design. Trials. 2011 Feb 28;12:56. doi: 10.1186/1745-6215-12-56.
PubMed 21356042
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial Comparing the Efficacy of Percutaneous Closure of Patent Foramen Ovale (PFO) With Medical Treatment in Patients With Cryptogenic Embolism
- ClinicalTrials.gov ID
- NCT00166257
- Acronym / sponsor ID
- ICN98008
- Keywords
- Paradoxical embolism, Patent foramen ovale,
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 414 participants (actual)
- Lead sponsor
- Foundation for Cardiovascular Research, ZurichUniversity, hospital or other
- Collaborators
- Abbott Medical Devices
- Study start
- Feb 2000
- Primary completion
- Feb 2011 (estimated)
- Study completion
- May 2011 (estimated)
- First posted
- 14 Sep 2005 (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 purpose of this study is to compare two treatments strategies to prevent further attacks in patients who have suffered an stroke or occlusion of a major artery with no obvious reason other than a persistent small opening between the upper heart chambers
Detailed description
In patients who have suffered a stroke or occlusion of a large artery in another body part of unknown origin a possible cause is a small opening between the upper heart chambers (patent foramen ovale, it is called). After birth this opening closes in 75% of the population, while it persists in 25% of people. It may allow a small blood clot to pass from the veins of the legs through the heart into the brain or other parts of the body. In order to reduce the risk for a further attack we have today more therapeutic options to choose from but it is unclear which strategy have the best outcome. This study is created to compare the effect of two treatment strategies:
- Medical treatment The purpose of medical treatment is to dilute the blood to a degree, that no thrombus formation occurs. Since the opening in the heart persists, treatment is usually recommended lifelong. And patients treated with coumadin must undergo regular blood tests to ensure an adequate effect of the drug.
- Catheter closure of patent foramen ovale An alternative method developed to close the small opening in the heart utilizes catheters which are introduced in a blood vessel in the groin and from there advanced to the heart. An umbrella device is then delivered through the catheter, positioned within the small defect and released. The umbrella is overgrown with own tissue within weeks to months and closes the small defect for ever.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medical antitrhombotic treatment | Active comparator | Drug: Medical antitrhombotic treatment |
| Device Implant | Experimental | Device: Percutaneous closure of patent foramen ovalePercutaneous closure of patent foramen ovale |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age below 60 years
- Ischemic stroke or peripheral thromboembolism, radiologically verified
- Absence of an identifiable cause of embolism
- Echocardiographically verified patent foramen ovale
- Sufficient recovery from index event to allow independent daily activities
Key exclusion criteria (13 listed)
- Any identifiable cause for thromboembolic event other than PFO
- Cardiac diseases: mural thrombus, dilated cardiomyopathy, prosthetic heart valve or mitral stenosis, endocarditis, atrial fibrillation
- Vascular system: significant atherosclerosis or dissection of the aorta, collagen vascular disease, arteritis, vasculitis
- Pre-existing neurologic disorders or intracranial disease, e.g., multiple sclerosis, arteriovenous malformations, previous hemorrhage
- Contraindications for antithrombotic or anticoagulant therapy
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 |
|---|---|---|
| Percutaneous closure of patent foramen ovalePercutaneous implantation of an AMPLATZER® PFO Occluder | Device | Device Implant |
| Medical antitrhombotic treatmentInvestigator's choice: Anticoagulation to INR 2.0 - 3.0 OR Aspirin 100-325 mg/d OR Clopidogrel 75-150 mg/d | Drug | Medical antitrhombotic treatment |
Primary outcome
Time to death (Fatal stroke, cardiovascular, non-CV),
Time frame: continuosly
non-fatal cerebrovascular event,
Time frame: continuosly
peripheral embolism
Time frame: continuosly
5 secondary outcomes
New arrhythmias,
Time frame: continuosly
myocardial infarction
Time frame: continuosly
rehospitalization related to PFO or its treatment
Time frame: continuosly
device problems
Time frame: continuosly
bleeding complications
Time frame: continuosly
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2009.
- Derived from this study: PubMed 23514285Meier B, Kalesan B, Mattle HP, Khattab AA, Hildick-Smith D, Dudek D, Andersen G, Ibrahim R, Schuler G, Walton AS, Wahl A, Windecker S, Juni P; PC Trial Investigators. Percutaneous closure of patent foramen ovale in cryptogenic embolism. N Engl J Med. 2013 Mar 21;368(12):1083-91. doi: 10.1056/NEJMoa1211716.
- Derived from this study: PubMed 21356042Khattab AA, Windecker S, Juni P, Hildick-Smith D, Dudek D, Andersen HR, Ibrahim R, Schuler G, Walton AS, Wahl A, Mattle HP, Meier B. Randomized clinical trial comparing percutaneous closure of patent foramen ovale (PFO) using the Amplatzer PFO Occluder with medical treatment in patients with cryptogenic embolism (PC-Trial): rationale and design. Trials. 2011 Feb 28;12:56. doi: 10.1186/1745-6215-12-56.
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.
Bernhard Meier, MD study chair
Dept. Cardiology, University Hospital Insel, Berne, Switzerland
6 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Percutaneous closure of patent foramen ovale and Medical antitrhombotic treatment in people with Embolism, Paradoxical and Heart Septal Defects, Atrial, run by Foundation for Cardiovascular Research, Zurich at 6 sites in 4 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 5 inclusion and 13 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 27 May 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Australia, Austria, Belgium, Switzerland. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to death (Fatal stroke, cardiovascular, non-CV), (time frame: continuosly). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00166257, which also lists 2 linked publications.
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 27 May 2009.