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Dose Ranging Study in Elective Total Hip Replacement Surgery (DRIVE)

Primary Purpose

Venous Thromboembolism

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
SR123781A
Sponsored by
Sanofi
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Venous Thromboembolism focused on measuring Venous Thromboembolism, Prevention, Arthroplasty, Replacement, Hip, orthopedic surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients scheduled to undergo elective total hip replacement surgery or a revision of at least one component of a total hip replacement performed > 6 months prior to study entry Exclusion Criteria: Pregnant or nursing women, or women of childbearing potential who are not using an effective contraceptive method and who do not have a negative pregnancy test performed immediately before randomization Known progressive malignant disease Ischemic stroke in the last 3 months Myocardial infarction (MI) in the last 3 months Any major orthopedic surgery in the 3 months prior to study start Clinical signs or symptoms of DVT or PE within the last 12 months or symptoms of post phlebitic syndrome (these conditions may confound DVT/PE assessments) Treatment with other antithrombotic agents within 7 days prior to surgery

Sites / Locations

  • Sanofi-Aventis
  • Sanofi-Aventis
  • Sanofi-Aventis
  • Sanofi-Aventis
  • Sanofi-Aventis
  • Sanofi-Aventis
  • Sanofi-Aventis
  • Sanofi-Aventis
  • Sanofi-Aventis
  • Sanofi-Aventis
  • Sanofi-Aventis
  • Sanofi-Aventis
  • Sanofi-Aventis
  • Sanofi-Aventis

Outcomes

Primary Outcome Measures

The primary efficacy endpoint is a composite of total venous thromboembolic events (VTE) including VTE related deaths during the treatment period.

Secondary Outcome Measures

Secondary efficacy endpoints will include all deep vein thrombosis events [DVTs] (proximal or distal) and all symptomatic VTEs (pulmonary embolisms [PEs] or DVTs)
The main safety criterion is the incidence of major bleedings occurring from the first study drug administration to 3 calendar days after the last study drug administration.

Full Information

First Posted
June 19, 2006
Last Updated
December 9, 2008
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00338897
Brief Title
Dose Ranging Study in Elective Total Hip Replacement Surgery
Acronym
DRIVE
Official Title
A Multicenter, Randomized, Double-Blind, Double Dummy, Parallel Group, Dose Ranging Study of Subcutaneous SR123781A With an Enoxaparin Calibrator Arm in the Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Hip Replacement Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
May 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Sanofi

4. Oversight

5. Study Description

Brief Summary
The primary objective is to: demonstrate the efficacy of SR123781A in the prevention of venous thromboembolism (VTE) by the demonstration of a dose-response in patients undergoing total hip replacement surgery. The secondary objectives are to: evaluate the safety of SR123781A in the prevention of VTE after elective total hip replacement surgery; and to assess the SR123781A pharmacokinetic profile in patients undergoing elective total hip replacement surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Thromboembolism
Keywords
Venous Thromboembolism, Prevention, Arthroplasty, Replacement, Hip, orthopedic surgery

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1090 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
SR123781A
Primary Outcome Measure Information:
Title
The primary efficacy endpoint is a composite of total venous thromboembolic events (VTE) including VTE related deaths during the treatment period.
Secondary Outcome Measure Information:
Title
Secondary efficacy endpoints will include all deep vein thrombosis events [DVTs] (proximal or distal) and all symptomatic VTEs (pulmonary embolisms [PEs] or DVTs)
Title
The main safety criterion is the incidence of major bleedings occurring from the first study drug administration to 3 calendar days after the last study drug administration.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients scheduled to undergo elective total hip replacement surgery or a revision of at least one component of a total hip replacement performed > 6 months prior to study entry Exclusion Criteria: Pregnant or nursing women, or women of childbearing potential who are not using an effective contraceptive method and who do not have a negative pregnancy test performed immediately before randomization Known progressive malignant disease Ischemic stroke in the last 3 months Myocardial infarction (MI) in the last 3 months Any major orthopedic surgery in the 3 months prior to study start Clinical signs or symptoms of DVT or PE within the last 12 months or symptoms of post phlebitic syndrome (these conditions may confound DVT/PE assessments) Treatment with other antithrombotic agents within 7 days prior to surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Rud Lassen, MD
Organizational Affiliation
Hoersholm Hospital, Spine Clinic, Usserod Kongevej 102, DK-2970 Hoerholm, Denmark
Official's Role
Study Chair
Facility Information:
Facility Name
Sanofi-Aventis
City
San Isidro
State/Province
Buenos Aires
ZIP/Postal Code
1642
Country
Argentina
Facility Name
Sanofi-Aventis
City
Sofia
ZIP/Postal Code
1715
Country
Bulgaria
Facility Name
Sanofi-Aventis
City
Providencia
State/Province
Santiago
Country
Chile
Facility Name
Sanofi-Aventis
City
Santafe de Bogota
Country
Colombia
Facility Name
Sanofi-Aventis
City
Praha
ZIP/Postal Code
160 00
Country
Czech Republic
Facility Name
Sanofi-Aventis
City
Denmark
Country
Denmark
Facility Name
Sanofi-Aventis
City
Helsinki
Country
Finland
Facility Name
Sanofi-Aventis
City
Mexico
ZIP/Postal Code
04000
Country
Mexico
Facility Name
Sanofi-Aventis
City
Oslo
Country
Norway
Facility Name
Sanofi-Aventis
City
Warszawa
Country
Poland
Facility Name
Sanofi-Aventis
City
Bucuresti
ZIP/Postal Code
70334
Country
Romania
Facility Name
Sanofi-Aventis
City
Moscow
ZIP/Postal Code
101000
Country
Russian Federation
Facility Name
Sanofi-Aventis
City
Bromma
Country
Sweden
Facility Name
Sanofi-Aventis
City
Istanbul
ZIP/Postal Code
34394
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
18402906
Citation
Lassen MR, Dahl O, Mismetti P, Zielske D, Turpie AG. SR123781A: a new once-daily synthetic oligosaccharide anticoagulant for thromboprophylaxis after total hip replacement surgery: the DRIVE (Dose Ranging Study in Elective Total Hip Replacement Surgery) study. J Am Coll Cardiol. 2008 Apr 15;51(15):1498-504. doi: 10.1016/j.jacc.2008.03.007.
Results Reference
derived
Links:
URL
http://www.sanofi-aventis.com
Description
Related Info

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Dose Ranging Study in Elective Total Hip Replacement Surgery

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