Ignite Creation Date:
2025-12-25 @ 3:10 AM
Ignite Modification Date:
2026-01-01 @ 2:21 AM
Study NCT ID:
NCT00077805
Status:
COMPLETED
Last Update Posted:
2011-01-11
First Post:
2004-02-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PREVAIL: PREvention of VTE After Acute Ischemic Stroke With LMWH Enoxaparin ( - VTE: Venous Thromboembolism - LMWH: Low Molecular Weight Heparin)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Greece']}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}], 'ancestors': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000711671', 'term': 'enoxaparin sodium'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-01', 'lastUpdateSubmitDate': '2011-01-10', 'studyFirstSubmitDate': '2004-02-12', 'studyFirstSubmitQcDate': '2004-02-13', 'lastUpdatePostDateStruct': {'date': '2011-01-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-02-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cumulative occurrence of VTE events (deep-vein thrombosis, pulmonary embolism)', 'timeFrame': '10 ± 4 days following acute ischemic stroke'}], 'secondaryOutcomes': [{'measure': 'cumulative VTE events', 'timeFrame': 'at 30-day, 60-day and 90-day'}, {'measure': 'stroke recurrence, stroke progression, National Institute of Health Stroke Scale (NIHSS) scores', 'timeFrame': 'during treatment and follow-up periods'}, {'measure': 'Modified Rankin Scale (MRS) scores', 'timeFrame': 'at 30-day and 90-day follow-up'}, {'measure': 'major & minor hemorrhages', 'timeFrame': 'from the inform consent signed up to the end of the study'}, {'measure': 'Treatment emergent adverse events (TEAE), serious adverse events (SAE), all-cause mortality', 'timeFrame': 'from the inform consent signed up to the end of the study'}]}, 'conditionsModule': {'conditions': ['Acute Ischemic Stroke']}, 'referencesModule': {'references': [{'pmid': '19696423', 'type': 'RESULT', 'citation': "Kase CS, Albers GW, Bladin C, Fieschi C, Gabbai AA, O'Riordan W, Pineo GF; PREVAIL Investigators. Neurological outcomes in patients with ischemic stroke receiving enoxaparin or heparin for venous thromboembolism prophylaxis: subanalysis of the Prevention of VTE after Acute Ischemic Stroke with LMWH (PREVAIL) study. Stroke. 2009 Nov;40(11):3532-40. doi: 10.1161/STROKEAHA.109.555003. Epub 2009 Aug 20."}, {'pmid': '17448820', 'type': 'RESULT', 'citation': "Sherman DG, Albers GW, Bladin C, Fieschi C, Gabbai AA, Kase CS, O'Riordan W, Pineo GF; PREVAIL Investigators. The efficacy and safety of enoxaparin versus unfractionated heparin for the prevention of venous thromboembolism after acute ischaemic stroke (PREVAIL Study): an open-label randomised comparison. Lancet. 2007 Apr 21;369(9570):1347-1355. doi: 10.1016/S0140-6736(07)60633-3."}]}, 'descriptionModule': {'briefSummary': 'Primary objective:\n\n* To demonstrate superiority of enoxaparin 40 mg sc qd in the prevention of VTE compared to UFH (unfractionated heparin) 5000 U sc q12 hours given for 10 ± 4 days following acute ischemic stroke.\n\nSecondary objectives:\n\n* To compare the incidence of VTE between the 2 treatment groups at 30, 60, and 90 days from the time of randomization\n* To compare neurologic outcomes between the 2 treatment groups, including incidence of stroke recurrence, rate of stroke progression, and patient functional status, during the 10 ± 4 days of treatment, and after 30, 60, and 90 days from the time of randomization\n* To evaluate the safety of using enoxaparin compared to UFH for VTE prevention in patients following acute ischemic stroke'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Acute ischemic stroke, any territory, with an appropriate neuroradiologic study (head CT scan or brain MRI scan) providing results consistent with non hemorrhagic stroke\n* Onset of symptoms of qualifying stroke within 48 hours prior to randomization. In patients receiving thrombolytic therapy for the acute stroke, such as tissue-type plasminogen activator (tPA), administration of study drug may not start until at least 24 hours after completion of thrombolytic therapy\n* Significant motor impairment of the leg, as indicated by a NIHSS score ≥2 on item 6\n* Inability to walk without assistance\n\nExclusion criteria:\n\n* Females who are pregnant, breast-feeding, or of childbearing potential and not using medically acceptable and effective contraception\n* Clinical evidence of VTE at screening\n* Any evidence of active bleeding on the basis of clinical judgment\n* Prior history of intracranial hemorrhage (including that at screening)\n* Spinal or epidural analgesia or lumbar puncture within the preceding 24 hours\n* Thrombolytic therapy (e.g., tPA) or intra-arterial thrombolytic therapy within the preceding 24 hours.Thrombolytic therapy is permitted for treatment of the acute stroke but must have been completed 24 hours prior to randomization.