Ignite Creation Date:
2025-12-24 @ 4:49 PM
Ignite Modification Date:
2025-12-28 @ 11:12 AM
Study NCT ID:
NCT00997750
Status:
COMPLETED
Last Update Posted:
2009-10-19
First Post:
2009-10-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Lornoxicam in Patients With Acute Coronary Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'releaseDate': '2011-08-11', 'unreleaseDateUnknown': True}], 'estimatedResultsFirstSubmitDate': '2011-08-11'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D054058', 'term': 'Acute Coronary Syndrome'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C059451', 'term': 'lornoxicam'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 85}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-10', 'completionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-10-18', 'studyFirstSubmitDate': '2009-10-18', 'studyFirstSubmitQcDate': '2009-10-18', 'lastUpdatePostDateStruct': {'date': '2009-10-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-10-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'All Cardiovascular events (cardiovascular dearth+nonfatal miocardial infarction+unstable angina)', 'timeFrame': 'six months'}], 'secondaryOutcomes': [{'measure': 'Noncardiovascular death, Gastrointestinal bleeding', 'timeFrame': 'six months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['ACS', 'Acute Coronary Syndrome', 'NSAID', 'Lornoxicam', 'Xefocam'], 'conditions': ['Acute Coronary Syndrome']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Lomakin N.V., Gruzdev A.K. Cardiovascular risks of cyclooxygenase inhibitors (data review). Kardiol serdecno-sosud hir #1:28-36, 2009 (http://www.mediasphera.ru/journals/cardsurg/530/eng/8095/)'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether nonsteroidal antiinflammatory drug lornoxicam in combination with low dose aspirin (100mg/day) is effective and safe in patients with Acute Coronary Syndrome without persistent ST-segment elevation.', 'detailedDescription': 'Nonsteroidal Antiinflammatory drugs (NSAIDs) are the most frequently prescribed drugs in the world. There are a lot of controversial information published during recent years about NSAID cardiosafety. It is still unclear do NSAIDs develop cardioprotective or cardiotoxic effects in acute and chronic heart disease patients. Aim of the study was to investigate safety and efficacy of Lornoxicam, nonselective COX-inhibitor, in patients with acute coronary syndrome without ST-segment elevation (NSTEACS) and to evaluate the influence of Lornoxicam on C-reactive protein (CRP) and IL-6, IL-10 levels.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Unstable angina verified during first 48 hours after admitting to the hospital or\n2. Acute Miocardial infarction without St-segment elevation verified during first 48 hours after admitting to the hospital\n\nExclusion Criteria:\n\n1. High risk of bleeding of any location\n2. Any kind of acute and active inflammatory process (excluding acute coronary syndrome)\n3. Aspirin or NSAID Intolerability\n4. No informed consent\n5. Acute peptic stomach or duodenum ulcer\n6. Acute or chronic renal failure (serum creatinin \\>300 mmol/l)\n7. Acute cerebrovascular bleeding'}, 'identificationModule': {'nctId': 'NCT00997750', 'acronym': 'PLEA', 'briefTitle': 'Efficacy and Safety of Lornoxicam in Patients With Acute Coronary Syndrome', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Central Clinical Hospital w/Outpatient Health Center of Business Administration for the President of Russian Federation'}, 'officialTitle': 'Prospective Randomized Double-center Study of Nonsteroidal Antinflammatory Drug Lornoxicam in Patients With Acute Coronary Syndrome Without Persistent ST- Segment Elevation', 'orgStudyIdInfo': {'id': 'AB-CCH-51'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lornoxicam', 'description': 'Lornoxicam 8mg/day and 12mg/day for 15 days', 'interventionNames': ['Drug: Lornoxicam']}], 'interventions': [{'name': 'Lornoxicam', 'type': 'DRUG', 'otherNames': ['Xefocam'], 'description': 'lornoxicam 8mg/day and 12mg/day for 15 days', 'armGroupLabels': ['Lornoxicam']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Moscow', 'country': 'Russia', 'facility': 'Central Clinical Hospital of Presidential Department Of Russian Federation', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}], 'overallOfficials': [{'name': 'Alexei K Gruzdev, Prof', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Cardiology, Central Clinical Hospital of Presidential Administration of Russian Federation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Clinical Hospital w/Outpatient Health Center of Business Administration for the President of Russian Federation', 'class': 'OTHER_GOV'}, 'responsibleParty': {'oldNameTitle': 'Dr Nikita Lomakin', 'oldOrganization': 'Central Clinical Hospital of President Department of Russian Federation'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2011-08-11', 'type': 'RELEASE'}, {'type': 'UNRELEASE', 'dateUnknown': True}], 'unpostedResponsibleParty': 'Dr Nikita Lomakin, Cardiologist, Phd, Cardiology Department, Intensive Cardiac Unit, Central Clinical Hospital w/Outpatient Health Center of Business Administration for the President of Russian Federation'}}}}