Ignite Creation Date:
2025-12-24 @ 6:48 PM
Ignite Modification Date:
2026-01-04 @ 6:20 AM
Study NCT ID:
NCT00166257
Status:
UNKNOWN
Last Update Posted:
2009-05-27
First Post:
2005-09-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PC-Trial: Patent Foramen Ovale and Cryptogenic Embolism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019320', 'term': 'Embolism, Paradoxical'}, {'id': 'D006344', 'term': 'Heart Septal Defects, Atrial'}, {'id': 'D054092', 'term': 'Foramen Ovale, Patent'}], 'ancestors': [{'id': 'D013923', 'term': 'Thromboembolism'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006343', 'term': 'Heart Septal Defects'}, {'id': 'D006330', 'term': 'Heart Defects, Congenital'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 414}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2000-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-05', 'completionDateStruct': {'date': '2011-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-05-26', 'studyFirstSubmitDate': '2005-09-09', 'studyFirstSubmitQcDate': '2005-09-09', 'lastUpdatePostDateStruct': {'date': '2009-05-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to death (Fatal stroke, cardiovascular, non-CV),', 'timeFrame': 'continuosly'}, {'measure': 'non-fatal cerebrovascular event,', 'timeFrame': 'continuosly'}, {'measure': 'peripheral embolism', 'timeFrame': 'continuosly'}], 'secondaryOutcomes': [{'measure': 'New arrhythmias,', 'timeFrame': 'continuosly'}, {'measure': 'myocardial infarction', 'timeFrame': 'continuosly'}, {'measure': 'rehospitalization related to PFO or its treatment', 'timeFrame': 'continuosly'}, {'measure': 'device problems', 'timeFrame': 'continuosly'}, {'measure': 'bleeding complications', 'timeFrame': 'continuosly'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Paradoxical embolism, Patent foramen ovale,'], 'conditions': ['Embolism, Paradoxical', 'Heart Septal Defects, Atrial']}, 'referencesModule': {'references': [{'pmid': '23514285', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '21356042', 'type': 'DERIVED', 'citation': 'Khattab 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.'}]}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': '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:\n\n1. 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.\n2. 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age below 60 years\n* Ischemic stroke or peripheral thromboembolism, radiologically verified\n* Absence of an identifiable cause of embolism\n* Echocardiographically verified patent foramen ovale\n* Sufficient recovery from index event to allow independent daily activities\n\nExclusion Criteria:\n\n* Any identifiable cause for thromboembolic event other than PFO\n* Cardiac diseases: mural thrombus, dilated cardiomyopathy, prosthetic heart valve or mitral stenosis, endocarditis, atrial fibrillation\n* Vascular system: significant atherosclerosis or dissection of the aorta, collagen vascular disease, arteritis, vasculitis\n* Pre-existing neurologic disorders or intracranial disease, e.g., multiple sclerosis, arteriovenous malformations, previous hemorrhage\n* Contraindications for antithrombotic or anticoagulant therapy\n* Patients already on chronic anticoagulant therapy for another disease\n* Previous surgical or percutaneous PFO-closure\n* Drug or alcohol abuse\n* Pregnancy\n* Septicemia or severe infectious disease\n* Severe CNS disease\n* No informed consent\n* Foreseen difficulties with study compliance, especially the long-term follow-up'}, 'identificationModule': {'nctId': 'NCT00166257', 'briefTitle': 'PC-Trial: Patent Foramen Ovale and Cryptogenic Embolism', 'organization': {'class': 'OTHER', 'fullName': 'Foundation for Cardiovascular Research, Zurich'}, 'officialTitle': 'Randomized Clinical Trial Comparing the Efficacy of Percutaneous Closure of Patent Foramen Ovale (PFO) With Medical Treatment in Patients With Cryptogenic Embolism', 'orgStudyIdInfo': {'id': 'ICN98008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Medical antitrhombotic treatment', 'interventionNames': ['Drug: Medical antitrhombotic treatment']}, {'type': 'EXPERIMENTAL', 'label': 'Device Implant', 'description': 'Percutaneous closure of patent foramen ovale', 'interventionNames': ['Device: Percutaneous closure of patent foramen ovale']}], 'interventions': [{'name': 'Percutaneous closure of patent foramen ovale', 'type': 'DEVICE', 'description': 'Percutaneous implantation of an AMPLATZER® PFO Occluder', 'armGroupLabels': ['Device Implant']}, {'name': 'Medical antitrhombotic treatment', 'type': 'DRUG', 'description': "Investigator's choice: Anticoagulation to INR 2.0 - 3.0 OR Aspirin 100-325 mg/d OR Clopidogrel 75-150 mg/d", 'armGroupLabels': ['Medical antitrhombotic treatment']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Melbourne', 'country': 'Australia', 'facility': 'Monash Medical Centre', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'city': 'Nedlands', 'country': 'Australia', 'facility': 'Sir Charles Gairdner Hospital', 'geoPoint': {'lat': -31.98184, 'lon': 115.8073}}, {'city': 'Prahan', 'country': 'Australia', 'facility': 'Alfred Hospital'}, {'zip': '1090', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Universitätsklinik für Innere Medizin II', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '8000', 'city': 'Bruges', 'country': 'Belgium', 'facility': 'A.Z. Sint-Jan AV', 'geoPoint': {'lat': 51.20892, 'lon': 3.22424}}, {'city': 'Bern', 'country': 'Switzerland', 'facility': 'University Hospital / Inselspital', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}], 'overallOfficials': [{'name': 'Bernhard Meier, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Dept. Cardiology, University Hospital Insel, Berne, Switzerland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Foundation for Cardiovascular Research, Zurich', 'class': 'OTHER'}, 'collaborators': [{'name': 'Abbott Medical Devices', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Meier, Bernhard, MD, Professor of Cardiology,', 'oldOrganization': 'University of Berne, Switzerland'}}}}