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.

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.