Enoxaparin in Acute Venous Thromboembolic Disease

Sanofi

Status and phase

Completed

Phase 4

Conditions

Venous Thrombosis

Treatments

Drug: enoxaparin

Study type

Interventional

Funder types

Industry

Identifiers

XRP4563A_4001

Details and patient eligibility

About

Study objectives :

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

Enrollment

251 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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