Enoxaparin in Acute Venous Thromboembolic Disease

NCT ID: NCT00265993

Last Updated: 2010-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 251 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-12-31
• Study Completion Date: 2009-01-31

Brief Summary

Study objectives :

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

Conditions

Venous Thrombosis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

enoxaparin

Group Type: EXPERIMENTAL

enoxaparin

Intervention Type: DRUG

• 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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

sanofi-aventis

Principal Investigators

Edibe Taylan

Role: STUDY_DIRECTOR

Sanofi

Locations

Sanofi-Aventis Administrative Office

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

XRP4563A_4001

Identifier Type: -

Identifier Source: org_study_id