Canadian Outpatient VTE Management Registry (RECOVERY)

Sanofi

Status: Completed

Conditions: Medical Prevention Therapy

Study type: Observational

Funder types: Industry

Identifiers

NCT01133002

ENOXA_L_02260

Details and patient eligibility

About

Primary Objective:

• 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.

Enrollment: 915 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Objectively confirmed VTE
• 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

• Medical or psychiatric disorders associated with altered cognition or mentation that precludes understanding of the informed consent process.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Trial design

915 participants in 1 patient group

VTE management registry

Description:

Patients receiving enoxaparin, with or without oral anticoagulation, within Day 0-10 after diagnosis of VTE