Venous Thromboembolism
Conditions
Keywords
Venous thrombosis, Primary 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 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.
Detailed description
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.
Interventions
0.4 mL (0.2 mL if SRI) solution in ready-to-use 0.5 ml pre-filled syringe Subcutaneous injection
DRUGEnoxaparin sodium
0.4 mL (0.2 mL if SRI) solution in ready-to-use 0.5 ml pre-filled syringe Subcutaneous injection
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patient with an acute medical condition requiring bed rest for at least 3 days, and hospitalized for at least one of the following medical conditions: * Congestive heart failure (New York Heart Association \[NYHA\] class III/IV); * Acute respiratory failure (not requiring mechanical ventilation); * Acute infection (without septic shock)\*; * Acute rheumatic disorder\*; * Acute episode of inflammatory bowel disease\*. * Patient with one of these conditions should have at least one additional risk factor for venous thromboembolism (VTE) among the following: * Age ≥ 75 years; * Active cancer or myeloproliferative disorders (having received treatment for cancer within the last 6 months); * Previous VTE; * Obesity; * Oral hormone therapy (antiandrogen or estrogen); * Chronic heart failure; * Chronic respiratory failure.
Exclusion criteria
* Previous surgery with general anesthesia within 30 days before inclusion in the study; * Patient requiring a curative anticoagulant or thrombolytic treatment; * Patient at risk of bleeding; * Stroke; * Known hypersensitivity to heparin or enoxaparin sodium; * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Experienced Venous Thromboembolism Event (VTE) or VTE-related Death | From randomization up to 15 days after randomization or the day of the mandatory Compression Ultrasound (CUS), whichever came first | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Experienced asymptomatic proximal DVT | 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 | From 1st study drug injection up to 3 days after last study drug injection | 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. |
| Percentage of Participants Who Required the Initiation of Curative Anticoagulant or Thrombolytic Treatment After VTE Assessment | From randomization up to 15 days after randomization or the day of mandatory CUS, whichever came first | 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. |
Countries
Australia, Austria, Canada, Czechia, Estonia, France, Germany, Hungary, India, Italy, Latvia, Lithuania, Mexico, Netherlands, New Zealand, Romania, Russia, South Korea, Spain, Ukraine, United Kingdom, United States
Outcome results
None listed