NCT00714597|TerminatedPhase 3DMC

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

SAVE-VEMED

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

Sanofi ClinicalTrials.gov

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2 other identifiers

EFC105722008-000228-13

Study Type

interventional

Target

421

Locations

20 countries

Sites

Timeline

RegisteredJul 2008

StartedJul 2008

CompletionMar 2009

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 Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

421

participants targeted

Target at P50-P75 for phase_3

Timeline

Completed

Started Jul 2008

Shorter than P25 for phase_3

Geographic Reach

20 countries

20 active sites

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

8 months study duration

Study Start

First participant enrolled

July 1, 2008

Completed

8 days until next milestone

First Submitted

Initial submission to the registry

July 9, 2008

Completed

5 days until next milestone

First Posted

Study publicly available on registry

July 14, 2008

Completed

8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed

Last Updated

January 23, 2013

Status Verified

January 1, 2013

Enrollment Period

8 months

First QC Date

July 9, 2008

Last Update Submit

January 14, 2013

Conditions

Venous Thromboembolism

Keywords

Venous thrombosisPrimary prevention

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (3)

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.
Percentage of Participants Who Experienced Clinically Relevant Bleedings
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
From randomization up to 15 days after randomization or the day of mandatory CUS, whichever came first

Study Arms (2)

Semuloparin

EXPERIMENTAL

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

Drug: Semuloparin sodium

Enoxaparin

ACTIVE COMPARATOR

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

Drug: Enoxaparin sodium

Interventions

Semuloparin sodiumDRUG

0.4 mL (0.2 mL if SRI) solution in ready-to-use 0.5 ml pre-filled syringe Subcutaneous injection

Also known as: AVE5026

Semuloparin

Enoxaparin sodiumDRUG

0.4 mL (0.2 mL if SRI) solution in ready-to-use 0.5 ml pre-filled syringe Subcutaneous injection

Also known as: Lovenox®

Enoxaparin

Eligibility Criteria

Age40 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

You may not qualify if:

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.

Contact the study team to confirm eligibility.