Clinical trial NCT00721760: Evaluation of AVE5026 as Compared to Enoxaparin for the Prevention of Thromboembolism in Patients Undergoing Hip Fracture 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 Hip Fracture Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Venous Thromboembolism
Keywords: Hip fractures
Heparin Low-Molecular-Weight
Randomized Controlled Trial
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-07-24
Enrollment: 1003
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 hip fracture surgery.

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

Detailed description: Randomization had to take place just prior to 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 between 7 to 11 days after surgery.

Eligibility criteria: Inclusion Criteria:

* Standard surgery for fracture of the upper third of the femur including femoral head and neck.

Exclusion Criteria:

* Estimated time of injury/fracture \> 24 hours before admission to hospital;
* Any major orthopedic surgery in the 3 months prior to study start;
* Multiple trauma affecting more than one organ system;
* 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, or pork products;
* 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 All-cause Death
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: Minsk
country: Belarus
facility: Sanofi-Aventis Administrative Office
city: Sofia
country: Bulgaria
facility: Sanofi-Aventis Administrative Office
city: Laval
country: Canada
facility: Sanofi-Aventis Administrative Office
city: Santiago
country: Chile
facility: Sanofi-Aventis Administrative Office
city: Shangaï
country: China
facility: Sanofi-Aventis Administrative Office
city: 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: Helsinki
country: Finland
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: Lima
country: Peru
facility: Sanofi-Aventis Administrative Office
city: Warszawa
country: Poland
facility: Sanofi-Aventis Administrative Office
city: Porto Salvo
country: Portugal
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: 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: Istanbul
country: Turkey
facility: Sanofi-Aventis Administrative Office
city: Kiev
country: Ukraine
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Department of Orthopaedic Surgery, McGill University Health Centre, 1650 Cedar Avenue, Montreal, Quebec, H3G 1A4, Canada
name: William D. Fisher, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: McMaster University
name: Alexander G. Turpie
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.