Evaluation of AVE5026 as Compared to Enoxaparin for the Prevention of Venous Thromboembolism in Patients Undergoing Major Abdominal Surgery (SAVE-ABDO)

November 21, 2013 updated by: Sanofi

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 Major Abdominal Surgery

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

4413

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1155
        • Investigational Site Number 032002
      • Buenos Aires, Argentina, 1416
        • Investigational Site Number 032001
      • Buenos Aires, Argentina
        • Investigational Site Number 032004
      • Capital Federal, Argentina, 1039
        • Investigational Site Number 032007
      • Capital Federal, Argentina, C1408INH
        • Investigational Site Number 032008
      • Córdoba, Argentina, X5000AAI
        • Investigational Site Number 032014
      • Rosario, Argentina, 2000
        • Investigational Site Number 032012
      • Santa Fe, Argentina, S3000EPV
        • Investigational Site Number 032005
  • Australia
      • Box Hill, Australia, 3128
        • Investigational Site Number 036002
      • Box Hill, Australia, 3128
        • Investigational Site Number 036003
      • Kogarah, Australia, 2217
        • Investigational Site Number 036001
      • Redcliffe, Australia, 4020
        • Investigational Site Number 036008
  • Austria
      • Graz, Austria, 8036
        • Investigational Site Number 040001
      • Wels, Austria, 4600
        • Investigational Site Number 040002
  • Belarus
      • Gomel, Belarus, 246012
        • Investigational Site Number 112001
      • Gomel, Belarus, 246012
        • Investigational Site Number 112006
      • Minsk, Belarus, 220013
        • Investigational Site Number 112003
      • Minsk, Belarus, 223040
        • Investigational Site Number 112008
      • Minsk, Belarus
        • Investigational Site Number 112002
      • Minsk, Belarus
        • Investigational Site Number 112005
      • Vitebsk, Belarus, 210603
        • Investigational Site Number 112004
      • Vitebsk, Belarus
        • Investigational Site Number 112007
  • Belgium
      • Genk, Belgium, 3600
        • Investigational Site Number 056002
      • Gent, Belgium, 9000
        • Investigational Site Number 056001
  • Brazil
      • Belo Horizonte, Brazil, 30150-221
        • Investigational Site Number 076003
      • Belo Horizonte, Brazil, 30380-490
        • Investigational Site Number 076010
      • Caxias Do Sul, Brazil, 95001-960
        • Investigational Site Number 076014
      • Curitiba, Brazil, 80050-350
        • Investigational Site Number 076012
      • Curitiba, Brazil, 81520-060
        • Investigational Site Number 076005
      • Goiania, Brazil, 74605-070
        • Investigational Site Number 076006
      • Joinville, Brazil, 89202-000
        • Investigational Site Number 076011
      • Porto Alegre, Brazil, 90035 003
        • Investigational Site Number 076007
      • Porto Alegre, Brazil, 90610-000
        • Investigational Site Number 076009
      • Ribeirao Preto, Brazil, 14049-900
        • Investigational Site Number 076015
      • Sao Jose Do Rio Preto, Brazil, 15090-000
        • Investigational Site Number 076013
      • Sao Paulo, Brazil, 01323-001
        • Investigational Site Number 076004
      • Sao Paulo, Brazil, 05403-000
        • Investigational Site Number 076002
      • Sao Paulo, Brazil, 08270-070
        • Investigational Site Number 076008
  • Bulgaria
      • Pleven, Bulgaria, 5800
        • Investigational Site Number 100004
      • Ruse, Bulgaria, 7002
        • Investigational Site Number 100003
      • Sofia, Bulgaria, 1407
        • Investigational Site Number 100011
      • Sofia, Bulgaria, 1606
        • Investigational Site Number 100005
      • Sofia, Bulgaria, 1606
        • Investigational Site Number 100008
      • Sofia, Bulgaria, 1606
        • Investigational Site Number 100009
      • Varna, Bulgaria, 9010
        • Investigational Site Number 100006
      • Varna, Bulgaria, 9010
        • Investigational Site Number 100010
  • Canada
      • Edmonton, Canada, T6G 2B7
        • Investigational Site Number 124001
      • Kitchener, Canada, N2G 1G3
        • Investigational Site Number 124004
      • Montreal, Canada, H3G 1A4
        • Investigational Site Number 124010
      • Red Deer, Canada, T4N 4E6
        • Investigational Site Number 124011
      • Saint John, Canada, E2L 4L2
        • Investigational Site Number 124009
      • Thunder Bay, Canada, P7B 6V1
        • Investigational Site Number 124002
