Clinical trial NCT00697099: Evaluation of AVE5026 as Compared to Enoxaparin for the Prevention of Thromboembolism in Patients Undergoing Total Hip Replacement Surgery
Official title: A Multinational, Multicenter, Randomized, Double-Blind Study Comparing the Efficacy and Safety of AVE5026 With Enoxaparin for the Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Hip Replacement Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Venous Thromboembolism
Keywords: VTE prevention
Total Hip Replacement
Heparin Low-Molecular-Weight
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-06-13
Enrollment: 2326
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 was to compare the efficacy of once daily \[q.d.\] subcutaneous \[s.c.\] injections of Semuloparin sodium (AVE5026) with q.d. s.c. injections of enoxaparin for the prevention of Venous Thromboembolic Events \[VTE\] in patients undergoing elective total hip replacement surgery.

The secondary objectives were to evaluate the safety of AVE5026 in patients undergoing elective total hip replacement surgery, and to document AVE5026 exposure in this population.

Detailed description: Randomization had to take place just prior the first study drug injection (randomization ratio 1:1).

The total duration of observation per participant was 35-42 days from surgery broken down as follows:

* 7 to 10-day double-blind treatment period;
* 28 to 35-day follow-up period.

Mandatory bilateral venography of the lower limbs had to be performed 7 to 11 days after surgery.

Eligibility criteria: Inclusion Criteria:

* Elective total hip replacement surgery or a revision of at least one component of a prosthesis implanted ≥ 6 months prior to study entry.

Exclusion Criteria:

* Any major orthopedic surgery in the 3 months prior to study start;
* Deep vein thrombosis or pulmonary embolism within the last 12 months or known post-phlebitic syndrome;
* High risk of bleeding;
* Known allergy to heparin or enoxaparin;
* Any contra-indications to the performance of venography;
* End stage renal disease or patient on dialysis.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Percentage of Participants Who Experienced Venous Thromboembolism Event [VTE] or Death From Any Cause
timeFrame: From randomization up to 10 days after surgery or the day of mandatory venography, whichever came first
Secondary outcomes:
measure: Percentage of Participants Who Experienced "Major" VTE or All-cause Death
timeFrame: From randomization up to 10 days after surgery or the day of mandatory venography, whichever came first
measure: Percentage of Participants Who Experienced Clinically Relevant Bleedings
timeFrame: From first study drug injection up to 3 days after last study drug injection
measure: Percentage of Participants Who Required the Initiation of Curative Anticoagulant or Thrombolytic Treatment After VTE Assessment
timeFrame: From randomization up to 10 days after surgery or the day of mandatory venography, whichever came first
Other outcomes:
measure: Overview of deaths
timeFrame: From first study drug injection up to 3 days after last study drug injection
measure: Platelets Count: Percentage of Participants With Potentially Clinically Significant Abnormalities [PCSA]
timeFrame: From first study drug injection up to 3 days after last study drug injection
measure: Liver Function: Percentage of Participants With Potentially Clinically Significant Abnormalities [PCSA]
timeFrame: From first study drug injection up to 3 days after last study drug injection
Locations:
city: Bridgewater
country: United States
facility: Sanofi-Aventis Administrative Office
state: New Jersey
city: Buenos Aires
country: Argentina
facility: Sanofi-Aventis Administrative Office
city: Macquarie Park
country: Australia
facility: sanofi-aventis Australia & New Zealand administrative office
state: New South Wales
city: Minsk
country: Belarus
facility: Sanofi-Aventis Administrative Office
city: Laval
country: Canada
facility: Sanofi-Aventis Administrative Office
city: Santiago
country: Chile
facility: Sanofi-Aventis Administrative Office
city: Santafe de Bogota
country: Colombia
facility: Sanofi-Aventis Administrative Office
city: Praha
country: Czech Republic
facility: Sanofi-Aventis Administrative Office
city: Horsholm
country: Denmark
facility: Sanofi-Aventis Administrative Office
city: Tallinn
country: Estonia
facility: Sanofi-Aventis Administrative Office
city: Helsinki
country: Finland
facility: Sanofi-Aventis Administrative Office
city: Berlin
country: Germany
facility: Sanofi-Aventis Administrative Office
city: Athens
country: Greece
facility: Sanofi-Aventis Administrative Office
city: Mumbai
country: India
facility: Sanofi-Aventis Administrative Office
city: Milano
country: Italy
facility: Sanofi-Aventis Administrative Office
city: Mexico
country: Mexico
facility: Sanofi-Aventis Administrative Office
city: Lysaker
country: Norway
facility: Sanofi-Aventis Administrative Office
city: Lima
country: Peru
facility: Sanofi-Aventis Administrative Office
city: Makati City
country: Philippines
facility: Sanofi-Aventis Administrative Office
city: Warszawa
country: Poland
facility: Sanofi-Aventis Administrative Office
city: Bucuresti
country: Romania
facility: Sanofi-Aventis Administrative Office
city: Moscow
country: Russian Federation
facility: Sanofi-Aventis Administrative Office
city: Brastislava
country: Slovakia
facility: Sanofi-Aventis Administrative Office
city: Midrand
country: South Africa
facility: Sanofi-Aventis Administrative Office
city: Barcelona
country: Spain
facility: Sanofi-Aventis Administrative Office
city: Bromma
country: Sweden
facility: Sanofi-Aventis Administrative Office
city: Taipei
country: Taiwan
facility: Sanofi-Aventis Administraive Office
city: Bangkok
country: Thailand
facility: Sanofi-Aventis Administrative Office
city: Istanbul
country: Turkey
facility: Sanofi-Aventis Administrative Office
city: Kiev
country: Ukraine
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Orthopädische Klinik, Stätische Klinik, Gotenstrasse 6-8, Frankfurt Höechst, 65929 Frankfurt, Germany
name: Patrick MOURET, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: HHS-General Hospital, Hamilton, Ontario, Canada
name: Alexander G. TURPIE, MD
role: STUDY_CHAIR
References:
citation: Lassen MR, Fisher W, Mouret P, Agnelli G, George D, Kakkar A, Mismetti P, Turpie AG; SAVE Investigators. Semuloparin for prevention of venous thromboembolism after major orthopedic surgery: results from three randomized clinical trials, SAVE-HIP1, SAVE-HIP2 and SAVE-KNEE. J Thromb Haemost. 2012 May;10(5):822-32. doi: 10.1111/j.1538-7836.2012.04701.x.