A multicenter, Randomized, Double Blind, Double Dummy, Parallel Group, Dose Ranging Study of subcutaneous SR123781A with an Enoxaparin calibrator arm in the Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Hip Replacement surgery - DRIVE

• Conditions: prevention of VTE in patients undergoing elective total hip replacement surgery; MedDRA version: 8.1Level: LLTClassification code 10049909

• Registration Number: EUCTR2006-000152-41-SE
• Lead Sponsor: sanofi-aventis recherche développement

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03-13
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1020

Inclusion Criteria

Age = 18 years
Undergoing elective total hip replacement surgery or a revision of at least one component of a total hip replacement performed = 6 months prior to study entry
Written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Related to study methodology
o Pregnant or nursing women, or women of childbearing potential who are not
using an effective contraceptive method and who do not have a negative
pregnancy test performed immediately before randomization
o Treatment with any investigational product or investigational device in the last
30 days prior to randomization
o Current addictive disorders that could interfere with study participation
o Known progressive malignant disease
o Ischemic stroke, myocardial infarction, any major orthopedic surgeryin the last 3 months
o Clinical signs or symptoms of DVT or PE within the last 12 months or
symptoms of post phlebitic syndrome
o Treatment with other antithrombotic agents within 7 days prior to surgery
o Serum creatinine > 2 mg/dL (180 µmol/L) in a well hydrated patient
o Significant anemia (Hb < 10 g/dL)
o Known sensitivity to iodine or contrast dyes
o Use of any contraindicated drug that cannot be combined with the injection of
contrast medium, e.g. antihyperglycemic drug metformin
Related to the active calibrator
o Any contra-indication or history of hypersensitivity to UFH or LMWH
o Past or present bleeding disorder
o Active or recent (<3 months) significant bleeding, including gastrointestinal
bleeding or peptic ulcer
o Uncontrolled arterial hypertension
o Any history of hemorrhagic stroke
o Known structural damage or other pathologic process involving the central
nervous system
o Recent (<3 months) trauma, major surgery, ophthalmic surgery or parenchymal
organ biopsy
o Thrombocytopenia
o History of heparin induced thrombocytopenia

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified