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
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Sanofi
- Enrollment
- 1,003
- Locations
- 1
- Primary Endpoint
- Percentage of Participants Who Experienced Venous Thromboembolism Event [VTE] or All-cause Death
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Semuloparin
Semuloparin sodium 20 mg (10 mg if Severe Renal Impairment [SRI]) once daily for 7-10 days with an initial dose given 8 hours after surgery
Placebo for Enoxaparin sodium prior to surgery according to local standard for Enoxaparin and 12 hours after surgery to maintain the blind
Intervention: Semuloparin sodium (Drug)
Semuloparin
Semuloparin sodium 20 mg (10 mg if Severe Renal Impairment [SRI]) once daily for 7-10 days with an initial dose given 8 hours after surgery
Placebo for Enoxaparin sodium prior to surgery according to local standard for Enoxaparin and 12 hours after surgery to maintain the blind
Intervention: Placebo (Drug)
Enoxaparin
Enoxaparin sodium 40 mg (20 mg if Severe Renal Impairment [SRI]) once daily for 7-10 days with an initial dose given prior to or 12 hours after surgery according to local standard for Enoxaparin sodium
Placebo for Semuloparin sodium 8 hours after surgery to maintain the blind
Intervention: Enoxaparin sodium (Drug)
Enoxaparin
Enoxaparin sodium 40 mg (20 mg if Severe Renal Impairment [SRI]) once daily for 7-10 days with an initial dose given prior to or 12 hours after surgery according to local standard for Enoxaparin sodium
Placebo for Semuloparin sodium 8 hours after surgery to maintain the blind
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Percentage of Participants Who Experienced Venous Thromboembolism Event [VTE] or All-cause Death
Time Frame: From randomization up to 10 days after surgery or the day of mandatory venography, whichever came first
VTE included any Deep Vein Thrombosis \[DVT\] (proximal or distal, symptomatic or not) and non-fatal Pulmonary Embolism \[PE\] as confirmed by a Central Independent Adjudication Committee \[CIAC\] after review of mandatory bilateral venograms and diagnostic tests for VTE. All-cause deaths included fatal PE and deaths for other reason than PE.
Secondary Outcomes
- Percentage of Participants Who Experienced "Major" VTE or All-cause Death(From randomization up to 10 days after surgery or the day of mandatory venography, whichever came first)
- Percentage of Participants Who Experienced Clinically Relevant Bleedings(From first study drug injection up to 3 days after last study drug injection)
- Percentage of Participants Who Required the Initiation of Curative Anticoagulant or Thrombolytic Treatment After VTE Assessment(From randomization up to 10 days after surgery or the day of mandatory venography, whichever came first)