Trial Information
National, Prospective, Observational, Cohort Study of Venous Thromboembolism (VTE) Management With the Low Molecular Weight Heparin, Enoxaparin, in the Outpatient Setting in Canada
Inclusion 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.
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
Proportion of patients with Deep Venous Thrombosis (DVT) and/or Pulmonary Embolism (PE) and/or thrombosis at unusual sites
Outcome Time Frame:
Day 180 or end of anticoagulant therapy whichever comes first
Safety Issue:
No
Principal Investigator
Medical Affairs
Investigator Role:
Study Director
Investigator Affiliation:
Sanofi
Authority:
Canada: Ethics Review Committee
Study ID:
ENOXA_L_02260
NCT ID:
NCT01133002
Start Date:
August 2007
Completion Date:
June 2010
Related Keywords:
- Medical Prevention Therapy
- Venous Thromboembolism