Enoxaparin in Acute Venous Thromboembolic Disease

Venous Thrombosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00265993
• Other study ID #: XRP4563A_4001
• Status: Completed
• Phase: Phase 4
• First received: December 14, 2005
• Last updated: February 2, 2010
• Start date: December 2004
• Est. completion date: January 2009

Study information

• Verified date: February 2010
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Study objectives :

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 251
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Thromboembolism
• Venous Thrombosis

Intervention

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.

Locations

Country	Name	City	State
Turkey	Sanofi-Aventis Administrative Office	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No