Evaluation of AVE5026 as Compared to Enoxaparin for the Prevention of Venous Thromboembolism in Patients Undergoing Major Abdominal Surgery
- Conditions
- Venous Thromboembolism
- Interventions
- Registration Number
- NCT00679588
- Lead Sponsor
- Sanofi
- Brief Summary
The primary objective is to compare the efficacy and safety 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 major abdominal surgery.
The secondary objectives are to evaluate the safety of Semuloparin sodium (AVE5026) and to document Semuloparin sodium (AVE5026) exposure in this population.
- Detailed Description
Randomization has to take place prior to the surgery.
The total duration of observation per participant is 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 has to be performed between 7 to 11 days after surgery.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 4413
-
Patient undergoing major abdominal surgery (open surgery under general anesthesia lasting more than 45 minutes in the peritoneal and/or retroperitoneal space and/or pelvis).
-
Patient <60 years of age had to have one of the following additional risk factors for VTE:
- History of VTE,
- Obesity,
- Chronic Heart failure,
- Chronic Respiratory Failure,
- Inflammatory Bowel Disease,
- Cancer Surgery.
- Any major orthopedic or general surgery in the 3 months prior to study start;
- Clinical signs or symptoms of DVT or PE within the last 12 months or known post phlebitic syndrome;
- Any contra-indications to the performance of venography;
- High risk of bleeding;
- Known hypersensitivity to heparin or Enoxaparin sodium;
- End stage renal disease or patient on dialysis.
The above information was not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Semuloparin Semuloparin Sodium 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) Semuloparin Placebo 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) Enoxaparin Enoxaparin sodium 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) Enoxaparin Placebo 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)
- Primary Outcome Measures
Name Time Method Percentage of Participants Who Experience Venous Thromboembolism Event (VTE) or All-cause Death From randomization up to 10 days after surgery or the day of mandatory venography, whichever comes first VTE includes any proximal or distal 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 VTE.
All-cause deaths includes fatal PE and deaths for other reason than PE.
- Secondary Outcome Measures
Name Time Method Percentage of Participants Who Experience "major" VTE or All-cause Death From randomization up to 10 days after surgery or the day of mandatory venography, whichever comes first "major" VTE includes any proximal DVT, symptomatic distal DVT and non-fatal Pulmonary Embolism (PE) as as confirmed by the CIAC.
Percentage of Participants Who Experience Clinically Relevant Bleedings ("major" and "clinically relevant non-major" bleedings ) From 1st study drug injection up to 3 days after last study drug injection Bleedings are centrally and blindly reviewed by the CIAC and classified as:
* "major" (fatal, in a critical area/organ, causing a post-operative drop in hemoglobin ≥2 g/dL or requiring post-operative transfusion ≥2 units of blood, leading to an invasive diagnostic or therapeutic intervention, or associated with circulatory decompensation);
* "clinically relevant non-major" (skin hematoma or epistaxis requiring surgical/medical intervention/treatment, macroscopic hematuria, or overt bleeding requiring specific attention by health care professional);
* "Nonclinically relevant bleeding".Percentage of Participants requiring 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 comes 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 venography.
Trial Locations
- Locations (270)
Investigational Site Number 840036
🇺🇸Springfield, Illinois, United States
