Ignite Creation Date:
2025-12-24 @ 10:21 PM
Ignite Modification Date:
2026-02-25 @ 5:34 PM
Study NCT ID:
NCT02238535
Status:
UNKNOWN
Last Update Posted:
2015-09-23
First Post:
2014-09-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of Ventavis in Patients With Postembolic Residual Pulmonary Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D016285', 'term': 'Iloprost'}, {'id': 'D014859', 'term': 'Warfarin'}], 'ancestors': [{'id': 'D011465', 'term': 'Prostaglandins, Synthetic'}, {'id': 'D011453', 'term': 'Prostaglandins'}, {'id': 'D015777', 'term': 'Eicosanoids'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D012898', 'term': 'Autacoids'}, {'id': 'D018836', 'term': 'Inflammation Mediators'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D015110', 'term': '4-Hydroxycoumarins'}, {'id': 'D003374', 'term': 'Coumarins'}, {'id': 'D001578', 'term': 'Benzopyrans'}, {'id': 'D011714', 'term': 'Pyrans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2016-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-09-21', 'studyFirstSubmitDate': '2014-09-03', 'studyFirstSubmitQcDate': '2014-09-11', 'lastUpdatePostDateStruct': {'date': '2015-09-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-09-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pulmonary hypertension', 'timeFrame': '6 months', 'description': 'The average pressure in the pulmonary artery trunk (according to direct tensiometry before Ventavis therapy, after the therapy according to transthoracic echocardiography and six months after discharge (transthoracic echocardiography).'}], 'secondaryOutcomes': [{'measure': 'Number of deaths', 'timeFrame': '6 months'}, {'measure': 'Number of recurrent pulmonary embolisms', 'timeFrame': '6 months'}, {'measure': 'Number of venous thromboembolisms', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Residual Pulmonary Hypertension']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://meshalkin.ru', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'To assess the effectiveness of the synthetic analogue of prostacyclin in postembolic residual pulmonary hypertension.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with pulmonary embolism after undergone surgical treatment (intravascular thrombolysis, catheter thrombus fragmentation)\n* Patients with preserved thromboembolism in the pulmonary circulation system and mean pressure in the pulmonary artery of more than 25 mm Hg\n\nExclusion Criteria:\n\n* Patient did not sign the informed consent.\n* Mean pulmonary artery pressure after surgical treatment less than 25 mm Hg\n* Age above 75 years.\n* Patients with an increased risk of bleeding - including gastric ulcer and 12 duodenal ulcer in acute, hemorrhagic stroke.\n* Severe coronary artery disease (unstable angina, myocardial infarction within the last 6 months).\n* Acute heart failure or CHF IV in NYHA.\n* Severe arrhythmias.\n* Pregnancy, lactation.\n* The presence of severe diseases of other organ systems that may result in death during the first year after surgery.'}, 'identificationModule': {'nctId': 'NCT02238535', 'briefTitle': 'Use of Ventavis in Patients With Postembolic Residual Pulmonary Hypertension', 'organization': {'class': 'NETWORK', 'fullName': 'Meshalkin Research Institute of Pathology of Circulation'}, 'officialTitle': 'Use of Ventavis in Patients With Postembolic Residual Pulmonary Hypertension', 'orgStudyIdInfo': {'id': 'Ventavis_PRPH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Ventavis + Warfarin', 'description': 'Patients in this group will receive drug treatment - ventavis (2,0 ml - 6 time per day - during 5 days). Warfarin - INR=2,0-3,0', 'interventionNames': ['Drug: Ventavis', 'Drug: Warfarin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Warfarin', 'description': 'Patients in this group will receive drug treatment according to up-to-date guidelines (Warfarin - INR=2,0-3,0)', 'interventionNames': ['Drug: Warfarin']}], 'interventions': [{'name': 'Ventavis', 'type': 'DRUG', 'armGroupLabels': ['Ventavis + Warfarin']}, {'name': 'Warfarin', 'type': 'DRUG', 'armGroupLabels': ['Ventavis + Warfarin', 'Warfarin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '630055', 'city': 'Novosibirsk', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Yulia Klevanets, MD', 'role': 'CONTACT', 'email': 'klevanetc@yandex.ru', 'phone': '+79139443607'}], 'facility': 'State Research Institute of Circulation Pathology', 'geoPoint': {'lat': 55.02259, 'lon': 82.93175}}], 'centralContacts': [{'name': 'Yulia Klevanets, MD', 'role': 'CONTACT', 'email': 'klevanetc@yandex.ru', 'phone': '+79139443607'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Meshalkin Research Institute of Pathology of Circulation', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}