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Enoxaparin in Acute Venous Thromboembolic Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00265993
Recruitment Status : Completed
First Posted : December 15, 2005
Last Update Posted : February 3, 2010
Information provided by:

Brief Summary:

Study objectives :

  • To evaluate the efficacy/safety profile of enoxaparin once a day treatment in acute venous thromboembolic disease.

Condition or disease Intervention/treatment Phase
Venous Thrombosis Drug: enoxaparin Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 251 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Efficacy of Subcutaneous Enoxaparin Once Daily in the Treatment of Acute Venous Thromboembolic Disease: an Open-labelled, Non-comparative, Multicentric, Phase IV Trial
Study Start Date : December 2004
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2009

Arm Intervention/treatment
Experimental: 1
Drug: enoxaparin
  • All patients will be treated with enoxaparin 1.5 mg/kg, once a day, subcutaneously for up to 10 days.
  • Long-term oral anticoagulation will be started in all patients after 24 hours of initiation of enoxaparin treatment and continued at least for 3 months.

Primary Outcome Measures :
  1. Frequency of bleeding emerged during the study drug administration; Frequency of bleeding emerged during 3 months of monitorization when the patient is on oral anticoagulants. [ Time Frame: 3 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with symptomatic lower-extremity deep venous thrombosis confirmed by doppler USG (ultrasonography), with or without confirmed symptomatic pulmonary embolism associated with provoked risk factors

Exclusion Criteria:

  • Patients with a history of heparin or warfarin treatment longer than 24 hours,
  • Patients requiring thrombolytic treatment,
  • Patients having thrombophilia diagnosis,
  • Patients with prior deep vein thrombosis or pulmonary emboli evidence,
  • Patients with familial bleeding disorder,
  • Patients who are at any known bleeding risk, such as active bleeding, active ulcerative bowel disease, angiodysplasia and having oculary, spinal or central nervous system surgery within the last month
  • Patients with renal failure (serum creatinine concentration > 180 mmol/L or > 2.03 mg/dL),
  • Patients with severe hepatic failure
  • Patients with history of allergy against heparin and protamine,
  • Patients with history of thrombocytopenia associated with heparin administration or of skin necrosis after heparin or warfarin treatment,
  • Patients participating in another clinical study within the last 4 months
  • Patients who are pregnant

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00265993

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Sanofi-Aventis Administrative Office
Istanbul, Turkey
Sponsors and Collaborators
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Study Director: Edibe Taylan Sanofi

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Responsible Party: Medical Affairs Study Director, sanofi-aventis Identifier: NCT00265993    
Other Study ID Numbers: XRP4563A_4001
First Posted: December 15, 2005    Key Record Dates
Last Update Posted: February 3, 2010
Last Verified: February 2010
Additional relevant MeSH terms:
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Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases