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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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
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
Secondary ID [1] 0 0
2007-007944-80
Secondary ID [2] 0 0
EFC10342
Universal Trial Number (UTN)
Trial acronym
SAVE-HIP1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Venous Thromboembolism 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Blood 0 0 0 0
Clotting disorders

Intervention/exposure
Study type
Interventional
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

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Who Experienced Venous Thromboembolism Event [VTE] or Death From Any Cause - 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.
Timepoint [1] 0 0
From randomization up to 10 days after surgery or the day of mandatory venography, whichever came first
Secondary outcome [1] 0 0
Percentage of Participants Who Experienced "Major" VTE or All-cause Death - "major" VTE included any proximal DVT, symptomatic distal DVT and nonfatal Pulmonary Embolism (PE) as confirmed by the CIAC.
Timepoint [1] 0 0
From randomization up to 10 days after surgery or the day of mandatory venography, whichever came first
Secondary outcome [2] 0 0
Percentage of Participants Who Experienced Clinically Relevant Bleedings - 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".
Timepoint [2] 0 0
From first study drug injection up to 3 days after last study drug injection
Secondary outcome [3] 0 0
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 venography.
Timepoint [3] 0 0
From randomization up to 10 days after surgery or the day of mandatory venography, whichever came first

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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
sanofi-aventis Australia & New Zealand administrative office - Macquarie Park
Recruitment postcode(s) [1] 0 0
- Macquarie Park
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
New Jersey
Country [2] 0 0
Argentina
State/province [2] 0 0
Buenos Aires
Country [3] 0 0
Belarus
State/province [3] 0 0
Minsk
Country [4] 0 0
Canada
State/province [4] 0 0
Laval
Country [5] 0 0
Chile
State/province [5] 0 0
Santiago
Country [6] 0 0
Colombia
State/province [6] 0 0
Santafe de Bogota
Country [7] 0 0
Czech Republic
State/province [7] 0 0
Praha
Country [8] 0 0
Denmark
State/province [8] 0 0
Horsholm
Country [9] 0 0
Estonia
State/province [9] 0 0
Tallinn
Country [10] 0 0
Finland
State/province [10] 0 0
Helsinki
Country [11] 0 0
Germany
State/province [11] 0 0
Berlin
Country [12] 0 0
Greece
State/province [12] 0 0
Athens
Country [13] 0 0
India
State/province [13] 0 0
Mumbai
Country [14] 0 0
Italy
State/province [14] 0 0
Milano
Country [15] 0 0
Mexico
State/province [15] 0 0
Mexico
Country [16] 0 0
Norway
State/province [16] 0 0
Lysaker
Country [17] 0 0
Peru
State/province [17] 0 0
Lima
Country [18] 0 0
Philippines
State/province [18] 0 0
Makati City
Country [19] 0 0
Poland
State/province [19] 0 0
Warszawa
Country [20] 0 0
Romania
State/province [20] 0 0
Bucuresti
Country [21] 0 0
Russian Federation
State/province [21] 0 0
Moscow
Country [22] 0 0
Slovakia
State/province [22] 0 0
Brastislava
Country [23] 0 0
South Africa
State/province [23] 0 0
Midrand
Country [24] 0 0
Spain
State/province [24] 0 0
Barcelona
Country [25] 0 0
Sweden
State/province [25] 0 0
Bromma
Country [26] 0 0
Taiwan
State/province [26] 0 0
Taipei
Country [27] 0 0
Thailand
State/province [27] 0 0
Bangkok
Country [28] 0 0
Turkey
State/province [28] 0 0
Istanbul
Country [29] 0 0
Ukraine
State/province [29] 0 0
Kiev

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Sanofi
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT00697099
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Patrick MOURET, MD
Address 0 0
Orthopädische Klinik, Stätische Klinik, Gotenstrasse 6-8, Frankfurt Höechst, 65929 Frankfurt, Germany
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications