NCT00331838|CompletedPhase 2DMC

Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Knee Replacement Surgery

TREK

A Multicenter, Randomized, Double-Blind, Double-Dummy, Parallel Group, Dose Response Study of Subcutaneous AVE5026 With an Enoxaparin Calibrator Arm in the Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Knee Replacement Surgery

Sanofi ClinicalTrials.gov

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2 other identifiers

DRI62432005-006202-26

Study Type

interventional

Target

705

Locations

19 countries

Sites

Timeline

RegisteredMay 2006

StartedMay 2006

CompletionJun 2007

Brief Summary

The primary objective was to demonstrate the dose-response of Semuloparin sodium (AVE5026) for the prevention of Venous Thromboembolism \[VTE\] in patients undergoing total knee replacement \[TKR\] surgery. Secondary objectives were to evaluate the safety (incidence of major bleeding) of AVE5026, to document the efficacy and safety of AVE5026 post-operative regimens, and to assess the pharmacokinetic parameters of AVE5026.

Trial Health

On Track

Trial Health Score

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

Enrollment

705

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started May 2006

Shorter than P25 for phase_2

Geographic Reach

19 countries

19 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

1.1 years study duration

Study Start

First participant enrolled

May 1, 2006

Completed

17 days until next milestone

First Submitted

Initial submission to the registry

May 18, 2006

Completed

13 days until next milestone

First Posted

Study publicly available on registry

May 31, 2006

Completed

1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed

Last Updated

January 15, 2013

Status Verified

January 1, 2013

Enrollment Period

1.1 years

First QC Date

May 18, 2006

Last Update Submit

January 14, 2013

Conditions

Venous Thromboembolism

Keywords

PreventionVenous ThrombosisOrthopedic Surgery

Outcome Measures

Primary Outcomes (1)

Number of Participants Who Experienced Venous Thromboembolism Event (VTE) or VTE-related Death
VTE included any Deep Vein Thrombosis \[DVT\] identified on mandatory venography of the lower limbs; symptomatic DVT and/or non-fatal pulmonary embolism \[PE\] before mandatory examination; VTE related deaths included fatal PE or deaths which could not be attributed to a documented cause and for which PE could not be ruled out. All events were to be confirmed by a Central Independent Adjudication Committee \[CIAC\] based on venographies, scheduled or unscheduled, and other available diagnostic tests (ultrasonography, ventilation/perfusion lung scan, pulmonary angiography, autopsy report, etc).
From surgery to Day 11 or the day of mandatory venography, whichever came first

Secondary Outcomes (4)

Number of Participants Who Experienced DVT
From surgery up to Day 11 or the day of mandatory venography, whichever came first
Number of Participants Who Experienced Symptomatic VTE
From surgery up to Day 11 or the day of mandatory venography, whichever came first
Number of Participants Who Experienced Bleedings
From 1st study drug injection up to 3 days after last study drug injection (median duration of approximately 11 days)
Number of Participants Who Required Initiation of Curative Anticoagulant or Thrombolytic Treatment After VTE Assessment
From surgery up to Day 11 or the day of mandatory venography, whichever came first

Other Outcomes (3)

Number of Deaths
From 1st study drug injection up to 3 days after last study drug injection (median duration of approximately 11 days)
Platelets Count: Number of Participants With Potentially Clinically Significant Abnormalities [PCSA]
From 1st study drug injection up to 3 days after last study drug injection (median duration of approximately 11 days)
Liver Function: Number of Participants With Potentially Clinically Significant Abnormalities [PCSA]
From 1st study drug injection up to 3 days after last study drug injection (median duration of approximately 11 days)

Study Arms (8)

Semuloparin 5 mg

EXPERIMENTAL

Semuloparin sodium 5 mg + Placebo (for Enoxaparin sodium) once daily for 4-10 days with an initial dose given 12 hours before or 8 hours after surgery depending on the willingness of the investigator

Drug: Semuloparin sodiumDrug: Placebo (for Enoxaparin sodium)

Semuloparin 10 mg

EXPERIMENTAL

Semuloparin sodium 10 mg + Placebo (for Enoxaparin sodium) once daily for 4-10 days with an initial dose given 12 hours before or 8 hours after surgery depending on the willingness of the investigator

Drug: Semuloparin sodiumDrug: Placebo (for Enoxaparin sodium)

