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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00697099
Registration number
NCT00697099
Ethics application status
Date submitted
12/06/2008
Date registered
13/06/2008
Date last updated
23/01/2013
Titles & IDs
Public title
Evaluation of AVE5026 as Compared to Enoxaparin for the Prevention of Thromboembolism in Patients Undergoing Total Hip Replacement Surgery
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Scientific title
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 Elective Total Hip Replacement Surgery
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Secondary ID [1]
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2007-007944-80
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Secondary ID [2]
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EFC10342
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Universal Trial Number (UTN)
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Trial acronym
SAVE-HIP1
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Venous Thromboembolism
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Condition category
Condition code
Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Blood
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Clotting disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Semuloparin sodium
Treatment: Drugs - Enoxaparin sodium
Treatment: Drugs - Placebo
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
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
Treatment: Drugs: Semuloparin sodium
0.4 mL (0.2 mL if SRI) solution in ready-to-use 0.5 ml pre-filled syringe
Subcutaneous injection
Treatment: Drugs: Enoxaparin sodium
0.4 mL (0.2 mL if SRI) solution in ready-to-use 0.5 ml pre-filled syringe
Subcutaneous injection
Treatment: Drugs: Placebo
0.4 mL (0.2 mL if SRI) solution in ready-to-use 0.5 ml pre-filled syringe strictly identical in appearance but without active component
Subcutaneous injection
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants Who Experienced Venous Thromboembolism Event [VTE] or Death From Any Cause
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Assessment method [1]
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VTE included 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 included fatal PE and deaths for other reason than PE.
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Timepoint [1]
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From randomization up to 10 days after surgery or the day of mandatory venography, whichever came first
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Secondary outcome [1]
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Percentage of Participants Who Experienced "Major" VTE or All-cause Death
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Assessment method [1]
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"major" VTE included any proximal DVT, symptomatic distal DVT and nonfatal Pulmonary Embolism (PE) as confirmed by the CIAC.
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Timepoint [1]
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From randomization up to 10 days after surgery or the day of mandatory venography, whichever came first
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Secondary outcome [2]
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Percentage of Participants Who Experienced Clinically Relevant Bleedings
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Assessment method [2]
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Bleedings were 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 healthcare professional);
* "Non-clinically relevant bleeding".
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Timepoint [2]
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From first study drug injection up to 3 days after last study drug injection
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Secondary outcome [3]
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Percentage of Participants Who Required the Initiation of Curative Anticoagulant or Thrombolytic Treatment After VTE Assessment
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Assessment method [3]
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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.
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Timepoint [3]
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From randomization up to 10 days after surgery or the day of mandatory venography, whichever came first
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Eligibility
Key inclusion criteria
* Elective total hip replacement surgery or a revision of at least one component of a prosthesis implanted = 6 months prior to study entry.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Any major orthopedic surgery in the 3 months prior to study start;
* Deep vein thrombosis or pulmonary embolism within the last 12 months or known post-phlebitic syndrome;
* High risk of bleeding;
* Known allergy to heparin or enoxaparin;
* Any contra-indications 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.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/06/2008
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/06/2009
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Sample size
Target
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Accrual to date
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Final
2326
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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sanofi-aventis Australia & New Zealand administrative office - Macquarie Park
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Recruitment postcode(s) [1]
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- Macquarie Park
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Recruitment outside Australia
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United States of America
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New Jersey
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Argentina
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Buenos Aires
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Belarus
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Minsk
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Canada
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Laval
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Chile
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Santiago
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Colombia
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Santafe de Bogota
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Praha
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Horsholm
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Estonia
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Tallinn
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Finland
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Helsinki
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Germany
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Berlin
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Greece
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Athens
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India
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Mumbai
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Italy
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Milano
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Mexico
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Mexico
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Norway
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Lysaker
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Peru
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Lima
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Philippines
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Makati City
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Poland
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Warszawa
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Romania
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Bucuresti
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Russian Federation
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Moscow
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Slovakia
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Brastislava
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South Africa
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Midrand
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Spain
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Barcelona
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Sweden
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Bromma
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Taipei
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Bangkok
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Turkey
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Istanbul
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Ukraine
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Kiev
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Sanofi
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Address
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Ethics approval
Ethics application status
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Summary
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 prevention of Venous Thromboembolic Events \[VTE\] in patients undergoing elective total hip replacement surgery. The secondary objectives were to evaluate the safety of AVE5026 in patients undergoing elective total hip replacement surgery, and to document AVE5026 exposure in this population.
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Trial website
https://clinicaltrials.gov/study/NCT00697099
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Trial related presentations / publications
Lassen MR, Fisher W, Mouret P, Agnelli G, George D, Kakkar A, Mismetti P, Turpie AG; SAVE Investigators. Semuloparin for prevention of venous thromboembolism after major orthopedic surgery: results from three randomized clinical trials, SAVE-HIP1, SAVE-HIP2 and SAVE-KNEE. J Thromb Haemost. 2012 May;10(5):822-32. doi: 10.1111/j.1538-7836.2012.04701.x.
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Public notes
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Contacts
Principal investigator
Name
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Patrick MOURET, MD
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Address
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Orthopädische Klinik, Stätische Klinik, Gotenstrasse 6-8, Frankfurt Höechst, 65929 Frankfurt, Germany
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Type
Citations or Other Details
Journal
Lassen MR, Fisher W, Mouret P, Agnelli G, George D...
[
More Details
]
Results not provided in
https://clinicaltrials.gov/study/NCT00697099
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