Expired Study
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Bridgewater, New Jersey 08807


Purpose:

The primary objective of the study is to compare the efficacy of AVE5026 with Enoxaparin for the prevention of Venous Thromboembolic Events (VTE) in patients undergoing elective knee replacement surgery. The secondary objectives of this study are to evaluate the safety of AVE5026 in patients undergoing elective knee replacement surgery, and to document AVE5026 exposure in this population.


Study summary:

The total duration of observation per patient is 35 - 42 days from surgery, and includes: - a treatment period of 7 - 10 days, - a follow-up period of 28 - 35 days. Mandatory bilateral venography is performed 7 to 11 days after surgery.


Criteria:

Inclusion Criteria: - Knee replacement surgery or revision of at least one component of a knee prosthesis implanted ≥ 6 months prior to study entry. Exclusion Criteria: - Any major orthopedic surgeries in the 3 months prior to study. - Deep vein thrombosis or pulmonary embolism within the last 12 months, or known post-phlebitic syndrome. - Any contraindications to the performance of venography. - Patients at high risk of bleeding. - Know allergy to heparin, or enoxaparin, or pork products. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.


Study is Available At:


Original ID:

EFC10571


NCT ID:

NCT00718224


Secondary ID:

2007-007946-37


Study Acronym:

SAVE-KNEE


Brief Title:

Evaluation of AVE5026 as Compared to Enoxaparin for the Prevention of Thromboembolism in Patients Undergoing Elective Knee Replacement Surgery


Official Title:

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 Elective Knee Replacement Surgery


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Sanofi-Aventis


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

1150


Enrollment Type:

Actual


Overall Contact Information

Official Name:Michael R. LASSEN, MD
Principal Investigator
Horsholm Hospital, Horsholm, Denmark

Study Dates

Start Date:July 2008
Completion Date:May 2009
Completion Type:Actual
Primary Completion Date:May 2009
Primary Completion Type:Actual
Verification Date:July 2011
Last Changed Date:July 21, 2011
First Received Date:July 17, 2008

Study Outcomes

Outcome Type:Primary Outcome
Measure:Occurence of the composite endpoint of any VTE confirmed by a blinded Central Independent Adjudication Committee (CIAC) and deaths from any cause
Time Frame:From randomization up to Day 11 or the day of mandatory venography, whichever comes first
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Occurence of the composite endpoint of any proximal Deep Vein Thrombosis (DVT), symptomatic distal DVT, non-fatal Pulmonary Embolism (PE), and all cause deaths
Time Frame:From randomization up to Day 11 or the day of mandatory venography, whichever comes first
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Number of patients with major bleedings and clinically relevant non-major bleedings as confirmed by the CIAC
Time Frame:Up to a maximum of 42 days
Safety Issues:True
Outcome Type:Secondary Outcome
Measure:Number of patients requiring the initiation of curative anticoagulant or thrombolytic treatment after VTE assessment
Time Frame:Up to a maximum of 42 days
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Semuloparin sodium (AVE5026)
Description:Form: solution in ready-to-use prefilled syringe Route: subcutaneous injection
Arm Name:AVE5026
Intervention Type:Drug
Name:Enoxaparin
Description:Form: solution in ready-to-use prefilled syringe Route: subcutaneous injection
Arm Name:Enoxaparin
Intervention Type:Drug
Name:Placebo
Description:Form: solution in ready-to-use prefilled syringe Route: subcutaneous injection
Arm Name:AVE5026

Study Arms

Study Arm Type:Experimental
Arm Name:AVE5026
Description:AVE5026, once daily starting 8 hours after surgery. Matching placebo, 12 hours after surgery then once daily. AVE5026 dose was reduced (and matching placebo was administered 12 hours after surgery only) in patients with severe renal impairment.
Study Arm Type:Active Comparator
Arm Name:Enoxaparin
Description:Enoxaparin, 30 mg twice daily starting 12 hours after surgery. Matching placebo, 8 hours after surgery. Enoxaparin dose was reduced to 20 mg once daily in patients with severe renal impairment.

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Sanofi-Aventis

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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