Ignite Creation Date:
2025-12-25 @ 4:49 AM
Ignite Modification Date:
2026-03-04 @ 8:38 PM
Study NCT ID:
NCT00345618
Status:
COMPLETED
Last Update Posted:
2016-03-21
First Post:
2006-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Study Assessing Idrabiotaparinux Sodium Injections Once-weekly in Pulmonary Embolism Therapeutic Approach
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Finland', 'Germany', 'Hungary', 'Lebanon', 'New Zealand']}, 'conditionBrowseModule': {'meshes': [{'id': 'D004617', 'term': 'Embolism'}, {'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D020246', 'term': 'Venous Thrombosis'}, {'id': 'D011655', 'term': 'Pulmonary Embolism'}], 'ancestors': [{'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014859', 'term': 'Warfarin'}, {'id': 'D001360', 'term': 'Avidin'}, {'id': 'D017984', 'term': 'Enoxaparin'}], 'ancestors': [{'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'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D010047', 'term': 'Ovalbumin'}, {'id': 'D000418', 'term': 'Albumins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D015387', 'term': 'Egg Proteins, Dietary'}, {'id': 'D000080224', 'term': 'Animal Proteins, Dietary'}, {'id': 'D004044', 'term': 'Dietary Proteins'}, {'id': 'D004527', 'term': 'Egg Proteins'}, {'id': 'D006495', 'term': 'Heparin, Low-Molecular-Weight'}, {'id': 'D006493', 'term': 'Heparin'}, {'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3202}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'dispFirstSubmitDate': '2016-02-19', 'completionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-19', 'studyFirstSubmitDate': '2006-06-27', 'dispFirstSubmitQcDate': '2016-02-19', 'studyFirstSubmitQcDate': '2006-06-27', 'dispFirstPostDateStruct': {'date': '2016-03-21', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2016-03-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-06-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recurrence of symptomatic, fatal or not, VTE (PE or DVT) as confirmed by a Central Independent Adjudication Committee (CIAC)', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'Recurrence of symptomatic, fatal or not, VTE (PE or DVT) as confirmed by a Central Independent Adjudication Committee (CIAC)', 'timeFrame': '6 months'}, {'measure': 'Incidence of any clinically relevant bleeding as classified by the CIAC (ie, major bleeding and other clinically relevant non major bleeding)', 'timeFrame': '3 months, 6 months and 3- to 6-month post-treatment follow-up'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Deep venous thrombosis', 'pulmonary embolism', 'anticoagulant drugs'], 'conditions': ['Embolism', 'Thrombosis']}, 'referencesModule': {'references': [{'pmid': '22130488', 'type': 'RESULT', 'citation': 'Buller HR, Gallus AS, Pillion G, Prins MH, Raskob GE; Cassiopea Investigators. Enoxaparin followed by once-weekly idrabiotaparinux versus enoxaparin plus warfarin for patients with acute symptomatic pulmonary embolism: a randomised, double-blind, double-dummy, non-inferiority trial. Lancet. 2012 Jan 14;379(9811):123-9. doi: 10.1016/S0140-6736(11)61505-5. Epub 2011 Nov 28.'}]}, 'descriptionModule': {'briefSummary': 'Objectives are to evaluate whether idrabiotaparinux sodium (SSR126517E) is as least as effective as a standard warfarin treatment to prevent recurrence of venous thromboembolic events (VTE) in patients with symptomatic pulmonary embolism (PE) with or without symptomatic deep venous thrombosis (DVT) and to assess its safety (bleedings) versus warfarin.', 'detailedDescription': 'Treatment with a therapeutic dose of any low molecular weight heparin (LMWH) or unfractioned heparin (UFH) or fondaparinux is allowed only within the 36 hours immediately preceding randomization. Randomization is performed as soon as the diagnosis of PE (and DVT if concomitant suspected symptomatic DVT) is confirmed.\n\nAllocation to treatment is done centrally by Interactive Voice Response System (IVRS) and stratified by (1) center, (2) intended treatment duration, ie, 3 months or 6 months. At randomization, the planned duration of treatment (3 or 6 months) is prespecified by the Investigator and determined on the assessment of risk of VTE recurrence. Participants are randomized to either idrabiotaparinux + placebo of warfarin, or warfarin + placebo of idrabiotaparinux, with an initial treatment of at least 5 days with enoxaparin in both treatment groups.