Enoxaparin in Acute Venous Thromboembolic Disease

NCT00265993 | Completed Phase 4

• 1 other identifier: XRP4563A_4001
• Study Type: interventional
• Target: 251
• Locations: 1 country
• Sites: 1

Brief Summary

Study objectives :

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

Conditions

Venous Thrombosis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

1

EXPERIMENTAL

enoxaparin

Drug: enoxaparin

Interventions

enoxaparin 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.

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-Aventis Administrative Office

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Venous Thrombosis

Interventions

Enoxaparin

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Edibe Taylan

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 14, 2005
• First Posted: December 15, 2005
• Study Start: December 1, 2004
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: February 3, 2010

Record last verified: 2010-02

Locations

TU (1)