Clinical trial NCT00338897: Dose Ranging Study in Elective Total Hip Replacement Surgery
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Venous Thromboembolism
Keywords: Venous Thromboembolism
Prevention
Arthroplasty
Replacement
Hip
orthopedic surgery
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2006-06-20
Enrollment: 1090
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The primary objective is to:

* demonstrate the efficacy of SR123781A in the prevention of venous thromboembolism (VTE) by the demonstration of a dose-response in patients undergoing total hip replacement surgery.

The secondary objectives are to:

* evaluate the safety of SR123781A in the prevention of VTE after elective total hip replacement surgery; and
* to assess the SR123781A pharmacokinetic profile in patients undergoing elective total hip replacement surgery.


Eligibility criteria: Inclusion Criteria:

* Patients scheduled to undergo 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

Exclusion Criteria:

* 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
* Known progressive malignant disease
* Ischemic stroke in the last 3 months
* Myocardial infarction (MI) in the last 3 months
* Any major orthopedic surgery in the 3 months prior to study start
* Clinical signs or symptoms of DVT or PE within the last 12 months or symptoms of post phlebitic syndrome (these conditions may confound DVT/PE assessments)
* Treatment with other antithrombotic agents within 7 days prior to surgery

Primary outcomes:
measure: The primary efficacy endpoint is a composite of total venous thromboembolic events (VTE) including VTE related deaths during the treatment period.
Secondary outcomes:
measure: Secondary efficacy endpoints will include all deep vein thrombosis events [DVTs] (proximal or distal) and all symptomatic VTEs (pulmonary embolisms [PEs] or DVTs)
measure: The main safety criterion is the incidence of major bleedings occurring from the first study drug administration to 3 calendar days after the last study drug administration.
Other outcomes:
Locations:
city: San Isidro
country: Argentina
facility: Sanofi-Aventis
state: Buenos Aires
city: Sofia
country: Bulgaria
facility: Sanofi-Aventis
city: Providencia
country: Chile
facility: Sanofi-Aventis
state: Santiago
city: Santafe de Bogota
country: Colombia
facility: Sanofi-Aventis
city: Praha
country: Czech Republic
facility: Sanofi-Aventis
city: Denmark
country: Denmark
facility: Sanofi-Aventis
city: Helsinki
country: Finland
facility: Sanofi-Aventis
city: Mexico
country: Mexico
facility: Sanofi-Aventis
city: Oslo
country: Norway
facility: Sanofi-Aventis
city: Warszawa
country: Poland
facility: Sanofi-Aventis
city: Bucuresti
country: Romania
facility: Sanofi-Aventis
city: Moscow
country: Russian Federation
facility: Sanofi-Aventis
city: Bromma
country: Sweden
facility: Sanofi-Aventis
city: Istanbul
country: Turkey
facility: Sanofi-Aventis
Study officials:
affiliation: Hoersholm Hospital, Spine Clinic, Usserod Kongevej 102, DK-2970 Hoerholm, Denmark
name: Michael Rud Lassen, MD
role: STUDY_CHAIR
References:
citation: Lassen MR, Dahl O, Mismetti P, Zielske D, Turpie AG. SR123781A: a new once-daily synthetic oligosaccharide anticoagulant for thromboprophylaxis after total hip replacement surgery: the DRIVE (Dose Ranging Study in Elective Total Hip Replacement Surgery) study. J Am Coll Cardiol. 2008 Apr 15;51(15):1498-504. doi: 10.1016/j.jacc.2008.03.007.