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
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Sanofi
- Enrollment
- 469
- Locations
- 1
- Primary Endpoint
- Percentage of Participants Who Experience Venous Thromboembolism Events (VTE) or Death From Any Cause During the Extension Treatment Period
Study Overview
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.
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
- •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.
Arms & Interventions
Semuloparin extension treatment
Extension treatment with Semuloparin sodium 20 mg (10 mg if SRI) for 19-23 days following initial treatment with open-label Semuloparin 20 mg (10 mg if SRI) for 7-10 days.
Intervention: Open-label Semuloparin sodium (Drug)
Semuloparin extension treatment
Extension treatment with Semuloparin sodium 20 mg (10 mg if SRI) for 19-23 days following initial treatment with open-label Semuloparin 20 mg (10 mg if SRI) for 7-10 days.
Intervention: Semuloparin sodium (Drug)
Placebo extension treatment
Extension treatment with placebo (for Semuloparin sodium) for 19-23 days following initial treatment with open-label Semuloparin 20 mg (10 mg if SRI) for 7-10 days
Intervention: Open-label Semuloparin sodium (Drug)
Placebo extension treatment
Extension treatment with placebo (for Semuloparin sodium) for 19-23 days following initial treatment with open-label Semuloparin 20 mg (10 mg if SRI) for 7-10 days
Intervention: Placebo (for Semuloparin sodium) (Drug)
Outcomes
Primary Outcomes
Percentage of Participants Who Experience Venous Thromboembolism Events (VTE) or Death From Any Cause During the Extension Treatment Period
Time Frame: From randomization up to 24 days after randomization or the day of mandatory venography, whichever comes first
VTE include any Deep Vein Thrombosis (DVT) (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 suspected VTE. All-cause deaths include fatal PE and deaths for other reason than PE.
Secondary Outcomes
- Percentage of Participants Who Experience "Major" VTE or Death From Any Cause(From randomization up to 24 days after randomization or the day of mandatory venography, whichever comes first)
- Percentage of Participants Who Experience Clinically Relevant Bleedings During the Extension Treatment Period(From 1st study drug injection in the extension treatment period up to 3 days after last study drug injection)
- Percentage of Participants Who Require the Initiation of Curative Anticoagulant or Thrombolytic Treatment After VTE Assessment During the Extension Treatment Period(From randomization up to 24 days after randomization or the day of mandatory venography, whichever comes first)