Investigational Site Number 840007
🇺🇸Huntingdon Beach, California, United States
Investigational Site Number 840017
🇺🇸Jacksonville, Florida, United States
Investigational Site Number 840009
🇺🇸Columbus, Georgia, United States
Investigational Site Number 032001
🇦🇷Buenos Aires, Argentina
Investigational Site Number 032008
🇦🇷Capital Federal, Argentina
Investigational Site Number 840031
🇺🇸Corlton, California, United States
Investigational Site Number 356004
🇮🇳Ahmedabad, India
Investigational Site Number 356006
🇮🇳Coimbatore, India
Investigational Site Number 642003
🇷🇴Cluj-Napoca, Romania
Investigational Site Number 710001
🇿🇦Cape Town, South Africa
Investigational Site Number 642002
🇷🇴Timisoara, Romania
Investigational Site Number 643019
🇷🇺Krasnodar, Russian Federation
Investigational Site Number 643015
🇷🇺Sestroretsk,, Russian Federation
Investigational Site Number 710003
🇿🇦Worcester, South Africa
Investigational Site Number 752002
🇸🇪Kungälv, Sweden
Investigational Site Number 792003
🇹🇷Istanbul, Turkey
Investigational Site Number 642005
🇷🇴Cluj-Napoca, Romania
Investigational Site Number 643026
🇷🇺Omsk, Russian Federation
Investigational Site Number 724002
🇪🇸Madrid, Spain
Investigational Site Number 642001
🇷🇴Oradea, Romania
Investigational Site Number 643006
🇷🇺Krasnoyarsk, Russian Federation
Investigational Site Number 752003
🇸🇪Varberg, Sweden
Investigational Site Number 643007
🇷🇺Novosibirsk, Russian Federation
Investigational Site Number 643010
🇷🇺St. Petersburg, Russian Federation
Investigational Site Number 643009
🇷🇺St.-Petersburg, Russian Federation
Investigational Site Number 792006
🇹🇷Istanbul, Turkey
Investigational Site Number 688002
🇷🇸Novi Sad, Serbia
Investigational Site Number 705001
🇸🇮Celje, Slovenia
Investigational Site Number 792001
🇹🇷Istanbul, Turkey
Investigational Site Number 724001
🇪🇸Barcelona, Spain
Investigational Site Number 710004
🇿🇦Cape Town, South Africa
Investigational Site Number 804010
🇺🇦Donetsk, Ukraine
Investigational Site Number 826001
🇬🇧London, United Kingdom
Investigational Site Number 156008
🇨🇳Qingdao, China
Investigational Site Number 156014
🇨🇳Tianjin, China
Investigational Site Number 112001
🇧🇾Gomel, Belarus
Investigational Site Number 152002
🇨🇱Rancagua, Chile
Investigational Site Number 203015
🇨🇿Kolin, Czech Republic
Investigational Site Number 233003
🇪🇪Tallinn, Estonia
Investigational Site Number 356027
🇮🇳Bangalore, India
Investigational Site Number 356001
🇮🇳Mangalore, India
Investigational Site Number 616003
🇵🇱Bydgoszcz, Poland
Investigational Site Number 616011
🇵🇱Torun, Poland
Investigational Site Number 604006
🇵🇪Lima, Peru
Investigational Site Number 616010
🇵🇱Lublin, Poland
Investigational Site Number 616008
🇵🇱Wroclaw, Poland
Investigational Site Number 642006
🇷🇴Cluj-Napoca, Romania
Investigational Site Number 643008
🇷🇺Novosibirsk, Russian Federation
Investigational Site Number 643016
🇷🇺Vsevolozhsk, Russian Federation
Investigational Site Number 643020
🇷🇺Moscow, Russian Federation
Investigational Site Number 643021
🇷🇺Moscow, Russian Federation
Investigational Site Number 643018
🇷🇺St-Petersburg, Russian Federation
Investigational Site Number 688001
🇷🇸Belgrade, Serbia
Investigational Site Number 643012
🇷🇺Tomsk, Russian Federation
Investigational Site Number 688004
🇷🇸Belgrade, Serbia
Investigational Site Number 703001
🇸🇰Bratislava, Slovakia
Investigational Site Number 705002
🇸🇮Maribor, Slovenia
Investigational Site Number 804003
🇺🇦Cherkasy, Ukraine
Investigational Site Number 804007
🇺🇦Donetsk, Ukraine
Investigational Site Number 804011
🇺🇦Kharkiv, Ukraine
Investigational Site Number 804004
🇺🇦Kyiv, Ukraine
Investigational Site Number 752004
🇸🇪Norrköping, Sweden
Investigational Site Number 792007
🇹🇷Izmir, Turkey
Investigational Site Number 076007
🇧🇷Porto Alegre, Brazil
Investigational Site Number 124010
🇨🇦Montreal, Canada
Investigational Site Number 124009
🇨🇦Saint John, Canada
Investigational Site Number 124002
🇨🇦Thunder Bay, Canada
Investigational Site Number 124007
🇨🇦Vancouver, Canada
Investigational Site Number 276018
🇩🇪Castrop-Rauxel, Germany
Investigational Site Number 276006
🇩🇪Dresden, Germany
Investigational Site Number 840026
🇺🇸Birmingham, Alabama, United States
Investigational Site Number 840035
🇺🇸Birmingham, Alabama, United States
Investigational Site Number 840042
🇺🇸Birmingham, Alabama, United States
Investigational Site Number 840002
🇺🇸Birmingham, Alabama, United States
Investigational Site Number 840014
🇺🇸Los Angeles, California, United States
Investigational Site Number 840021
🇺🇸Denver, Colorado, United States
Investigational Site Number 840029
🇺🇸Clearwater, Florida, United States
Investigational Site Number 840044
🇺🇸Miami, Florida, United States
Investigational Site Number 840051
🇺🇸Columbus, Ohio, United States
Investigational Site Number 840025
🇺🇸Houston, Texas, United States
Investigational Site Number 840006
🇺🇸Pittsburgh, Pennsylvania, United States
Investigational Site Number 840050
🇺🇸Houston, Texas, United States
Investigational Site Number 840043
🇺🇸Morgantown, West Virginia, United States
Investigational Site Number 643003
🇷🇺Moscow, Russian Federation
Investigational Site Number 840011
🇺🇸Sant Barbara, California, United States
Investigational Site Number 840019
🇺🇸Maywood, Illinois, United States
Investigational Site Number 840037
🇺🇸Hazard, Kentucky, United States
Investigational Site Number 840008
🇺🇸St Louis, Missouri, United States
Investigational Site Number 840032
🇺🇸Lubbock, Texas, United States
Investigational Site Number 032007
🇦🇷Capital Federal, Argentina
Investigational Site Number 036002
🇦🇺Box Hill, Australia
Investigational Site Number 032004
🇦🇷Buenos Aires, Argentina
Investigational Site Number 040001
🇦🇹Graz, Austria
Investigational Site Number 040002
🇦🇹Wels, Austria
Investigational Site Number 032014
🇦🇷Córdoba, Argentina
Investigational Site Number 112006
🇧🇾Gomel, Belarus
Investigational Site Number 036003
🇦🇺Box Hill, Australia
Investigational Site Number 112004
🇧🇾Vitebsk, Belarus
Investigational Site Number 112007
🇧🇾Vitebsk, Belarus
Investigational Site Number 076003
🇧🇷Belo Horizonte, Brazil
Investigational Site Number 056002
🇧🇪Genk, Belgium
Investigational Site Number 056001
🇧🇪Gent, Belgium
Investigational Site Number 076014
🇧🇷Caxias Do Sul, Brazil
Investigational Site Number 076006
🇧🇷Goiania, Brazil
Investigational Site Number 076005
🇧🇷Curitiba, Brazil
Investigational Site Number 076011
🇧🇷Joinville, Brazil
Investigational Site Number 076015
🇧🇷Ribeirao Preto, Brazil
Investigational Site Number 076009
🇧🇷Porto Alegre, Brazil
Investigational Site Number 076013
🇧🇷Sao Jose Do Rio Preto, Brazil
Investigational Site Number 100003
🇧🇬Ruse, Bulgaria
Investigational Site Number 076004
🇧🇷Sao Paulo, Brazil
Investigational Site Number 100004
🇧🇬Pleven, Bulgaria
Investigational Site Number 076002
🇧🇷Sao Paulo, Brazil
Investigational Site Number 076008
🇧🇷Sao Paulo, Brazil
Investigational Site Number 100006
🇧🇬Varna, Bulgaria
Investigational Site Number 100011
🇧🇬Sofia, Bulgaria
Investigational Site Number 100008
🇧🇬Sofia, Bulgaria
Investigational Site Number 100010
🇧🇬Varna, Bulgaria
Investigational Site Number 124004
🇨🇦Kitchener, Canada
Investigational Site Number 124001
🇨🇦Edmonton, Canada
Investigational Site Number 156013
🇨🇳Haikou, China
Investigational Site Number 152001
🇨🇱Santiago, Chile
Investigational Site Number 124011
🇨🇦Red Deer, Canada
Investigational Site Number 156011
🇨🇳Baotou, China
Investigational Site Number 156012
🇨🇳Changsha, China
Investigational Site Number 156010
🇨🇳Changsha, China
Investigational Site Number 156006
🇨🇳Fuzhou, China
Investigational Site Number 156001
🇨🇳Shijiazhuang, China
Investigational Site Number 156003
🇨🇳Guangzhou, China
Investigational Site Number 156004
🇨🇳Xi'An, China
Investigational Site Number 203001
🇨🇿Brno, Czech Republic
Investigational Site Number 191004
🇭🇷Pozega, Croatia
Investigational Site Number 191001
🇭🇷Pula, Croatia
Investigational Site Number 203011
🇨🇿Jihlava, Czech Republic
Investigational Site Number 191002
🇭🇷Zagreb, Croatia
Investigational Site Number 203007
🇨🇿Brno, Czech Republic
Investigational Site Number 208002
🇩🇰Odense C, Denmark
Investigational Site Number 203014
🇨🇿Most, Czech Republic
Investigational Site Number 203012
🇨🇿Pardubice, Czech Republic
Investigational Site Number 203006
🇨🇿Praha 5, Czech Republic
Investigational Site Number 203002
🇨🇿Praha 6, Czech Republic
Investigational Site Number 276011
🇩🇪Bochum, Germany
Investigational Site Number 203003
🇨🇿Ostrava, Czech Republic
Investigational Site Number 276001
🇩🇪Stralsund, Germany
Investigational Site Number 208001
🇩🇰København Nv, Denmark
Investigational Site Number 276012
🇩🇪Hannover, Germany
Investigational Site Number 233002
🇪🇪Tartu, Estonia
Investigational Site Number 276015
🇩🇪Castrop-Rauxel, Germany
Investigational Site Number 300002
🇬🇷Heraklion, Greece
Investigational Site Number 276016
🇩🇪Magdeburg, Germany
Investigational Site Number 348007
🇭🇺Debrecen, Hungary
Investigational Site Number 276014
🇩🇪Lübeck, Germany
Investigational Site Number 348008
🇭🇺Szeged, Hungary
Investigational Site Number 356008
🇮🇳Bangalore, India
Investigational Site Number 356031
🇮🇳Bhopal, India
Investigational Site Number 356018
🇮🇳Chennai, India
Investigational Site Number 356014
🇮🇳Chennai, India
Investigational Site Number 356021
🇮🇳Chennai, India
Investigational Site Number 356016
🇮🇳Chennai, India
Investigational Site Number 356022
🇮🇳Jaipur, India
Investigational Site Number 356010
🇮🇳Hyderabad, India
Investigational Site Number 356002
🇮🇳Jaipur, India
Investigational Site Number 356007
🇮🇳Kochi, India
Investigational Site Number 356032
🇮🇳Ludhiana, India
Investigational Site Number 356003
🇮🇳Luknow, India
Investigational Site Number 380009
🇮🇹Aviano, Italy
Investigational Site Number 380001
🇮🇹Genova, Italy
Investigational Site Number 356012
🇮🇳Punjgutta, India
Investigational Site Number 356023
🇮🇳Pune, India
Investigational Site Number 356015
🇮🇳Pune, India
Investigational Site Number 356009
🇮🇳New Delhi, India
Investigational Site Number 380015
🇮🇹Genova, Italy
Investigational Site Number 380006
🇮🇹Milano, Italy
Investigational Site Number 380004
🇮🇹Padova, Italy
Investigational Site Number 380012
🇮🇹Pordenone, Italy
Investigational Site Number 380013
🇮🇹Piacenza, Italy
Investigational Site Number 380008
🇮🇹Parma, Italy
Investigational Site Number 410001
🇰🇷Gyeonggi-do, Korea, Republic of
Investigational Site Number 410009
🇰🇷Incheon, Korea, Republic of
Investigational Site Number 380007
🇮🇹Trieste, Italy
Investigational Site Number 380005
🇮🇹Reggio Emilia, Italy
Investigational Site Number 380011
🇮🇹San Donato Milanese, Italy
Investigational Site Number 410004
🇰🇷Seoul, Korea, Republic of
Investigational Site Number 410006
🇰🇷Goyang, Korea, Republic of
Investigational Site Number 410007
🇰🇷Daegu, Korea, Republic of
Investigational Site Number 410002
🇰🇷Seoul, Korea, Republic of
Investigational Site Number 410011
🇰🇷Seoul, Korea, Republic of
Investigational Site Number 410010
🇰🇷Seoul, Korea, Republic of
Investigational Site Number 410008
🇰🇷Seoul, Korea, Republic of
Investigational Site Number 410003
🇰🇷Suwon, Korea, Republic of
Investigational Site Number 428004
🇱🇻Daugavpils, Latvia
Investigational Site Number 428003
🇱🇻Riga, Latvia
Investigational Site Number 484001
🇲🇽Guadalajara, Mexico
Investigational Site Number 440001
🇱🇹Kaunas, Lithuania
Investigational Site Number 428002
🇱🇻Riga, Latvia
Investigational Site Number 440003
🇱🇹Kaunas, Lithuania
Investigational Site Number 484006
🇲🇽Mazatlán, Mexico
Investigational Site Number 554003
🇳🇿Christchurch, New Zealand
Investigational Site Number 554001
🇳🇿Christchurch, New Zealand
Investigational Site Number 554002