Semuloparin 20 mg

EXPERIMENTAL

Semuloparin sodium 20 mg + Placebo (for Enoxaparin sodium) once daily for 4-10 days with an initial dose given 12 hours before or 8 hours after surgery depending on the willingness of the investigator

Drug: Semuloparin sodiumDrug: Placebo (for Enoxaparin sodium)

Semuloparin 40 mg

EXPERIMENTAL

Semuloparin sodium 40 mg + Placebo (for Enoxaparin sodium) once daily for 4-10 days with an initial dose given 12 hours before or 8 hours after surgery depending on the willingness of the investigator

Drug: Semuloparin sodiumDrug: Placebo (for Enoxaparin sodium)

Semuloparin 60 mg

EXPERIMENTAL

Semuloparin sodium 60 mg + Placebo (for Enoxaparin sodium) once daily for 4-10 days with an initial dose given 12 hours before or 8 hours after surgery depending on the willingness of the investigator

Drug: Semuloparin sodiumDrug: Placebo (for Enoxaparin sodium)

Enoxaparin 40 mg

ACTIVE COMPARATOR

Enoxaparin sodium 40 mg + Placebo (for Semuloparin sodium) once daily for 4-10 days with an initial dose given 12 hours before or 8 hours after surgery depending on the willingness of the investigator

Drug: Enoxaparin sodiumDrug: Placebo (for Semuloparin sodium)

Placebo pre-op / Semuloparin 20 mg

EXPERIMENTAL

Placebo (for Semuloparin sodium) + Placebo (for Enoxaparin sodium) 12 hours before surgery then, Semuloparin sodium 20 mg + Placebo (for Enoxaparin sodium) once daily for 4-10 days with an initial dose given 8 hours after surgery

Drug: Semuloparin sodiumDrug: Placebo (for Enoxaparin sodium)Drug: Placebo (for Semuloparin sodium)

Placebo pre-op / Semuloparin 40 mg

EXPERIMENTAL

Placebo (for Semuloparin sodium) + Placebo (for Enoxaparin sodium) 12 hours before surgery then, Semuloparin sodium 40 mg + Placebo (for Enoxaparin sodium) once daily for 4-10 days with an initial dose given 8 hours after surgery

Drug: Semuloparin sodiumDrug: Placebo (for Enoxaparin sodium)Drug: Placebo (for Semuloparin sodium)

Interventions

Semuloparin sodiumDRUG

0.8 mL solution in Type I amber glass vials Subcutaneous injection

Also known as: AVE5026

Placebo pre-op / Semuloparin 20 mgPlacebo pre-op / Semuloparin 40 mgSemuloparin 10 mgSemuloparin 20 mgSemuloparin 40 mgSemuloparin 5 mgSemuloparin 60 mg

Placebo (for Enoxaparin sodium)DRUG

0.4 mL solution in ready-to-use prefilled syringe strictly identical in appearance containing the same volume but without active component Subcutaneous injection

Placebo pre-op / Semuloparin 20 mgPlacebo pre-op / Semuloparin 40 mgSemuloparin 10 mgSemuloparin 20 mgSemuloparin 40 mgSemuloparin 5 mgSemuloparin 60 mg

Enoxaparin sodiumDRUG

0.4 mL solution in ready-to-use pre-filled syringe Subcutaneous injection

Also known as: Lovenox®

Enoxaparin 40 mg

Placebo (for Semuloparin sodium)DRUG

0.8 ml solution in type I amber glass vials strictly identical in appearance containing the same volume but without active component Subcutaneous injection

Enoxaparin 40 mgPlacebo pre-op / Semuloparin 20 mgPlacebo pre-op / Semuloparin 40 mg

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

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

You may qualify if:

Patient scheduled to undergo elective total knee replacement or revision of a primary procedure performed ≥ 6 months prior to study entry.

You may not qualify if:

Any major orthopedic surgery in the 3 months prior to study entry;
Clinical signs or symptoms of DVT or PE within the last 12 months or known post-phlebitic syndrome;
Known sensitivity to iodine or contrast dyes;
Recent stroke or myocardial infarction;
High risk of bleeding;
Treatment with other anti-thrombotic agents within 7 days prior to surgery;
Any contra-indication to Unfractionated Heparin or Low Molecular Weight Heparin;
Pregnant or nursing woman, or woman of childbearing potential who is not using an effective contraceptive method.
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.