Canadian Outpatient VTE Management Registry (RECOVERY)

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT01133002
First received: May 26, 2010
Last updated: August 30, 2010
Last verified: August 2010
  Purpose

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.

Condition
Medical Prevention Therapy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: National, Prospective, Observational, Cohort Study of Venous Thromboembolism (VTE) Management With the Low Molecular Weight Heparin, Enoxaparin, in the Outpatient Setting in Canada

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Proportion of patients with Deep Venous Thrombosis (DVT) and/or Pulmonary Embolism (PE) and/or thrombosis at unusual sites [ Time Frame: Day 180 or end of anticoagulant therapy whichever comes first ] [ Designated as safety issue: No ]
  • Number of patients prescribed twice daily (BID) vs. once daily (QD) enoxaparin [ Time Frame: Day 180 or end of anticoagulant therapy whichever comes first ] [ Designated as safety issue: No ]
  • Proportion of patients who used short (5-7 days) vs. longer use (more than 7 days) durations of treatment with enoxaparin [ Time Frame: Day 180 or end of anticoagulant therapy whichever comes first ] [ Designated as safety issue: No ]
  • Percentage of exnoxaparin prefilled syringes vs. multidose vials used during treatment [ Time Frame: Day 180 or end of anticoagulant therapy whichever comes first ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient characteristics associated with different patterns of VTE management and enoxaparin use [ Time Frame: Day 180 or end of anticoagulant therapy whichever comes first ] [ Designated as safety issue: No ]
    Analysis of patient characteristics associated with different patterns of VTE management and enoxaparin use, such as age, weight, creatinine clearance, co-morbid disease, VTE characteristics, concomitant use of other pharmacological and non-pharmacological treatment of the VTE, concomitant use of other non-VTE related therapies

  • Percentage of cases managed as recommended by Concensus Guidelines (ACCP 2008) [ Time Frame: Day 180 or end of anticoagulant therapy whichever comes first ] [ Designated as safety issue: No ]
  • Incidence of bleeding events and episodes of recurrent VTE [ Time Frame: Day 180 or end of anticoagulant therapy whichever comes first ] [ Designated as safety issue: Yes ]
  • To tabulate VTE-related resources utilized during the study period and compare resource utilization in patients treated vs not treated as per Concensus Guidelines (ACCP 2008) [ Time Frame: Day 180 or end of anticoagulant therapy whichever comes first ] [ Designated as safety issue: No ]
    VTE-related resources utilized during the study period, including cost of VTE and its treatment (e.g. duration of hospital stay, drug costs, costs related to bleeding such as transfusions, costs of recurrent VTE) and compare resource utilization in patients treated vs. not treated as recommended by Concensus Guidelines (ACCP 2008)


Enrollment: 915
Study Start Date: August 2007
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
VTE management registry
Patients receiving enoxaparin, with or without oral anticoagulation, within Day 0-10 after diagnosis of VTE

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with objectively confirmed symptomatic VTE treated at approximately 15 outpatient clinics across Canada which use enoxaparin for the treatment of acute VTE.

Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01133002

Locations
Canada
Sanofi-Aventis Administrative Office
Laval, Canada
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Medical Affairs Sanofi
  More Information

No publications provided

Responsible Party: Medical Affairs study director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT01133002     History of Changes
Other Study ID Numbers: ENOXA_L_02260
Study First Received: May 26, 2010
Last Updated: August 30, 2010
Health Authority: Canada: Ethics Review Committee

ClinicalTrials.gov processed this record on September 30, 2014