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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00714597




Registration number
NCT00714597
Ethics application status
Date submitted
9/07/2008
Date registered
14/07/2008
Date last updated
23/01/2013

Titles & IDs
Public title
Evaluation of AVE5026 in the Prevention of Venous Thromboembolism in Acutely Ill Medical Patients With Restricted Mobility
Scientific title
A Multinational, Multicenter, Randomized, Double-Blind Study Comparing the Efficacy and Safety of AVE5026 With Enoxaparin for the Primary Prevention of Venous Thromboembolism in Acutely Ill Medical Patients With Restricted Mobility
Secondary ID [1] 0 0
2008-000228-13
Secondary ID [2] 0 0
EFC10572
Universal Trial Number (UTN)
Trial acronym
SAVE-VEMED
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

Experimental: Semuloparin - Semuloparin sodium 20 mg (10 mg if Severe Renal Impairment [SRI]) once daily for 10-14 days

Active Comparator: Enoxaparin - Enoxaparin sodium 40 mg (20 mg if Severe Renal Impairment [SRI]) once daily for 10-14 days


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

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 VTE-related Death - VTE included:
asymptomatic proximal Deep Vein Thrombosis (DVT) detected by the mandatory CUS and confirmed by a Compression Ultrasound Adjudication Committee (CUSAC) after central and blind review of the mandatory CUS;
symptomatic DVT and non-fatal Pulmonary Embolism (PE) reported by the investigator and confirmed by a Central Independent Adjudication Committee (CIAC) after central and blind review of diagnosis tests.
VTE-related Death included fatal PE and unexplained deaths.
Timepoint [1] 0 0
From randomization up to 15 days after randomization or the day of the mandatory Compression Ultrasound (CUS), whichever came first
Secondary outcome [1] 0 0
Percentage of Participants Who Experienced asymptomatic proximal DVT
Timepoint [1] 0 0
From randomization up to 15 days after randomization or the day of the mandatory CUS, 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, symptomatic in a critical area/organ, causing a post-operative drop in hemoglobin =2 g/dL or requiring post-operative transfusion =2 units of blood);
"clinically relevant non-major" (overt bleeding requiring medical intervention and not meeting criteria for major bleeding);
"Non-clinically relevant bleeding".
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 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 CUS.
Timepoint [3] 0 0
From randomization up to 15 days after randomization or the day of mandatory CUS, whichever came first

Eligibility
Key inclusion criteria
Patient with an acute medical condition requiring bed rest for at least 3 days, and
hospitalized for at least one of the following medical conditions:

- Congestive heart failure (New York Heart Association [NYHA] class III/IV);

- Acute respiratory failure (not requiring mechanical ventilation);

- Acute infection (without septic shock)*;

- Acute rheumatic disorder*;

- Acute episode of inflammatory bowel disease*.

- Patient with one of these conditions should have at least one additional risk
factor for venous thromboembolism (VTE) among the following:

- Age = 75 years;

- Active cancer or myeloproliferative disorders (having received treatment for
cancer within the last 6 months);

- Previous VTE;

- Obesity;

- Oral hormone therapy (antiandrogen or estrogen);

- Chronic heart failure;

- Chronic respiratory failure.
Minimum age
40 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Previous surgery with general anesthesia within 30 days before inclusion in the study;

- Patient requiring a curative anticoagulant or thrombolytic treatment;

- Patient at risk of bleeding;

- Stroke;

- Known hypersensitivity to heparin or enoxaparin sodium;

- 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
Terminated
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
Austria
State/province [2] 0 0
Wien
Country [3] 0 0
Canada
State/province [3] 0 0
Laval
Country [4] 0 0
Czech Republic
State/province [4] 0 0
Praha
Country [5] 0 0
Estonia
State/province [5] 0 0
Tallinn
Country [6] 0 0
France
State/province [6] 0 0
Paris
Country [7] 0 0
Germany
State/province [7] 0 0
Berlin
Country [8] 0 0
Hungary
State/province [8] 0 0
Budapest
Country [9] 0 0
India
State/province [9] 0 0
Mumbai
Country [10] 0 0
Italy
State/province [10] 0 0
Milano
Country [11] 0 0
Korea, Republic of
State/province [11] 0 0
Seoul
Country [12] 0 0
Latvia
State/province [12] 0 0
Riga
Country [13] 0 0
Lithuania
State/province [13] 0 0
Vilnius
Country [14] 0 0
Mexico
State/province [14] 0 0
Mexico
Country [15] 0 0
Netherlands
State/province [15] 0 0
Gouda
Country [16] 0 0
New Zealand
State/province [16] 0 0
Auckland
Country [17] 0 0
Romania
State/province [17] 0 0
Bucuresti
Country [18] 0 0
Russian Federation
State/province [18] 0 0
Moscow
Country [19] 0 0
Spain
State/province [19] 0 0
Barcelona
Country [20] 0 0
Ukraine
State/province [20] 0 0
Kiev
Country [21] 0 0
United Kingdom
State/province [21] 0 0
Guildford Surrey

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
primary prevention of Venous Thromboembolic Events [VTE] in patients hospitalized for acute
medical illness.

The secondary objectives were to evaluate the safety of AVE5026 and to document AVE5026
exposure in this population.
Trial website
https://clinicaltrials.gov/show/NCT00714597
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Patrick Mismetti, MD
Address 0 0
University Hospital of Saint-Etienne, France
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
For IPD and results data, please see https://clinicaltrials.gov/show/NCT00714597