NCT00709904|CompletedPhase 3DMC

Evaluation of AVE5026 as Compared to Placebo for the Extended Prophylaxis of Venous Thromboembolism in Patients Having Undergone Hip Fracture Surgery

SAVE-HIP3

A Multinational, Multicenter, Randomized, Double-Blind Study Comparing the Efficacy and Safety of AVE5026 With Placebo for the Extended Prevention of Venous Thromboembolism in Patients Having Undergone Hip Fracture Surgery

Sanofi ClinicalTrials.gov

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2 other identifiers

EFC106362007-007947-28

Study Type

interventional

Target

469

Locations

16 countries

Sites

Timeline

RegisteredJul 2008

StartedJun 2008

CompletionJan 2010

Brief Summary

The primary objective is to evaluate the efficacy of once daily (QD) subcutaneous (SC) injections of Semuloparin sodium (AVE5026) versus placebo for 3 additional weeks following an initial 7 to 10-day venous thromboprophylaxis with open-label AVE5026 in patients having undergone hip fracture surgery. The secondary objective is to evaluate the safety of extended AVE5026 administration.

Trial Health

On Track

Trial Health Score

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

Enrollment

469

participants targeted

Target at P50-P75 for phase_3

Timeline

Completed

Started Jun 2008

Geographic Reach

16 countries

16 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

1.6 years study duration

Study Start

First participant enrolled

June 1, 2008

Completed

1 month until next milestone

First Submitted

Initial submission to the registry

July 1, 2008

Completed

2 days until next milestone

First Posted

Study publicly available on registry

July 3, 2008

Completed

1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed

Last Updated

June 14, 2013

Status Verified

June 1, 2013

Enrollment Period

1.6 years

First QC Date

July 1, 2008

Last Update Submit

June 6, 2013

Conditions

Venous Thromboembolism

Keywords

venous thromboprophylaxisprimary preventionorthopedic surgery

Outcome Measures

Primary Outcomes (1)

Percentage of Participants Who Experience Venous Thromboembolism Events (VTE) or Death From Any Cause During the Extension Treatment Period
VTE include any Deep Vein Thrombosis (DVT) (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 suspected VTE. All-cause deaths include fatal PE and deaths for other reason than PE.
From randomization up to 24 days after randomization or the day of mandatory venography, whichever comes first

Secondary Outcomes (3)

Percentage of Participants Who Experience "Major" VTE or Death From Any Cause
From randomization up to 24 days after randomization or the day of mandatory venography, whichever comes first
Percentage of Participants Who Experience Clinically Relevant Bleedings During the Extension Treatment Period
From 1st study drug injection in the extension treatment period up to 3 days after last study drug injection
Percentage of Participants Who Require the Initiation of Curative Anticoagulant or Thrombolytic Treatment After VTE Assessment During the Extension Treatment Period
From randomization up to 24 days after randomization or the day of mandatory venography, whichever comes first

Other Outcomes (4)

Overview of Reported Bleeding Adverse Event
From 1st study drug injection up to 3 days after last study drug injection
Overview of Deaths
From 1st study drug injection up to 3 days after last study drug injection
Platelets Count: Percentage of Participants With Potentially Clinically Significant Abnormalities (PCSA)
From 1st study drug injection up to 3 days after last study drug injection
+1 more other outcomes

Study Arms (2)

Semuloparin extension treatment

EXPERIMENTAL

Extension treatment with Semuloparin sodium 20 mg (10 mg if SRI) for 19-23 days following initial treatment with open-label Semuloparin 20 mg (10 mg if SRI) for 7-10 days.

Drug: Open-label Semuloparin sodiumDrug: Semuloparin sodium

Placebo extension treatment

PLACEBO COMPARATOR

Extension treatment with placebo (for Semuloparin sodium) for 19-23 days following initial treatment with open-label Semuloparin 20 mg (10 mg if SRI) for 7-10 days

Drug: Open-label Semuloparin sodiumDrug: Placebo (for Semuloparin sodium)

Interventions

Open-label Semuloparin sodiumDRUG

0.4 mL (0.2 mL if SRI) solution in ready-to-use 0.5 ml pre-filled syringe Subcutaneous injection once daily with an initial dose given 8 hours after surgery

Also known as: AVE5026

Placebo extension treatmentSemuloparin extension treatment

Placebo (for Semuloparin sodium)DRUG

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

Placebo extension treatment

Semuloparin sodiumDRUG

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

Also known as: AVE5026

Semuloparin extension treatment

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

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

You may qualify if:

In the run-in phase:
Standard surgery for fracture of the upper third of the femur, including femoral head and neck
In the double-blind phase following the run-in phase:
Completion of the run-in phase without permanent treatment discontinuation

You may not qualify if:

Any major orthopedic surgery within 3 months prior to enrolment;
Deep vein thrombosis or pulmonary embolism within the last 12 months, or known post-phlebitic syndrome;
High risk of bleeding;
Known hypersensitivity to heparins;
Any contraindication to the performance of venography;
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.