      • Vancouver, Canada, V5Z 4E3
        • Investigational Site Number 124007
  • Chile
      • Rancagua, Chile
        • Investigational Site Number 152002
      • Santiago, Chile, 838-0456
        • Investigational Site Number 152001
  • China
      • Baotou, China, 014010
        • Investigational Site Number 156011
      • Changsha, China, 410008
        • Investigational Site Number 156012
      • Changsha, China, 410013
        • Investigational Site Number 156010
      • Fuzhou, China, 354200
        • Investigational Site Number 156006
      • Guangzhou, China, 510060
        • Investigational Site Number 156003
      • Haikou, China, 570208
        • Investigational Site Number 156013
      • Nanjing, China, 210006
        • Investigational Site Number 156005
      • Qingdao, China, 266003
        • Investigational Site Number 156008
      • Shijiazhuang, China, 050051
        • Investigational Site Number 156001
      • Tianjin, China, 300121
        • Investigational Site Number 156014
      • Xi'An, China, 710038
        • Investigational Site Number 156004
  • Croatia
      • Pozega, Croatia, 34000
        • Investigational Site Number 191004
      • Pula, Croatia, 52100
        • Investigational Site Number 191001
      • Zagreb, Croatia, 10000
        • Investigational Site Number 191002
  • Czech Republic
      • Brno, Czech Republic, 62500
        • Investigational Site Number 203007
      • Brno, Czech Republic, 65691
        • Investigational Site Number 203001
      • Jihlava, Czech Republic, 58633
        • Investigational Site Number 203011
      • Kolin, Czech Republic, 28020
        • Investigational Site Number 203015
      • Kromeriz, Czech Republic, 76755
        • Investigational Site Number 203009
      • Liberec, Czech Republic, 46063
        • Investigational Site Number 203004
      • Most, Czech Republic, 43464
        • Investigational Site Number 203014
      • Ostrava, Czech Republic, 72880
        • Investigational Site Number 203003
      • Pardubice, Czech Republic, 53203
        • Investigational Site Number 203012
      • Praha 4, Czech Republic, 14059
        • Investigational Site Number 203008
      • Praha 5, Czech Republic, 15006
        • Investigational Site Number 203006
      • Praha 6, Czech Republic, 16902
        • Investigational Site Number 203002
      • Ricany, Czech Republic, 25001
        • Investigational Site Number 203016
      • Usti Nad Labem, Czech Republic, 40113
        • Investigational Site Number 203010
  • Denmark
      • København Nv, Denmark, 2400
        • Investigational Site Number 208001
      • Odense C, Denmark, 5000
        • Investigational Site Number 208002
  • Estonia
      • Tallinn, Estonia, 13419
        • Investigational Site Number 233003
      • Tartu, Estonia, 50406
        • Investigational Site Number 233001
      • Tartu, Estonia, 50406
        • Investigational Site Number 233002
  • Germany
      • Bochum, Germany, 44791
        • Investigational Site Number 276011
      • Castrop-Rauxel, Germany, 44575
        • Investigational Site Number 276015
      • Castrop-Rauxel, Germany, 44575
        • Investigational Site Number 276018
      • Dresden, Germany, 01067
        • Investigational Site Number 276006
      • Hannover, Germany, 30625
        • Investigational Site Number 276012
      • Heidelberg, Germany, 69120
        • Investigational Site Number 276002
      • Homburg, Germany, 66421
        • Investigational Site Number 276004
      • Lübeck, Germany, 23538
        • Investigational Site Number 276014
      • Magdeburg, Germany, 39130
        • Investigational Site Number 276016
      • München, Germany, 81675
        • Investigational Site Number 276013
      • Stralsund, Germany, 18435
        • Investigational Site Number 276001
  • Greece
      • Heraklion, Greece, 71110
        • Investigational Site Number 300002
  • Hungary
      • Debrecen, Hungary, 4032
        • Investigational Site Number 348007
      • Kistarcsa, Hungary, 2143
        • Investigational Site Number 348009
      • Szeged, Hungary, 6720
        • Investigational Site Number 348008
      • Szekesfehervar, Hungary, 8000
        • Investigational Site Number 348004
      • Szolnok, Hungary, 5000
        • Investigational Site Number 348003
  • India
      • Ahmedabad, India, 380 006
        • Investigational Site Number 356005
      • Ahmedabad, India, 380 008
        • Investigational Site Number 356004
      • Andhra Pradesh, India
        • Investigational Site Number 356033