\n* Comatose at screening (NIHSS score ≥2 on item 1a)\n* Known or suspected cerebral aneurysm or arteriovenous malformation\n* Confirmed malignancy that may pose an increased risk for bleeding or otherwise compromise follow-up or outcome assessment (e.g., lung cancer)\n* Impaired hemostasis, i.e., known or suspected coagulopathy (acquired or inherited); baseline platelet count \\<100,000/mm3; aPTT 1.5 X the laboratory upper limit of normal; or international normalized ratio(INR) \\>1.5\n* Major surgery or recent major trauma within the previous 3 months\n* Anticipated need for full-dose treatment with therapeutic levels of an anticoagulant (LMWH, UFH, oral anticoagulant), e.g., for cardiogenic source of embolism or dissection\n* Treatment with a LMWH or UFH at prophylactic dose for more than 48 hours prior to randomization(patients receiving LMWH or UFH less than 48 hours prior to randomization may be randomized)\n* Allergy to heparin or enoxaparin sodium, or known hypersensitivity to heparin, enoxaparin, or pork products\n* History of heparin or enoxaparin induced thrombocytopenia and/or thrombosis (heparin-induced thrombocytopenia \\[HIT\\], heparin-associated thrombocytopenia \\[HAT\\], or heparin-induced thrombotic thrombocytopenia syndrome \\[HITTS\\])\n* History of hypersensitivity to iodinated contrast media and/or iodine\n* Bacterial endocarditis\n* Prosthetic heart valve\n* Known or suspected severe anemia (Hg \\<10.0 g/dL)\n* Uncontrolled arterial hypertension (systolic blood pressure \\[BP\\] \\>180 mmHg or diastolic BP \\>100 mmHg) at the time of randomization or clinical hypertensive urgency\n* Any other clinically relevant serious diseases, including severe liver disease or renal failure \\[creatinine clearance \\<30 mL/min on at least two occasions\\].\n* Treatment with other investigational agents or devices within the previous 30 days, planned use of other investigational drugs or devices, or previous enrollment in this study.'}, 'identificationModule': {'nctId': 'NCT00077805', 'briefTitle': 'PREVAIL: PREvention of VTE After Acute Ischemic Stroke With LMWH Enoxaparin ( - VTE: Venous Thromboembolism - LMWH: Low Molecular Weight Heparin)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'An Open-Label, Randomized, Parallel-Group, Multi-Center Study to Evaluate the Efficacy and Safety of Enoxaparin Versus Unfractionated Heparin in the Prevention of Venous Thromboembolism in Patients Following Acute Ischemic Stroke', 'orgStudyIdInfo': {'id': 'XRP4563H_4001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Enoxaparin sodium', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bridgewater', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Sanofi-Aventis', 'geoPoint': {'lat': 40.60079, 'lon': -74.64815}}, {'city': 'North Ryde', 'country': 'Australia', 'facility': 'Sanofi-Aventis', 'geoPoint': {'lat': -33.79677, 'lon': 151.12436}}, {'city': 'Vienna', 'country': 'Austria', 'facility': 'Sanofi-Aventis', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Sanofi-Aventis', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'city': 'Laval', 'country': 'Canada', 'facility': 'Sanofi-Aventis', 'geoPoint': {'lat': 45.56995, 'lon': -73.692}}, {'city': 'Bogotá', 'country': 'Colombia', 'facility': 'Sanofi-Aventis', 'geoPoint': {'lat': 4.60971, 'lon': -74.08175}}, {'city': 'Prague', 'country': 'Czechia', 'facility': 'Sanofi-Aventis', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'Mumbai', 'country': 'India', 'facility': 'Sanofi-Aventis', 'geoPoint': {'lat': 19.07283, 'lon': 72.88261}}, {'city': 'Netanya', 'country': 'Israel', 'facility': 'Sanofi-Aventis', 'geoPoint': {'lat': 32.33291, 'lon': 34.85992}}, {'city': 'Milan', 'country': 'Italy', 'facility': 'Sanofi-Aventis', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'city': 'México', 'country': 'Mexico', 'facility': 'Sanofi-Aventis', 'geoPoint': {'lat': 31.00435, 'lon': -108.15213}}, {'city': 'Warsaw', 'country': 'Poland', 'facility': 'Sanofi-Aventis', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'city': 'Johannesburg', 'country': 'South Africa', 'facility': 'Sanofi-Aventis', 'geoPoint': {'lat': -26.20227, 'lon': 28.04363}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Sanofi-Aventis', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Sanofi-Aventis', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Luc Sagnard', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Medical Affairs Study Director', 'oldOrganization': 'sanofi-aventis'}}}}