\n\nParticipants in the 3-month stratum have an additional 13-week observational period after cessation of study treatment. Participants in the 6-month stratum have a 13-week up to 26-week observational period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Symptomatic pulmonary embolism with or without symptomatic deep vein thrombosis\n\nExclusion Criteria:\n\n* End stage renal failure, hepatic failure, uncontrolled hypertension;\n* Active bleeding or high risk for bleeding;\n* Pregnancy or childbearing potential without proper contraceptive measures, threatened abortion.\n* Breastfeeding.\n* Known allergy to idraparinux or idrabiotaparinux, avidin or egg proteins;\n* hypersensitivity to warfarin, enoxaparin, heparin or pork product; or any other contraindication listed in the labelling of warfarin or enoxaparin;\n* Indication of prolonged anticoagulation therapy for other reason than PE;\n* Life expectancy \\< 6 months;'}, 'identificationModule': {'nctId': 'NCT00345618', 'acronym': 'CASSIOPEA', 'briefTitle': 'Clinical Study Assessing Idrabiotaparinux Sodium Injections Once-weekly in Pulmonary Embolism Therapeutic Approach', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'An International, Multicenter, Randomized, Double-blind, Double-dummy, Parallel Group, Study of 3-month or 6-month Treatment With SSR126517E (3.0 mg s.c. Once-weekly) Versus Oral INR-adjusted Warfarin in the Treatment of Patients With Symptomatic Pulmonary Embolism With or Without Symptomatic Deep Venous Thrombosis', 'orgStudyIdInfo': {'id': 'EFC6034'}, 'secondaryIdInfos': [{'id': 'EudraCT:2006-001786-42'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Idrabiotaparinux', 'description': 'Idrabiotaparinux sodium, 3.0 mg, once-weekly for 3 or 6 months depending on the stratum, after enoxaparin, 1.0 mg/kg, every 12 hours for at least 5 days.\n\nAvidin, 100 mg, at the discretion of the investigator whenever deemed appropriate and possible (ie, life-threatening bleeding, emergency invasive procedure with the potential of uncontrolled bleeding, or over-dosage).', 'interventionNames': ['Drug: Idrabiotaparinux sodium', 'Drug: Avidin', 'Drug: Placebo (for warfarin)', 'Drug: Enoxaparin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Warfarin', 'description': 'Warfarin, INR-adjusted dose, started 24 hours after the start of enoxaparin, 1.0 mg/kg, every 12 hours for at least 5 days, and continued for 3 or 6 months depending on the stratum.\n\nAvidin, 100 mg, at the discretion of the investigator whenever deemed appropriate and possible (ie, life-threatening bleeding, emergency invasive procedure with the potential of uncontrolled bleeding, or over-dosage).', 'interventionNames': ['Drug: Warfarin', 'Drug: Placebo (for idrabiotaparinux sodium)', 'Drug: Avidin', 'Drug: Enoxaparin']}], 'interventions': [{'name': 'Idrabiotaparinux sodium', 'type': 'DRUG', 'otherNames': ['Biotinylated Idraparinux', 'SSR126517'], 'description': '0.5 mL pre-filled syringe for 3.0 mg\n\nSubcutaneous injection', 'armGroupLabels': ['Idrabiotaparinux']}, {'name': 'Warfarin', 'type': 'DRUG', 'description': 'Capsules with 1 or 5 mg for INR-adjusted dose (INR checked at least once a month)\n\nOral administration', 'armGroupLabels': ['Warfarin']}, {'name': 'Placebo (for idrabiotaparinux sodium)', 'type': 'DRUG', 'description': '0.5 mL pre-filled syringe\n\nSubcutaneous injection', 'armGroupLabels': ['Warfarin']}, {'name': 'Avidin', 'type': 'DRUG', 'otherNames': ['SSR29261'], 'description': '100 mg in 10 mg/mL solution\n\nIntravenous infusion for 30 minutes', 'armGroupLabels': ['Idrabiotaparinux', 'Warfarin']}, {'name': 'Placebo (for warfarin)', 'type': 'DRUG', 'description': 'Warfarin matching capsules\n\nOral administration', 'armGroupLabels': ['Idrabiotaparinux']}, {'name': 'Enoxaparin', 'type': 'DRUG', 'description': 'Prefilled syringes as locally registered\n\nSubcutaneous injection', 'armGroupLabels': ['Idrabiotaparinux', 'Warfarin']}]}, '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, 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