      • Bangalore, India
        • Investigational Site Number 356008
      • Bangalore, India, 560 034
        • Investigational Site Number 356011
      • Bangalore, India, 560029
        • Investigational Site Number 356027
      • Banglore, India, 560054
        • Investigational Site Number 356019
      • Bhopal, India
        • Investigational Site Number 356031
      • Chennai, India, 600 096
        • Investigational Site Number 356014
      • Chennai, India, 600010
        • Investigational Site Number 356018
      • Chennai, India, 600035
        • Investigational Site Number 356016
      • Chennai, India, 600101
        • Investigational Site Number 356021
      • Cochin, India, 682026
        • Investigational Site Number 356013
      • Coimbatore, India, 641037
        • Investigational Site Number 356006
      • Gujarat, India, 380006
        • Investigational Site Number 356025
      • Hyderabad, India, 500004
        • Investigational Site Number 356028
      • Hyderabad, India, 500082
        • Investigational Site Number 356010
      • Jaipur, India, 302013
        • Investigational Site Number 356002
      • Jaipur, India
        • Investigational Site Number 356022
      • Kochi, India, 682304
        • Investigational Site Number 356007
      • Lucknow, India
        • Investigational Site Number 356026
      • Ludhiana, India, 141001
        • Investigational Site Number 356032
      • Luknow, India, 226014
        • Investigational Site Number 356003
      • Mangalore, India
        • Investigational Site Number 356001
      • Nagpur, India
        • Investigational Site Number 356030
      • New Delhi, India, 110085
        • Investigational Site Number 356009
      • Pune, India, 411 011
        • Investigational Site Number 356023
      • Pune, India, 411001
        • Investigational Site Number 356015
      • Punjgutta, India
        • Investigational Site Number 356012
  • Italy
      • Aviano, Italy, 33081
        • Investigational Site Number 380009
      • Genova, Italy, 16132
        • Investigational Site Number 380001
      • Genova, Italy, 16132
        • Investigational Site Number 380015
      • Milano, Italy, 20132
        • Investigational Site Number 380006
      • Padova, Italy, 35128
        • Investigational Site Number 380004
      • Parma, Italy, 43100
        • Investigational Site Number 380008
      • Piacenza, Italy, 29100
        • Investigational Site Number 380013
      • Pordenone, Italy, 33170
        • Investigational Site Number 380012
      • Reggio Emilia, Italy, 42100
        • Investigational Site Number 380005
      • San Donato Milanese, Italy, 20097
        • Investigational Site Number 380011
      • Trieste, Italy, 34149
        • Investigational Site Number 380007
  • Korea, Republic of
      • Daegu, Korea, Republic of, 700-712
        • Investigational Site Number 410007
      • Goyang, Korea, Republic of, 410-773
        • Investigational Site Number 410006
      • Gyeonggi-do, Korea, Republic of, 420-767
        • Investigational Site Number 410001
      • Incheon, Korea, Republic of, 400-711
        • Investigational Site Number 410009
      • Seoul, Korea, Republic of, 135-710
        • Investigational Site Number 410002
      • Seoul, Korea, Republic of, 120-752
        • Investigational Site Number 410004
      • Seoul, Korea, Republic of, 110-744
        • Investigational Site Number 410011
      • Seoul, Korea, Republic of, 135-720
        • Investigational Site Number 410010
      • Seoul, Korea, Republic of, 138-878
        • Investigational Site Number 410008
      • Suwon, Korea, Republic of, 443-721
        • Investigational Site Number 410003
  • Latvia
      • Daugavpils, Latvia, LV-5417
        • Investigational Site Number 428004
      • Riga, Latvia, LV-1002
        • Investigational Site Number 428003
      • Riga, Latvia, LV-1038
        • Investigational Site Number 428002
  • Lithuania
      • Kaunas, Lithuania, LT-50009
        • Investigational Site Number 440001
      • Kaunas, Lithuania, LT-47144
        • Investigational Site Number 440003
      • Vilnius, Lithuania, LT-10207
        • Investigational Site Number 440002
  • Mexico
      • Guadalajara, Mexico, 44340
        • Investigational Site Number 484001
      • Mazatlán, Mexico, 82110
        • Investigational Site Number 484006
  • New Zealand
      • Christchurch, New Zealand, 8011
        • Investigational Site Number 554003
      • Christchurch, New Zealand, 8014
        • Investigational Site Number 554001
