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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00679588




Registration number
NCT00679588
Ethics application status
Date submitted
7/05/2008
Date registered
19/05/2008
Date last updated
16/12/2013

Titles & IDs
Public title
Evaluation of AVE5026 as Compared to Enoxaparin for the Prevention of Venous Thromboembolism in Patients Undergoing Major Abdominal 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 Major Abdominal Surgery
Secondary ID [1] 0 0
2007-007942-36
Secondary ID [2] 0 0
EFC6520
Universal Trial Number (UTN)
Trial acronym
SAVE-ABDO
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 prefilled syringe strictly identical in appearance containing the same volume 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 Experience 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 comes first
Secondary outcome [1] 0 0
Percentage of Participants Who Experience "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 comes first
Secondary outcome [2] 0 0
Percentage of Participants Who Experience Clinically Relevant Bleedings ("major" and "clinically relevant non-major" bleedings )
Timepoint [2] 0 0
From 1st study drug injection up to 3 days after last study drug injection
Secondary outcome [3] 0 0
Percentage of Participants requiring 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 comes first

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 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
1/04/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2010
Sample size
Target
Accrual to date
Final
4413
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Investigational Site Number 036002 - Box Hill
Recruitment hospital [2] 0 0
Investigational Site Number 036003 - Box Hill
Recruitment hospital [3] 0 0
Investigational Site Number 036001 - Kogarah
Recruitment hospital [4] 0 0
Investigational Site Number 036008 - Redcliffe
Recruitment postcode(s) [1] 0 0
3128 - Box Hill
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment postcode(s) [3] 0 0
4020 - Redcliffe
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United States of America
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Sanofi
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00679588
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ajay Kakkar, Prof., MD, PhD
Address 0 0
Queen Mary's School of Medicine & Dentistry, London (UK)
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