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 surgeryMedDRA version: 8.1Level: LLTClassification code 10049909
- Registration Number
- EUCTR2006-000152-41-CZ
- Lead Sponsor
- sanofi-aventis recherche & developpement
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1020
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
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
- Primary Outcome Measures
Name Time Method Main Objective: To demonstrate the efficacy of SR123781A in the prevention of Venous Thromboembolism (DVTand/or PE) via demonstration of a dose-response in patients undergoing total hip replacement surgery;Secondary Objective: To evaluate the safety (incidence of major bleeding) of SR123781A in the prevention of VTE after elective total hip replacement surgery<br>To assess the SR123781 pharmacokinetic profile in patients undergoing elective total hip replacement surgery;Primary end point(s): The primary efficacy endpoint is a composite of the following VTE outcome events:<br>• Any DVT identified on mandatory venography of the lower limbs performed between day 5 and day 11<br>• Confirmed DVT and/or non-fatal PE in case of symptoms earlier than the date of the mandatory venography<br>• VTE related deaths (Fatal PE and unexplained death) before the mandatory examination
- Secondary Outcome Measures
Name Time Method