      • Nelson South, New Zealand, 7010
        • Investigational Site Number 554002
  • Norway
      • Trondheim, Norway, 7006
        • Investigational Site Number 578001
  • Peru
      • Callao, Peru, Callao 02
        • Investigational Site Number 604003
      • Callao, Peru
        • Investigational Site Number 604004
      • Lima, Peru, LIMA 11
        • Investigational Site Number 604006
      • Lima, Peru, LIMA 13
        • Investigational Site Number 604001
      • Lima, Peru, LIMA 18
        • Investigational Site Number 604005
      • Lima, Peru, Lima 29
        • Investigational Site Number 604002
  • Poland
      • Bydgoszcz, Poland, 85-094
        • Investigational Site Number 616001
      • Bydgoszcz, Poland, 85-168
        • Investigational Site Number 616003
      • Gdansk, Poland
        • Investigational Site Number 616006
      • Krakow, Poland, 31-501
        • Investigational Site Number 616005
      • Krakow, Poland, 31-826
        • Investigational Site Number 616018
      • Krakow, Poland, 31-913
        • Investigational Site Number 616020
      • Lodz, Poland, 90-153
        • Investigational Site Number 616009
      • Lodz, Poland, 90-647
        • Investigational Site Number 616002
      • Lublin, Poland, 20-081
        • Investigational Site Number 616010
      • Poznan, Poland, 60-747
        • Investigational Site Number 616012
      • Sosnowiec, Poland, 41-200
        • Investigational Site Number 616015
      • Szczecin, Poland, 70-111
        • Investigational Site Number 616013
      • Torun, Poland, 87-100
        • Investigational Site Number 616011
      • Warszawa, Poland, 02-097
        • Investigational Site Number 616004
      • Warszawa, Poland, 03-242
        • Investigational Site Number 616014
      • Wroclaw, Poland, 50 -556
        • Investigational Site Number 616008
      • Wroclaw, Poland, 50-326
        • Investigational Site Number 616007
      • Wroclaw, Poland, 51-124
        • Investigational Site Number 616016
  • Romania
      • Cluj-Napoca, Romania, 400015
        • Investigational Site Number 642006
      • Cluj-Napoca, Romania, 400006
        • Investigational Site Number 642003
      • Cluj-Napoca, Romania, 400132
        • Investigational Site Number 642005
      • Oradea, Romania, 410169
        • Investigational Site Number 642001
      • Oradea, Romania, 410169
        • Investigational Site Number 642004
      • Timisoara, Romania, 300736
        • Investigational Site Number 642002
  • Russian Federation
      • Krasnodar, Russian Federation, 350086
        • Investigational Site Number 643019
      • Krasnoyarsk, Russian Federation, 660058
        • Investigational Site Number 643006
      • Moscow, Russian Federation, 105229
        • Investigational Site Number 643003
      • Moscow, Russian Federation, 115280
        • Investigational Site Number 643001
      • Moscow, Russian Federation, 119048
        • Investigational Site Number 643002
      • Moscow, Russian Federation, 119415
        • Investigational Site Number 643020
      • Moscow, Russian Federation, 119991
        • Investigational Site Number 643021
      • Moscow, Russian Federation, 125367
        • Investigational Site Number 643025
      • Novosibirsk, Russian Federation, 630047
        • Investigational Site Number 643008
      • Novosibirsk, Russian Federation, 630054
        • Investigational Site Number 643007
      • Omsk, Russian Federation, 644013
        • Investigational Site Number 643026
      • Sestroretsk,, Russian Federation, 197706
        • Investigational Site Number 643015
      • St-Petersburg, Russian Federation, 191104
        • Investigational Site Number 643011
      • St-Petersburg, Russian Federation, 195067
        • Investigational Site Number 643018
      • St-Petersburg, Russian Federation, 199004
        • Investigational Site Number 643017
      • St. Petersburg, Russian Federation, 194291
        • Investigational Site Number 643010
      • St.-Petersburg, Russian Federation, 194354
        • Investigational Site Number 643009
      • Tomsk, Russian Federation, 634063
        • Investigational Site Number 643012
      • Vsevolozhsk, Russian Federation, 188640
        • Investigational Site Number 643016
      • Yaroslavl, Russian Federation, 150062
        • Investigational Site Number 643014
  • Serbia
      • Belgrade, Serbia, 11080
        • Investigational Site Number 688004
      • Belgrade, Serbia, 11080
        • Investigational Site Number 688001
      • Novi Sad, Serbia, 21000
