Enoxaparin in Acute Venous Thromboembolic Disease

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 objectives :

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

Study Overview

• Status: Completed
• Conditions: Venous Thrombosis
• Intervention / Treatment: Drug: enoxaparin

• Study Type: Interventional
• Enrollment (Actual): 251
• Phase: Phase 4

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Sanofi-Aventis Administrative Office

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; enoxaparin	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	3 months

Collaborators and Investigators

• Sponsor: Sanofi

Study record dates

Study Major Dates

• Study Start: December 1, 2004
• Primary Completion (Actual): January 1, 2009
• Study Completion (Actual): January 1, 2009

Study Registration Dates

• First Submitted: December 14, 2005
• First Submitted That Met QC Criteria: December 14, 2005
• First Posted (Estimate): December 15, 2005

Study Record Updates

• Last Update Posted (Estimate): February 3, 2010
• Last Update Submitted That Met QC Criteria: February 2, 2010
• Last Verified: February 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thrombosis; Venous Thrombosis; Thromboembolism; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Anticoagulants; Enoxaparin
• Other Study ID Numbers: XRP4563A_4001