Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2025-12-27 @ 11:27 PM
Study NCT ID:
NCT00721760
Status:
COMPLETED
Last Update Posted:
2013-01-23
First Post:
2008-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of AVE5026 as Compared to Enoxaparin for the Prevention of Thromboembolism in Patients Undergoing Hip Fracture Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054556', 'term': 'Venous Thromboembolism'}, {'id': 'D006620', 'term': 'Hip Fractures'}], 'ancestors': [{'id': 'D013923', 'term': 'Thromboembolism'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D005264', 'term': 'Femoral Fractures'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D025981', 'term': 'Hip Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000711671', 'term': 'enoxaparin sodium'}, {'id': 'D017984', 'term': 'Enoxaparin'}, {'id': 'C542814', 'term': 'AVE 5026'}], '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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1003}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'dispFirstSubmitDate': '2010-12-20', 'completionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-14', 'studyFirstSubmitDate': '2008-07-22', 'dispFirstSubmitQcDate': '2010-12-20', 'studyFirstSubmitQcDate': '2008-07-22', 'dispFirstPostDateStruct': {'date': '2010-12-28', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2013-01-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-07-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Overview of deaths', 'timeFrame': 'From first study drug injection up to 3 days after last study drug injection', 'description': 'All deaths were centrally and blindly reviewed by the CIAC and classified as fatal PE, fatal bleeding, cardiovascular death or other based on relevant documentation (e.g. autopsy report).'}, {'measure': 'Platelets Count: Percentage of Participants With Potentially Clinically Significant Abnormalities [PCSA]', 'timeFrame': 'From first study drug injection up to 3 days after last study drug injection', 'description': 'PCSA are abnormal values considered medically important by the Sponsor according to predefined criteria based on literature review.\n\nThreshold for platelet counts was defined as \\<100 Giga/L.'}, {'measure': 'Liver Function: Percentage of Participants With Potentially Clinically Significant Abnormalities [PCSA]', 'timeFrame': 'From first study drug injection up to 3 days after last study drug injection', 'description': "Thresholds were defined as follows:\n\n* Alanine Aminotransferase \\[ALAT\\] \\>3 Upper Normal Limit \\[ULN\\];\n* Total Bilirubin \\[TB\\] \\>2 ULN;\n* ALAT \\>3 ULN and TB \\>2 ULN;\n\nCases with ALAT \\>3 ULN and TB \\>2 ULN (not necessarily concomitant) were evaluated by a blinded independent adjudicator to determine if they met Hy's law criteria."}], 'primaryOutcomes': [{'measure': 'Percentage of Participants Who Experienced Venous Thromboembolism Event [VTE] or All-cause Death', 'timeFrame': 'From randomization up to 10 days after surgery or the day of mandatory venography, whichever came first', 'description': 'VTE included any Deep Vein Thrombosis \\[DVT\\] (proximal or distal, symptomatic or not) and non-fatal Pulmonary Embolism \\[PE\\] as confirmed by a Central Independent Adjudication Committee \\[CIAC\\] after review of mandatory bilateral venograms and diagnostic tests for VTE.\n\nAll-cause deaths included fatal PE and deaths for other reason than PE.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Who Experienced "Major" VTE or All-cause Death', 'timeFrame': 'From randomization up to 10 days after surgery or the day of mandatory venography, whichever came first', 'description': '"major" VTE included any proximal DVT, symptomatic distal DVT and non-fatal PE as confirmed by the CIAC.'}, {'measure': 'Percentage of Participants Who Experienced Clinically Relevant Bleedings', 'timeFrame': 'From first study drug injection up to 3 days after last study drug injection', 'description': 'Bleedings were centrally and blindly reviewed by the CIAC and classified as:\n\n* "major" (fatal, in a critical area/organ, causing a post-operative drop in hemoglobin ≥2 g/dL or requiring post-operative transfusion ≥2 units of blood, leading to an invasive diagnostic or therapeutic intervention, or associated with circulatory decompensation);\n* "clinically relevant non-major" (skin hematoma or epistaxis requiring surgical/medical intervention/treatment, macroscopic hematuria, or overt bleeding requiring specific attention by healthcare professional);\n* "Non-clinically relevant bleeding".'}, {'measure': 'Percentage of Participants Who Required the Initiation of Curative Anticoagulant or Thrombolytic Treatment After VTE Assessment', 'timeFrame': 'From randomization up to 10 days after surgery or the day of mandatory venography, whichever came first', 'description': 'Initiation of curative anticoagulant or thrombolytic treatment after VTE assessment was defined from investigator\'s answer to the question "was the subject treated for VTE?" asked after the diagnostic tests for suspected VTE and after the mandatory venography.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Hip fractures', 'Heparin Low-Molecular-Weight', 'Randomized Controlled Trial'], 'conditions': ['Venous Thromboembolism']}, 'referencesModule': {'references': [{'pmid': '22429800', 'type': 'RESULT', 'citation': 'Lassen MR, Fisher W, Mouret P, Agnelli G, George D, Kakkar A, Mismetti P, Turpie AG; SAVE Investigators. Semuloparin for prevention of venous thromboembolism after major orthopedic surgery: results from three randomized clinical trials, SAVE-HIP1, SAVE-HIP2 and SAVE-KNEE. J Thromb Haemost. 2012 May;10(5):822-32. doi: 10.1111/j.1538-7836.2012.04701.x.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective was to compare the efficacy of once daily \\[q.d\\] subcutaneous \\[s.c.\\] injections of Semuloparin sodium (AVE5026) with q.d. s.c. injections of Enoxaparin for the prevention of Venous Thromboembolic Events \\[VTE\\] in patients undergoing hip fracture surgery.\n\nThe secondary objectives were to evaluate the safety of AVE5026 in patients undergoing hip fracture surgery, and to document AVE5026 exposure in this population.', 'detailedDescription': 'Randomization had to take place just prior to the first study drug injection (randomization ratio 1:1).\n\nThe total duration of observation per participant was 35-42 days from surgery broken down as follows:\n\n* 7 to 10-day double-blind treatment period;\n* 28 to 35-day follow-up period.\n\nMandatory bilateral venography of the lower limbs had to be performed between 7 to 11 days after surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Standard surgery for fracture of the upper third of the femur including femoral head and neck.\n\nExclusion Criteria:\n\n* Estimated time of injury/fracture \\> 24 hours before admission to hospital;\n* Any major orthopedic surgery in the 3 months prior to study start;\n* Multiple trauma affecting more than one organ system;\n* Deep vein thrombosis or pulmonary embolism within the last 12 months or known post-phlebitic syndrome;\n* High risk of bleeding;\n* Known allergy to heparin, or enoxaparin, or pork products;\n* End stage renal disease or patient on dialysis;\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT00721760', 'acronym': 'SAVE-HIP2', 'briefTitle': 'Evaluation of AVE5026 as Compared to Enoxaparin for the Prevention of Thromboembolism in Patients Undergoing Hip Fracture Surgery', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'A Multinational, Multicenter, Randomized, Double-Blind Study Comparing the Efficacy and Safety of AVE5026 With Enoxaparin for the Prevention of Venous Thromboembolism in Patients Undergoing Hip Fracture Surgery', 'orgStudyIdInfo': {'id': 'EFC10343'}, 'secondaryIdInfos': [{'id': '2007-007945-11', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Semuloparin', 'description': 'Semuloparin sodium 20 mg (10 mg if Severe Renal Impairment \\[SRI\\]) once daily for 7-10 days with an initial dose given 8 hours after surgery\n\nPlacebo for Enoxaparin sodium prior to surgery according to local standard for Enoxaparin and 12 hours after surgery to maintain the blind', 'interventionNames': ['Drug: Semuloparin sodium', 'Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Enoxaparin', 'description': 'Enoxaparin sodium 40 mg (20 mg if Severe Renal Impairment \\[SRI\\]) once daily for 7-10 days with an initial dose given prior to or 12 hours after surgery according to local standard for Enoxaparin sodium\n\nPlacebo for Semuloparin sodium 8 hours after surgery to maintain the blind', 'interventionNames': ['Drug: Enoxaparin sodium', 'Drug: Placebo']}], 'interventions': [{'name': 'Enoxaparin sodium', 'type': 'DRUG', 'otherNames': ['Lovenox®'], 'description': '0.4 mL (0.2 mL if SRI) solution in ready-to-use 0.5 ml pre-filled syringe\n\nSubcutaneous injection', 'armGroupLabels': ['Enoxaparin']}, {'name': 'Semuloparin sodium', 'type': 'DRUG', 'otherNames': ['AVE5026'], 'description': '0.4 mL (0.2 mL if SRI) solution in ready-to-use 0.5 ml pre-filled syringe\n\nSubcutaneous injection', 'armGroupLabels': ['Semuloparin']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '0.4 mL (0.2 mL if SRI) solution in ready-to-use 0.5 ml prefilled syringe strictly identical in appearance but without active component\n\nSubcutaneous injection', 'armGroupLabels': ['Enoxaparin', 'Semuloparin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08807', 'city': 'Bridgewater', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 40.60079, 'lon': -74.64815}}, {'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'city': 'Minsk', 'country': 'Belarus', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 53.90019, 'lon': 27.56653}}, {'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'city': 'Laval', 'country': 'Canada', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 45.56995, 'lon': -73.692}}, {'city': 'Santiago', 'country': 'Chile', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'city': 'Shangaï', 'country': 'China', 'facility': 'Sanofi-Aventis Administrative Office'}, {'city': 'Bogotá', 'country': 'Colombia', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 4.60971, 'lon': -74.08175}}, {'city': 'Prague', 'country': 'Czechia', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'Hørsholm', 'country': 'Denmark', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 55.88098, 'lon': 12.50111}}, {'city': 'Helsinki', 'country': 'Finland', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}, {'city': 'Athens', 'country': 'Greece', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'city': 'Mumbai', 'country': 'India', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 19.07283, 'lon': 72.88261}}, {'city': 'Milan', 'country': 'Italy', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'city': 'México', 'country': 'Mexico', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 31.00435, 'lon': -108.15213}}, {'city': 'Lima', 'country': 'Peru', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': -12.04318, 'lon': -77.02824}}, {'city': 'Warsaw', 'country': 'Poland', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'city': 'Porto Salvo', 'country': 'Portugal', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 38.72293, 'lon': -9.30473}}, {'city': 'Bucharest', 'country': 'Romania', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'city': 'Moscow', 'country': 'Russia', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Midrand', 'country': 'South Africa', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': -25.976, 'lon': 28.118}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Bromma', 'country': 'Sweden', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 59.34, 'lon': 17.94}}, {'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'city': 'Kiev', 'country': 'Ukraine', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 50.45466, 'lon': 30.5238}}], 'overallOfficials': [{'name': 'William D. Fisher, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Orthopaedic Surgery, McGill University Health Centre, 1650 Cedar Avenue, Montreal, Quebec, H3G 1A4, Canada'}, {'name': 'Alexander G. Turpie', 'role': 'STUDY_CHAIR', 'affiliation': 'McMaster University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}