        • Investigational Site Number 688002
  • Slovakia
      • Bratislava, Slovakia, 821 01
        • Investigational Site Number 703001
  • Slovenia
      • Celje, Slovenia, 3000
        • Investigational Site Number 705001
      • Maribor, Slovenia, 2000
        • Investigational Site Number 705002
  • South Africa
      • Cape Town, South Africa, 7130
        • Investigational Site Number 710001
      • Cape Town, South Africa
        • Investigational Site Number 710004
      • Worcester, South Africa, 6850
        • Investigational Site Number 710003
  • Spain
      • Barcelona, Spain, 08907
        • Investigational Site Number 724001
      • Madrid, Spain, 28007
        • Investigational Site Number 724002
  • Sweden
      • Kungälv, Sweden, 442 83
        • Investigational Site Number 752002
      • Norrköping, Sweden, 601 82
        • Investigational Site Number 752004
      • Stockholm, Sweden, 14186
        • Investigational Site Number 752001
      • Varberg, Sweden, 432 81
        • Investigational Site Number 752003
  • Turkey
      • Istanbul, Turkey, 34147
        • Investigational Site Number 792003
      • Istanbul, Turkey, 34390
        • Investigational Site Number 792001
      • Istanbul, Turkey
        • Investigational Site Number 792006
      • Izmir, Turkey, 35360
        • Investigational Site Number 792007
  • Ukraine
      • Cherkasy, Ukraine, 18009
        • Investigational Site Number 804003
      • Donetsk, Ukraine, 83092
        • Investigational Site Number 804010
      • Donetsk, Ukraine, 83092
        • Investigational Site Number 804007
      • Kharkiv, Ukraine, 61037
        • Investigational Site Number 804011
      • Kyiv, Ukraine, 3022
        • Investigational Site Number 804005
      • Kyiv, Ukraine
        • Investigational Site Number 804002
      • Kyiv, Ukraine
        • Investigational Site Number 804004
      • Odessa, Ukraine, 65025
        • Investigational Site Number 804008
  • United Kingdom
      • London, United Kingdom, SE5 9PJ
        • Investigational Site Number 826001
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • Investigational Site Number 840026
      • Birmingham, Alabama, United States, 35209
        • Investigational Site Number 840035
      • Birmingham, Alabama, United States, 35209
        • Investigational Site Number 840042
      • Birmingham, Alabama, United States, 35234
        • Investigational Site Number 840002
    • California
      • Corlton, California, United States, 82324
        • Investigational Site Number 840031
      • Huntingdon Beach, California, United States, 92647
        • Investigational Site Number 840007
      • Los Angeles, California, United States, 90033
        • Investigational Site Number 840014
      • Sant Barbara, California, United States, 93105
        • Investigational Site Number 840011
    • Colorado
      • Denver, Colorado, United States, 80262
        • Investigational Site Number 840021
    • Florida
      • Clearwater, Florida, United States, 33756
        • Investigational Site Number 840029
      • Jacksonville, Florida, United States, 32209
        • Investigational Site Number 840017
      • Miami, Florida, United States, 33136
        • Investigational Site Number 840044
      • Orlando, Florida, United States, 32804
        • Investigational Site Number 840015
    • Georgia
      • Columbus, Georgia, United States, 31904
        • Investigational Site Number 840009
    • Illinois
      • Maywood, Illinois, United States, 60153
        • Investigational Site Number 840019
      • Springfield, Illinois, United States, 62702
        • Investigational Site Number 840036
    • Kentucky
      • Hazard, Kentucky, United States, 41701
        • Investigational Site Number 840037
    • Missouri
      • St Louis, Missouri, United States, 63104
        • Investigational Site Number 840008
    • New Jersey
      • Teaneck, New Jersey, United States, 07666
        • Investigational Site Number 840020
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Investigational Site Number 840051
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15240
        • Investigational Site Number 840006
    • Texas
      • Houston, Texas, United States, 77024
        • Investigational Site Number 840025
      • Houston, Texas, United States, 77070
        • Investigational Site Number 840050
      • Lubbock, Texas, United States, 79409
        • Investigational Site Number 840032
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • Investigational Site Number 840043

