NCT00721760|CompletedPhase 3DMC

Evaluation of AVE5026 as Compared to Enoxaparin for the Prevention of Thromboembolism in Patients Undergoing Hip Fracture Surgery

SAVE-HIP2

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 Hip Fracture Surgery

Sanofi ClinicalTrials.gov

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2 other identifiers

EFC103432007-007945-11

Study Type

interventional

Target

1,003

Locations

25 countries

Sites

Timeline

RegisteredJul 2008

StartedJul 2008

CompletionOct 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 prevention of Venous Thromboembolic Events \[VTE\] in patients undergoing hip fracture surgery. The secondary objectives were to evaluate the safety of AVE5026 in patients undergoing hip fracture surgery, and to document AVE5026 exposure in this population.

Trial Health

On Track

Trial Health Score

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

Enrollment

1,003

participants targeted

Target at P75+ for phase_3

Timeline

Completed

Started Jul 2008

Shorter than P25 for phase_3

Geographic Reach

25 countries

25 active sites

Status

completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.3 years study duration

Study Start

First participant enrolled

July 1, 2008

Completed

21 days until next milestone

First Submitted

Initial submission to the registry

July 22, 2008

Completed

2 days until next milestone

First Posted

Study publicly available on registry

July 24, 2008

Completed

1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed

Last Updated

January 23, 2013

Status Verified

January 1, 2013

Enrollment Period

1.3 years

First QC Date

July 22, 2008

Last Update Submit

January 14, 2013

Conditions

Venous Thromboembolism

Keywords

Hip fracturesHeparin Low-Molecular-WeightRandomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

Percentage of Participants Who Experienced Venous Thromboembolism Event [VTE] or All-cause Death
VTE included any Deep Vein Thrombosis \[DVT\] (proximal or distal, symptomatic or not) and non-fatal Pulmonary Embolism \[PE\] as confirmed by a Central Independent Adjudication Committee \[CIAC\] after review of mandatory bilateral venograms and diagnostic tests for VTE. All-cause deaths included fatal PE and deaths for other reason than PE.
From randomization up to 10 days after surgery or the day of mandatory venography, whichever came first

Secondary Outcomes (3)

Percentage of Participants Who Experienced "Major" VTE or All-cause Death
From randomization up to 10 days after surgery or the day of mandatory venography, whichever came first
Percentage of Participants Who Experienced Clinically Relevant Bleedings
From first 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 10 days after surgery or the day of mandatory venography, whichever came first

Other Outcomes (3)

Overview of deaths
From first study drug injection up to 3 days after last study drug injection
Platelets Count: Percentage of Participants With Potentially Clinically Significant Abnormalities [PCSA]
From first study drug injection up to 3 days after last study drug injection
Liver Function: Percentage of Participants With Potentially Clinically Significant Abnormalities [PCSA]
From first study drug injection up to 3 days after last study drug injection

Study Arms (2)

Semuloparin

EXPERIMENTAL

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

Drug: Semuloparin sodiumDrug: Placebo

Enoxaparin

ACTIVE COMPARATOR

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

Drug: Enoxaparin sodiumDrug: Placebo

Interventions

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

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

PlaceboDRUG

0.4 mL (0.2 mL if SRI) solution in ready-to-use 0.5 ml prefilled syringe strictly identical in appearance but without active component Subcutaneous injection

EnoxaparinSemuloparin

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

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

You may qualify if:

Standard surgery for fracture of the upper third of the femur including femoral head and neck.

You may not qualify if:

Estimated time of injury/fracture \> 24 hours before admission to hospital;
Any major orthopedic surgery in the 3 months prior to study start;
Multiple trauma affecting more than one organ system;
Deep vein thrombosis or pulmonary embolism within the last 12 months or known post-phlebitic syndrome;
High risk of bleeding;
Known allergy to heparin, or enoxaparin, or pork products;
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.