Ignite Creation Date:
2025-12-24 @ 3:57 PM
Ignite Modification Date:
2026-04-14 @ 1:05 PM
Study NCT ID:
NCT03158792
Status:
COMPLETED
Last Update Posted:
2017-09-11
First Post:
2017-04-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Enoxaparin 20mg Versus 30mg Subcutaneously Once Daily in Elderly Patients With Impaired Renal Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054556', 'term': 'Venous Thromboembolism'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}], 'ancestors': [{'id': 'D013923', 'term': 'Thromboembolism'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital 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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2017-07-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-08', 'studyFirstSubmitDate': '2017-04-09', 'studyFirstSubmitQcDate': '2017-05-16', 'lastUpdatePostDateStruct': {'date': '2017-09-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-07-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Peak anti-Xa levels', 'timeFrame': 'Day 3 of thromboprophylaxis', 'description': 'Peak anti-Xa levels, drawn 4 hours after the enoxaparin dose is given'}], 'secondaryOutcomes': [{'measure': 'Trough anti-xa levels', 'timeFrame': 'Day 3 of thromboprophylaxis', 'description': 'Trough anti-Xa levels, drawn right before the third enoxaparin dose is given'}, {'measure': 'Bleeding according to the GUSTO bleeding criteria.', 'timeFrame': 'Bleeding within 30 days will be assessed from randomization till date of bleeding or date of discharge, whichever comes first.'}, {'measure': 'Objectively confirmed symptomatic or asymptomatic venous thromboembolism (VTE) including both deep vein thrombosis (DVT) and or pulmonary embolism (PE).', 'timeFrame': 'Venous thromboembolism (VTE) within 30 days will be assessed from randomization till date of VTE or date of discharge, whichever comes first.', 'description': 'Chart documentation of objectively detected DVT by either bilateral venography or duplex ultrasonography whereas PE detection by contrast enhanced computerized tomography scan (CT Scan) or Magnetic resonance imaging (MRI).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Anticoagulation', 'Thromboprophylaxis', 'Anti-Xa levels', 'Elderly', 'Prevention', 'Enoxaparin', 'Low molecular weight heparin'], 'conditions': ['Venous Thromboembolism', 'Renal Impairment']}, 'referencesModule': {'references': [{'pmid': '31064405', 'type': 'DERIVED', 'citation': 'Chamoun N, Ghanem H, Hachem A, Hariri E, Lteif C, Mansour H, Dimassi H, Zalloum R, Ghanem G. Evaluation of prophylactic dosages of Enoxaparin in non-surgical elderly patients with renal impairment. BMC Pharmacol Toxicol. 2019 May 7;20(1):27. doi: 10.1186/s40360-019-0308-8.'}]}, 'descriptionModule': {'briefSummary': 'This is a clinical trial including non-surgical patients, 70 years of age or older, with renal impairment requiring pharmacological venous thromboembolism prevention during hospitalization. Patients are randomized to receive either 20 mg or 30mg of enoxaparin. Both dosing regimens of enoxaparin have been approved for thromboprophylaxis in impaired kidney function in different countries. Therefore, this study aims to evaluate the efficacy and safety of enoxaparin 20mg versus 30mg subcutaneously daily by comparing anti-xa levels, thrombosis and bleeding events.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '70 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Non-surgical patients\n* 70 years of age or older\n* With renal impairment (creatinine clearance ≤35ml/min)\n* Requiring pharmacological thromboprophylaxis\n\nExclusion Criteria:\n\n* Indication for a treatment dose of anticoagulant treatment\n* Knee surgery or hip surgery within 10 to 35 days, respectively\n* Surgery, trauma, hemodialysis, peritoneal dialysis, or bleeding\n* History of heparin-induced thrombocytopenia\n* Known or suspected hypersensitivity to any component of study drug\n* Patients with an excessive risk of bleeding and not eligible for pharmacological thromboprophylaxis based on physician assessment or due to any of the 3 major risk factors including active gastroduodenal ulcer, bleeding within the past three months prior to hospital admission, or a platelet count of \\<50,000 platelets/ mm3'}, 'identificationModule': {'nctId': 'NCT03158792', 'briefTitle': 'Enoxaparin 20mg Versus 30mg Subcutaneously Once Daily in Elderly Patients With Impaired Renal Function', 'organization': {'class': 'OTHER', 'fullName': 'Lebanese American University'}, 'officialTitle': 'Evaluation of Non-Surgical Venous Thromboembolism Prophylaxis Dosing Strategies: Enoxaparin 20mg Versus 30mg Subcutaneously Once Daily in Elderly Patients With Impaired Renal Function', 'orgStudyIdInfo': {'id': 'LAU.SOP.NC1.25/Jun/2015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Enoxaparin 20 mg', 'interventionNames': ['Drug: Enoxaparin 20Mg/0.2mL Prefilled Syringe']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Enoxaparin 30 mg', 'interventionNames': ['Drug: Enoxaparin 60Mg/0.6Ml Inj Syringe 0.6Ml']}], 'interventions': [{'name': 'Enoxaparin 20Mg/0.2mL Prefilled Syringe', 'type': 'DRUG', 'description': 'Enoxaparin 20mg subcutaneously once daily', 'armGroupLabels': ['Enoxaparin 20 mg']}, {'name': 'Enoxaparin 60Mg/0.6Ml Inj Syringe 0.6Ml', 'type': 'DRUG', 'description': 'Enoxaparin 30mg subcutaneously once daily. Half of the graduated 60Mg/0.6Ml Inj Syringe is administered', 'armGroupLabels': ['Enoxaparin 30 mg']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beirut', 'country': 'Lebanon', 'facility': 'LAU Medical Center-Rizk Hospital', 'geoPoint': {'lat': 33.89332, 'lon': 35.50157}}], 'overallOfficials': [{'name': 'Nibal R Chamoun, PharmD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lebanese American University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lebanese American University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Assistant Professor of Pharmacy Practice and Clinical Coordinator', 'investigatorFullName': 'Nibal Chamoun', 'investigatorAffiliation': 'Lebanese American University'}}}}