🇳🇿Nelson South, New Zealand
Investigational Site Number 578001
🇳🇴Trondheim, Norway
Investigational Site Number 604001
🇵🇪Lima, Peru
Investigational Site Number 604004
🇵🇪Callao, Peru
Investigational Site Number 616001
🇵🇱Bydgoszcz, Poland
Investigational Site Number 604005
🇵🇪Lima, Peru
Investigational Site Number 616006
🇵🇱Gdansk, Poland
Investigational Site Number 616018
🇵🇱Krakow, Poland
Investigational Site Number 616009
🇵🇱Lodz, Poland
Investigational Site Number 616002
🇵🇱Lodz, Poland
Investigational Site Number 616015
🇵🇱Sosnowiec, Poland
Investigational Site Number 616012
🇵🇱Poznan, Poland
Investigational Site Number 616004
🇵🇱Warszawa, Poland
Investigational Site Number 616013
🇵🇱Szczecin, Poland
Investigational Site Number 616007
🇵🇱Wroclaw, Poland
Investigational Site Number 616016
🇵🇱Wroclaw, Poland
Investigational Site Number 643001
🇷🇺Moscow, Russian Federation
Investigational Site Number 643002
🇷🇺Moscow, Russian Federation
Investigational Site Number 643017
🇷🇺St-Petersburg, Russian Federation
Investigational Site Number 752001
🇸🇪Stockholm, Sweden
Investigational Site Number 032012
🇦🇷Rosario, Argentina
Investigational Site Number 076012
🇧🇷Curitiba, Brazil
Investigational Site Number 036008
🇦🇺Redcliffe, Australia
Investigational Site Number 276004
🇩🇪Homburg, Germany
Investigational Site Number 032002
🇦🇷Buenos Aires, Argentina
Investigational Site Number 032005
🇦🇷Santa Fe, Argentina
Investigational Site Number 840020
🇺🇸Teaneck, New Jersey, United States
Investigational Site Number 036001
🇦🇺Kogarah, Australia
Investigational Site Number 276002
🇩🇪Heidelberg, Germany
Investigational Site Number 076010
🇧🇷Belo Horizonte, Brazil
Investigational Site Number 276013
🇩🇪München, Germany
Investigational Site Number 348009
🇭🇺Kistarcsa, Hungary
Investigational Site Number 112005
🇧🇾Minsk, Belarus
Investigational Site Number 203009
🇨🇿Kromeriz, Czech Republic
Investigational Site Number 203004
🇨🇿Liberec, Czech Republic
Investigational Site Number 348004
🇭🇺Szekesfehervar, Hungary
Investigational Site Number 356011
🇮🇳Bangalore, India
Investigational Site Number 604002
🇵🇪Lima, Peru
Investigational Site Number 112003
🇧🇾Minsk, Belarus
Investigational Site Number 112002
🇧🇾Minsk, Belarus
Investigational Site Number 100005
🇧🇬Sofia, Bulgaria
Investigational Site Number 112008
🇧🇾Minsk, Belarus
Investigational Site Number 203016
🇨🇿Ricany, Czech Republic
Investigational Site Number 203010
🇨🇿Usti Nad Labem, Czech Republic
Investigational Site Number 356033
🇮🇳Andhra Pradesh, India
Investigational Site Number 100009
🇧🇬Sofia, Bulgaria
Investigational Site Number 233001
🇪🇪Tartu, Estonia
Investigational Site Number 356005
🇮🇳Ahmedabad, India
Investigational Site Number 356013
🇮🇳Cochin, India
Investigational Site Number 356028
🇮🇳Hyderabad, India
Investigational Site Number 356026
🇮🇳Lucknow, India
Investigational Site Number 440002
🇱🇹Vilnius, Lithuania
Investigational Site Number 604003
🇵🇪Callao, Peru
Investigational Site Number 616020
🇵🇱Krakow, Poland
Investigational Site Number 804005
🇺🇦Kyiv, Ukraine
Investigational Site Number 804008
🇺🇦Odessa, Ukraine
Investigational Site Number 203008
🇨🇿Praha 4, Czech Republic
Investigational Site Number 348003
🇭🇺Szolnok, Hungary
Investigational Site Number 356019
🇮🇳Banglore, India
Investigational Site Number 356025
🇮🇳Gujarat, India
Investigational Site Number 356030
🇮🇳Nagpur, India
Investigational Site Number 616005
🇵🇱Krakow, Poland
Investigational Site Number 616014
🇵🇱Warszawa, Poland
Investigational Site Number 642004
🇷🇴Oradea, Romania
Investigational Site Number 643011
🇷🇺St-Petersburg, Russian Federation
Investigational Site Number 643014
🇷🇺Yaroslavl, Russian Federation
Investigational Site Number 804002
🇺🇦Kyiv, Ukraine
Investigational Site Number 840015
🇺🇸Orlando, Florida, United States
Investigational Site Number 643025
🇷🇺Moscow, Russian Federation
Investigational Site Number 156005
🇨🇳Nanjing, China