Clinical trial NCT00709904: Evaluation of AVE5026 as Compared to Placebo for the Extended Prophylaxis of Venous Thromboembolism in Patients Having Undergone Hip Fracture Surgery
Official title: A Multinational, Multicenter, Randomized, Double-Blind Study Comparing the Efficacy and Safety of AVE5026 With Placebo for the Extended Prevention of Venous Thromboembolism in Patients Having Undergone Hip Fracture Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Venous Thromboembolism
Keywords: venous thromboprophylaxis
primary prevention
orthopedic surgery
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-07-03
Enrollment: 469
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 evaluate the efficacy of once daily (QD) subcutaneous (SC) injections of Semuloparin sodium (AVE5026) versus placebo for 3 additional weeks following an initial 7 to 10-day venous thromboprophylaxis with open-label AVE5026 in patients having undergone hip fracture surgery.

The secondary objective is to evaluate the safety of extended AVE5026 administration.

Detailed description: The total duration of observation per participant is 56-63 days from surgery broken down as follows:

* 7 to 10-day initial treatment period with open-label Semuloparin sodium;
* Randomization;
* 19 to 23-day double-blind treatment period with Semuloparin sodium or placebo;
* 30-day follow-up period.

Mandatory bilateral venography of the lower limbs is to be performed between 19 and 24 days after randomization.

Eligibility criteria: Inclusion Criteria:

* In the run-in phase:

  * Standard surgery for fracture of the upper third of the femur, including femoral head and neck
* In the double-blind phase following the run-in phase:

  * Completion of the run-in phase without permanent treatment discontinuation

Exclusion Criteria:

* Any major orthopedic surgery within 3 months prior to enrolment;
* Deep vein thrombosis or pulmonary embolism within the last 12 months, or known post-phlebitic syndrome;
* High risk of bleeding;
* Known hypersensitivity to heparins;
* Any contraindication 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 Experience Venous Thromboembolism Events (VTE) or Death From Any Cause During the Extension Treatment Period
timeFrame: From randomization up to 24 days after randomization or the day of mandatory venography, whichever comes first
Secondary outcomes:
measure: Percentage of Participants Who Experience "Major" VTE or Death From Any Cause
timeFrame: From randomization up to 24 days after randomization or the day of mandatory venography, whichever comes first
measure: Percentage of Participants Who Experience Clinically Relevant Bleedings During the Extension Treatment Period
timeFrame: From 1st study drug injection in the extension treatment period up to 3 days after last study drug injection
measure: Percentage of Participants Who Require the Initiation of Curative Anticoagulant or Thrombolytic Treatment After VTE Assessment During the Extension Treatment Period
timeFrame: From randomization up to 24 days after randomization or the day of mandatory venography, whichever comes first
Other outcomes:
measure: Overview of Reported Bleeding Adverse Event
timeFrame: From 1st study drug injection up to 3 days after last study drug injection
measure: Overview of Deaths
timeFrame: From 1st 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 1st 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 1st 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: 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: Shangaï
country: China
facility: Sanofi-Aventis Administrative Office
city: Santafe de Bogota
country: Colombia
facility: Sanofi-Aventis Administrative Office
city: Cairo
country: Egypt
facility: Sanofi-Aventis Administrative Office
city: Mumbai
country: India
facility: Sanofi-Aventis Administrative Office
city: Seoul
country: Korea, Republic of
facility: Sanofi-Aventis Administrative Office
city: Vilnius
country: Lithuania
facility: Sanofi-Aventis Administrative Office
city: Mexico
country: Mexico
facility: Sanofi-Aventis Administrative Office
city: Lima
country: Peru
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: Istanbul
country: Turkey
facility: Sanofi-Aventis Administrative Office
city: Kiev
country: Ukraine
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: McGill University Health Centre, Montreal, Quebec, Canada
name: William D. Fisher, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: HHS-General Hospital, Hamilton, Ontario, Canada
name: Alexander G. Turpie, MD
role: STUDY_CHAIR
References:
citation: Fisher WD, Agnelli G, George DJ, Kakkar AK, Lassen MR, Mismetti P, Mouret P, Turpie AG. Extended venous thromboembolism prophylaxis in patients undergoing hip fracture surgery - the SAVE-HIP3 study. Bone Joint J. 2013 Apr;95-B(4):459-66. doi: 10.1302/0301-620X.95B4.30730.