Venous ThromboembolismPhase 3SAVE-VEMEDNCT00714597
Evaluation of AVE5026 in the Prevention of Venous Thromboembolism in Acutely Ill Medical Patients With Restricted Mobility
A Phase 3 study testing Semuloparin sodium and Enoxaparin sodium in people with Venous Thromboembolism, run by Sanofi at 22 sites in 22 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Venous Thromboembolism
- What is being tested?
- Semuloparin sodium and Enoxaparin sodium
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 421 participants
- Where
- 22 sitesin 22 countries
- Study dates
- Jul 2008to Mar 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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*.
Show all 14Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
22 sites in 22 countries.
22 sites in 22 countries
United States1 site
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, 08807
Australia1 site
sanofi-aventis Australia & New Zealand administrative office
Macquarie Park, New South Wales
United Kingdom1 site
Sanofi-Aventis Administrative Office
Guildford Surrey
About this study
Official 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
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.
Read the detailed description
Randomization had to take place just prior to the first study drug injection.
The total duration of observation per participant was 35-42 days from randomization broken down as follows:
- 10 to 14-day double-blind treatment period;
- 25 to 32-day follow-up period.
Mandatory bilateral compression ultrasound [CUS] had to be performed between 10 to 15 days after randomization.
- Conditions
- Venous Thromboembolism
- Being tested
- Semuloparin sodium, Enoxaparin sodium
- Keywords
- Venous thrombosis, Primary prevention
- Medical subject headings
- Venous Thromboembolism, Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semuloparin sodiumDrug
Also called AVE5026
0.4 mL (0.2 mL if SRI) solution in ready-to-use 0.5 ml pre-filled syringe
Subcutaneous injection
Enoxaparin sodiumDrug
Also called Lovenox®
0.4 mL (0.2 mL if SRI) solution in ready-to-use 0.5 ml pre-filled syringe
Subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Semuloparin | Experimental | Semuloparin sodium 20 mg (10 mg if Severe Renal Impairment [SRI]) once daily for 10-14 days Receives: Drug: Semuloparin sodium |
| Enoxaparin | Active comparator | Enoxaparin sodium 40 mg (20 mg if Severe Renal Impairment [SRI]) once daily for 10-14 days Receives: Drug: Enoxaparin sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From randomization up to 15 days after randomization or the day of the mandatory Compression Ultrasound (CUS), whichever came first
Secondary outcomes (3)
Percentage of Participants Who Experienced asymptomatic proximal DVT
Measured: From randomization up to 15 days after randomization or the day of the mandatory CUS, whichever came first.
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".
Measured: From 1st study drug injection up to 3 days after last study drug injection
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.
Measured: From randomization up to 15 days after randomization or the day of mandatory CUS, whichever came first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2008 (estimated)
- Study startJul 2008
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 421 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Patrick Mismetti, MD, Principal investigator, University Hospital of Saint-Etienne, FranceAlexander Turpie, MD, Study chair, HHS-General Hospital, Hamilton, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00714597
- Sponsor's protocol ID
- EFC10572
- Other IDs
- 2008-000228-13, 2008
- Acronym
- SAVE-VEMED
- Status last verified
- Jan 2013
- First submitted
- 9 Jul 2008
- Last updated
- 23 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT00714597
- Acronym / sponsor ID
- SAVE-VEMED / EFC10572
- Conditions
- Venous Thromboembolism
- Keywords
- Venous thrombosis, Primary prevention
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 421 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 14 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Randomization had to take place just prior to the first study drug injection.
The total duration of observation per participant was 35-42 days from randomization broken down as follows:
- 10 to 14-day double-blind treatment period;
- 25 to 32-day follow-up period.
Mandatory bilateral compression ultrasound [CUS] had to be performed between 10 to 15 days after randomization.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Semuloparin | Experimental | Drug: Semuloparin sodiumSemuloparin sodium 20 mg (10 mg if Severe Renal Impairment [SRI]) once daily for 10-14 days |
| Enoxaparin | Active comparator | Drug: Enoxaparin sodiumEnoxaparin sodium 40 mg (20 mg if Severe Renal Impairment [SRI]) once daily for 10-14 days |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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*;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Semuloparin sodiumAlso: AVE50260.4 mL (0.2 mL if SRI) solution in ready-to-use 0.5 ml pre-filled syringe Subcutaneous injection | Drug | Semuloparin |
| Enoxaparin sodiumAlso: Lovenox®0.4 mL (0.2 mL if SRI) solution in ready-to-use 0.5 ml pre-filled syringe Subcutaneous injection | Drug | Enoxaparin |
Primary outcome
Percentage of Participants Who Experienced Venous Thromboembolism Event (VTE) or VTE-related Death
Time frame: From randomization up to 15 days after randomization or the day of the mandatory Compression Ultrasound (CUS), whichever came first
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.
3 secondary outcomes
Percentage of Participants Who Experienced asymptomatic proximal DVT
Time frame: From randomization up to 15 days after randomization or the day of the mandatory CUS, whichever came first.
Percentage of Participants Who Experienced Clinically Relevant Bleedings
Time frame: From 1st study drug injection up to 3 days after last study drug injection
Percentage of Participants Who Required the Initiation of Curative Anticoagulant or Thrombolytic Treatment After VTE Assessment
Time frame: From randomization up to 15 days after randomization or the day of mandatory CUS, whichever came first
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2013.
Related trials for Venous Thromboembolism
RecruitingPhase 3
REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults
Venous Thromboembolism (VTE)
RecruitingPhase 3
Treatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants With Solid and Hematologic Cancers
Venous Thromboembolism (VTE)
RecruitingPhase 3
REGN7508 in Adult Participants for Prevention of Cancer-Associated Thrombosis
Cancer-Associated Thrombosis (CAT)
RecruitingPhase 3
REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants
Symptomatic Venous Thromboembolism (VTE)
Recruiting
DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis
Venous Thromboembolism, Deep Venous Thrombosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick Mismetti, MD principal investigator
University Hospital of Saint-Etienne, France
Alexander Turpie, MD study chair
HHS-General Hospital, Hamilton, Canada
22 sites in 22 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Semuloparin sodium and Enoxaparin sodium in people with Venous Thromboembolism, run by Sanofi at 22 sites in 22 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States, Australia, Austria, Canada, Czechia and 17 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Who Experienced Venous Thromboembolism Event (VTE) or VTE-related Death (time frame: From randomization up to 15 days after randomization or the day of the mandatory Compression Ultrasound (CUS), whichever came first). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2013.