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National, Prospective, Observational, Cohort Study of Venous Thromboembolism (VTE) Management With the Low Molecular Weight Heparin, Enoxaparin, in the Outpatient Setting in Canada


N/A
18 Years
N/A
Not Enrolling
Both
Medical Prevention Therapy

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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

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