Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2025-12-25 @ 10:55 PM
Study NCT ID:
NCT04552067
Status:
COMPLETED
Last Update Posted:
2020-09-17
First Post:
2020-02-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Enoxaparin Bioequivalence Study in Acute Coronary Syndrome Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'D017984', 'term': 'Enoxaparin'}], 'ancestors': [{'id': 'D006495', 'term': 'Heparin, Low-Molecular-Weight'}, {'id': 'D006493', 'term': 'Heparin'}, {'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 172}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-10', 'studyFirstSubmitDate': '2020-02-20', 'studyFirstSubmitQcDate': '2020-09-10', 'lastUpdatePostDateStruct': {'date': '2020-09-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'anti Xa activity (UI/ml)', 'timeFrame': '4 hours', 'description': 'Compare the Anticoagulant Activity (measured in a UI per ml in a reference laboratory) of Two Formulations of Enoxaparin \\[ENOXA ® Versus LOVENOX ®\\], Conducted on Two Parallel Groups of Patients Admitted to Emergency for Acute Coronary Syndrome'}], 'secondaryOutcomes': [{'measure': 'Major Adverse Cardiac Events', 'timeFrame': '30 days', 'description': 'All major cardiovascular events'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['enoxaparin', 'Lovenox', 'ani-Xa', 'acute coronary syndrome', 'Enoxa'], 'conditions': ['Acute Coronary Syndrome']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.urgencemonastir.com', 'label': 'official website'}]}, 'descriptionModule': {'briefSummary': 'Because of their anti-Xa and ease of administration activity, the Low molecular weight heparin represent an attractive alternative to the unfractionated heparin. Several clinical trials have demonstrated that Low molecular weight heparin was more effective than Unfractionated heparin without increasing bleeding complications. Enoxaparin has been the most studied. Its use is recommended.\n\nDemonstrate that Enoxa® is comparable to that of Lovenox® in the anti-Xa activity action.', 'detailedDescription': 'Single-center randomized controlled trial, single-blind, including patient with an acute coronary syndrome confirmed, to measure the anti-Xa activity between H0 and H4.the study was done on two groups ; ENOXA® group : In this case the patient is given an injection of enoxaparin ( ENOXA® ; UNIMED Laboratories) intravenously. Curative dose (100 IU/10 kg).\n\nControl group ( LOVENOX ® ):\n\nIn this case the patient receives LOVENOX intravenous injection curative dose of 100 kg IU/10 .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age over 18 year old\n* With an acute coronary syndrome confirmed\n\nExclusion Criteria:\n\n* Age less than 18 years\n* Persistent ST segment elevation\n* Contre indication of enoxaparin and heparin in general.\n* Patient participating in another study,\n* Pregnant or nursing women\n* patients taking an anticoagulant in the last three months,\n* Patients with coagulopathy'}, 'identificationModule': {'nctId': 'NCT04552067', 'acronym': 'Enoxaparine', 'briefTitle': 'Enoxaparin Bioequivalence Study in Acute Coronary Syndrome Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Monastir'}, 'officialTitle': 'Generic and Branded Enoxaparin Bioequivalence: a Randomized Study in Acute Coronary Syndrome Patients With an In-vitro Thrombin Generation Testing Comparison', 'orgStudyIdInfo': {'id': 'Enoxaparine'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'LOVENOX', 'description': 'patients are given a curative dose of Enoxaparin (LOVENOX)', 'interventionNames': ['Drug: Lovenox']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Enoxamed', 'description': 'patients are given a curative dose of Enoxaparin (ENOXA)', 'interventionNames': ['Drug: Enoxaparin']}], 'interventions': [{'name': 'Lovenox', 'type': 'DRUG', 'description': 'patients given curative dose of Lovenox', 'armGroupLabels': ['LOVENOX']}, {'name': 'Enoxaparin', 'type': 'DRUG', 'otherNames': ['Enoxamed'], 'description': 'patients given curative dose of Enoxa', 'armGroupLabels': ['Enoxamed']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5000', 'city': 'Monastir', 'country': 'Tunisia', 'facility': 'Emergency Department of University Hospital of Monastir', 'geoPoint': {'lat': 35.77799, 'lon': 10.82617}}], 'overallOfficials': [{'name': 'Nouira Semir, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University hospital of Monastir'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Monastir', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital Fattouma Bourguiba', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of departement', 'investigatorFullName': 'Pr. Semir Nouira', 'investigatorAffiliation': 'University of Monastir'}}}}