Evaluation of AVE5026 in the Prevention of Venous Thromboembolism in Acutely Ill Medical Patients With Restricted Mobility

Venous Thromboembolism Clinical Trial

— SAVE-VEMED  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00714597
• Other study ID #: EFC10572
• Secondary ID: 2008-000228-13
• Status: Terminated
• Phase: Phase 3
• First received: July 9, 2008
• Last updated: January 14, 2013
• Start date: July 2008
• Est. completion date: March 2009

Study information

• Verified date: January 2013
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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.

The secondary objectives were to evaluate the safety of AVE5026 and to document AVE5026 exposure in this population.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 421
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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.

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Thromboembolism
• Venous Thromboembolism

Intervention

Drug:
• Semuloparin sodium
0.4 mL (0.2 mL if SRI) solution in ready-to-use 0.5 ml pre-filled syringe Subcutaneous injection
• Enoxaparin sodium
0.4 mL (0.2 mL if SRI) solution in ready-to-use 0.5 ml pre-filled syringe Subcutaneous injection

Locations

Country	Name	City	State
Australia	sanofi-aventis Australia & New Zealand administrative office	Macquarie Park	New South Wales
Austria	Sanofi-Aventis Administrative Office	Wien
Canada	Sanofi-Aventis Administrative Office	Laval
Czech Republic	Sanofi-Aventis Administrative Office	Praha
Estonia	Sanofi-Aventis Administrative Office	Tallinn
France	Sanofi-Aventis Administrative Office	Paris
Germany	Sanofi-Aventis Administrative Office	Berlin
Hungary	Sanofi-Aventis Administrative Office	Budapest
India	Sanofi-Aventis Administrative Office	Mumbai
Italy	Sanofi-Aventis Administrative Office	Milano
Korea, Republic of	Sanofi-Aventis Administrative Office	Seoul
Latvia	Sanofi-Aventis Administrative Office	Riga
Lithuania	Sanofi-Aventis Administrative Office	Vilnius
Mexico	Sanofi-Aventis Administrative Office	Mexico
Netherlands	Sanofi-Aventis Administrative Office	Gouda
New Zealand	Sanofi-Aventis Administrative Office	Auckland
Romania	Sanofi-Aventis Administrative Office	Bucuresti
Russian Federation	Sanofi-Aventis Administrative Office	Moscow
Spain	Sanofi-Aventis Administrative Office	Barcelona
Ukraine	Sanofi-Aventis Administrative Office	Kiev
United Kingdom	Sanofi-Aventis Administrative Office	Guildford Surrey
United States	Sanofi-Aventis Administrative Office	Bridgewater	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Canada,  Czech Republic,  Estonia,  France,  Germany,  Hungary,  India,  Italy,  Korea, Republic of,  Latvia,  Lithuania,  Mexico,  Netherlands,  New Zealand,  Romania,  Russian Federation,  Spain,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From randomization up to 15 days after randomization or the day of the mandatory Compression Ultrasound (CUS), whichever came first	No
Secondary	Percentage of Participants Who Experienced asymptomatic proximal DVT		From randomization up to 15 days after randomization or the day of the mandatory CUS, whichever came first.	No
Secondary	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".	From 1st study drug injection up to 3 days after last study drug injection	Yes
Secondary	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.	From randomization up to 15 days after randomization or the day of mandatory CUS, whichever came first	No