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 primary prevention of Venous Thromboembolic Events \[VTE\] in patients hospitalized for acute medical illness. The secondary objectives were to evaluate the safety of AVE5026 and to document AVE5026 exposure in this population.
Randomization had to take place just prior to the first study drug injection. The total duration of observation per participant was 35-42 days from randomization broken down as follows: * 10 to 14-day double-blind treatment period; * 25 to 32-day follow-up period. Mandatory bilateral compression ultrasound \[CUS\] had to be performed between 10 to 15 days after randomization.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
421
0.4 mL (0.2 mL if SRI) solution in ready-to-use 0.5 ml pre-filled syringe Subcutaneous injection
0.4 mL (0.2 mL if SRI) solution in ready-to-use 0.5 ml pre-filled syringe Subcutaneous injection
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Percentage of Participants Who Experienced Venous Thromboembolism Event (VTE) or VTE-related Death
VTE included: * asymptomatic proximal Deep Vein Thrombosis (DVT) detected by the mandatory CUS and confirmed by a Compression Ultrasound Adjudication Committee (CUSAC) after central and blind review of the mandatory CUS; * symptomatic DVT and non-fatal Pulmonary Embolism (PE) reported by the investigator and confirmed by a Central Independent Adjudication Committee (CIAC) after central and blind review of diagnosis tests. VTE-related Death included fatal PE and unexplained deaths.
Time frame: From randomization up to 15 days after randomization or the day of the mandatory Compression Ultrasound (CUS), whichever came first
Percentage of Participants Who Experienced asymptomatic proximal DVT
Time frame: From randomization up to 15 days after randomization or the day of the mandatory CUS, whichever came first.
Percentage of Participants Who Experienced Clinically Relevant Bleedings
Bleedings were centrally and blindly reviewed by the CIAC and classified as: * "major" (fatal, symptomatic in a critical area/organ, causing a post-operative drop in hemoglobin ≥2 g/dL or requiring post-operative transfusion ≥2 units of blood); * "clinically relevant non-major" (overt bleeding requiring medical intervention and not meeting criteria for major bleeding); * "Non-clinically relevant bleeding".
Time frame: From 1st 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
Initiation of curative anticoagulant or thrombolytic treatment after VTE assessment was defined from investigator's answer to the question "was the subject treated for VTE?" asked after the diagnostic tests for suspected VTE and after the mandatory CUS.
Time frame: From randomization up to 15 days after randomization or the day of mandatory CUS, whichever came first
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