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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)
Drug: Semuloparin Sodium

0.4 mL (0.2 mL if SRI) solution in ready-to-use 0.5 ml pre-filled syringe

Subcutaneous injection

Other Names:
  • AVE5026
Drug: Placebo

0.4 mL (0.2 mL if SRI) solution in ready-to-use 0.5 ml prefilled syringe strictly identical in appearance containing the same volume but without active component

Subcutaneous injection
Active Comparator: 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)
Drug: Enoxaparin sodium

0.4 mL (0.2 mL if SRI) solution in ready-to-use 0.5 ml pre-filled syringe

Subcutaneous injection

Other Names:
  • Lovenox®
Drug: Placebo

0.4 mL (0.2 mL if SRI) solution in ready-to-use 0.5 ml prefilled syringe strictly identical in appearance containing the same volume but without active component

Subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Who Experience 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 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.
From randomization up to 10 days after surgery or the day of mandatory venography, whichever comes first

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Who Experience "major" VTE or All-cause Death
Time Frame: 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.
From randomization up to 10 days after surgery or the day of mandatory venography, whichever comes first
Percentage of Participants Who Experience Clinically Relevant Bleedings ("major" and "clinically relevant non-major" bleedings )
Time Frame: 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".
From 1st study drug injection up to 3 days after last study drug injection
Percentage of Participants requiring the initiation of curative anticoagulant or thrombolytic treatment after VTE assessment
Time Frame: 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.
From randomization up to 10 days after surgery or the day of mandatory venography, whichever comes first

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Deaths on Treatment
Time Frame: From 1st study drug injection up to 3 days after last study drug injection
All deaths are centrally and blindly reviewed by the CIAC and classified as fatal PE, fatal bleeding, cardiovascular death or other based on relevant documentation (e.g. autopsy report).
From 1st study drug injection up to 3 days after last study drug injection
Platelets Count: Percentage of Participants With Potentially Clinically Significant Abnormalities (PCSA)
Time Frame: From 1st study drug injection up to 3 days after last study drug injection

PCSA are abnormal values considered medically important by the Sponsor according to predefined criteria based on literature review.

Thresholds for platelet counts are defined as <100 Giga/L.
From 1st study drug injection up to 3 days after last study drug injection
Liver Function: Percentage of Participants With Potentially Clinically Significant Abnormalities (PCSA)
Time Frame: From 1st study drug injection up to 3 days after last study drug injection

Thresholds are defined as follows:

  • Alanine Aminotransferase (ALT) >3 Upper Normal Limit (ULN);
  • Total Bilirubin (TB) >2 ULN;
  • ALT >3 ULN and TB >2 ULN;

Cases with ALT >3 ULN and TB >2 ULN (not necessarily concomitant) are evaluated by a blinded independent adjudicator to determine if they met Hy's law criteria.
From 1st study drug injection up to 3 days after last study drug injection
Trough Plasma Concentration of Semuloparin Sodium (AVE5026)
Time Frame: 0.5-1 and 2-4 hours after Day 1 first post-operative injection, 6-8 and 10-16 hours after Day 4 injection, and just before the last injection

Trough Plasma Concentration [Ctrough] is defined as plasma concentrations obtained just before study drug injection (i.e.24h±2h after study drug injection).

Lower Limit Of Quantification (LLOQ) is defined as 0,348 μgEq/mL. Concentrations below LLOQ are replaced by half of LLOQ for the calculation.
0.5-1 and 2-4 hours after Day 1 first post-operative injection, 6-8 and 10-16 hours after Day 4 injection, and just before the last injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Investigators

  • Principal Investigator: Ajay Kakkar, Prof., MD, PhD, Queen Mary's School of Medicine & Dentistry, London (UK)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

May 7, 2008

First Submitted That Met QC Criteria

May 16, 2008

First Posted (Estimate)

May 19, 2008

Study Record Updates

Last Update Posted (Estimate)

December 16, 2013

Last Update Submitted That Met QC Criteria

November 21, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EFC6520
  • 2007-007942-36 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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