Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
915 participants
OBSERVATIONAL
2007-08-31
2010-06-30
Brief Summary
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\- To obtain prospective, clinical practice-based data on how symptomatic VTE is managed with low molecular weight heparin (LMWH) enoxaparin in Canadian outpatient settings.
Secondary Objective:
* To describe the demographic and clinical characteristics of patients with symptomatic VTE including characteristics of VTE, VTE risk factors and bleeding risk factors.
* To assess the frequency of patient characteristics that would necessitate adjustment in the dose or duration of enoxaparin therapy, e.g. high BMI, impaired creatinine clearance, advanced age, cancer-associated VTE.
* To assess the degree of adherence in clinical practice to Consensus Guidelines (ACCP/American College of chest Physician 2008) for the management of acute VTE, vis a vis:
* Appropriate dosing of enoxaparin
* Recommended duration of initial LMWH therapy
* Adequate overlap of LMWH with vitamin K antagonists (VKA)
* Recommended duration of longterm VKA
* Frequency of use of LMWH monotherapy to treat cancer-related VTE
* To access safety outcomes (including bleeding and recurrent VTE)
* To describe the utilization of resources due to bleeding and recurrent VTE during the treatment period.
Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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VTE management registry
Patients receiving enoxaparin, with or without oral anticoagulation, within Day 0-10 after diagnosis of VTE
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Initiation of enoxaparin treatment within Day 0-10 after diagnosis of VTE:
* Outpatients who will be treated with enoxaparin + VKA in combination are permitted to receive initial treatment other than enoxaparin for a maximum of 48 hours or 2 treatment doses preceding entry into the study
* Outpatients on enoxaparin monotherapy are permitted to receive up to 10 days of treatment other than enoxaparin preceding entry into the study.
Exclusion Criteria
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18 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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sanofi-aventis
Principal Investigators
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Medical Affairs
Role: STUDY_DIRECTOR
Sanofi
Locations
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Sanofi-Aventis Administrative Office
Laval, , Canada
Countries
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Other Identifiers
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ENOXA_L_02260
Identifier Type: -
Identifier Source: org_study_id