Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00718224




Registration number
NCT00718224
Ethics application status
Date submitted
17/07/2008
Date registered
18/07/2008
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 Elective Knee Replacement Surgery
Scientific title
A Multinational, Multicenter, Randomized, Double-blind Study Comparing the Efficacy and Safety of Semuloparin (AVE5026) With Enoxaparin for the Prevention of Venous Thromboembolism in Patients Undergoing Elective Knee Replacement Surgery
Secondary ID [1] 0 0
2007-007946-37
Secondary ID [2] 0 0
EFC10571
Universal Trial Number (UTN)
Trial acronym
SAVE-KNEE
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
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

To maintain the blind, placebo for Enoxaparin sodium:

* 12 and 24 hours after surgery, then once daily if no SRI
* 12 hours after surgery only if SRI

Active comparator: Enoxaparin - Enoxaparin sodium 30 mg twice daily (20 mg once daily if Severe Renal Impairment \[SRI\]) for 7-10 days with an initial dose given 12 hours after surgery

Placebo for Semuloparin sodium 8 hours after surgery to maintain the blind


Treatment: Drugs: Semuloparin sodium
0.3 mL (0.2 mL if SRI) solution in ready-to-use 0.5 mL pre-filled syringe

Subcutaneous injection

Treatment: Drugs: Enoxaparin
0.3 mL (0.2 mL if SRI) solution in ready-to-use 0.5 mL pre-filled syringe

Subcutaneous injection

Treatment: Drugs: Placebo
0.3 mL (0.2 mL if SRI) solution in ready-to-use 0.5 ml prefilled 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 All-cause Death
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
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
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
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
- Knee replacement surgery or revision of at least one component of a knee prosthesis implanted = 6 months prior to study entry.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Any major orthopedic surgeries in the 3 months prior to study;
* Deep vein thrombosis or pulmonary embolism within the last 12 months, or known post-phlebitic syndrome;
* Any contraindications to the performance of venography;
* High risk of bleeding;
* Know allergy to heparin, or enoxaparin, or pork products;
* 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
1/07/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2009
Sample size
Target
Accrual to date
Final
1150
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
Colombia
State/province [5] 0 0
Santafe de Bogota
Country [6] 0 0
Czech Republic
State/province [6] 0 0
Praha
Country [7] 0 0
Denmark
State/province [7] 0 0
Horsholm
Country [8] 0 0
Estonia
State/province [8] 0 0
Tallinn
Country [9] 0 0
Greece
State/province [9] 0 0
Athens
Country [10] 0 0
Lithuania
State/province [10] 0 0
Vilnius
Country [11] 0 0
Mexico
State/province [11] 0 0
Mexico
Country [12] 0 0
Poland
State/province [12] 0 0
Warszawa
Country [13] 0 0
Romania
State/province [13] 0 0
Bucuresti
Country [14] 0 0
Russian Federation
State/province [14] 0 0
Moscow
Country [15] 0 0
South Africa
State/province [15] 0 0
Midrand
Country [16] 0 0
Ukraine
State/province [16] 0 0
Kiev

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Michael R. LASSEN, MD
Address 0 0
Horsholm Hospital, Horsholm, Denmark
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

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

TypeCitations or Other Details
Journal Lassen MR, Fisher W, Mouret P, Agnelli G, George D... [More Details]

Results not provided in https://clinicaltrials.gov/study/NCT00718224