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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00338897
Recruitment Status : Completed
First Posted : June 20, 2006
Last Update Posted : December 10, 2008
Sponsor:
Information provided by:
Sanofi

Tracking Information
First Submitted Date  ICMJE June 19, 2006
First Posted Date  ICMJE June 20, 2006
Last Update Posted Date December 10, 2008
Study Start Date  ICMJE May 2006
Actual Primary Completion Date May 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 29, 2006)
The primary efficacy endpoint is a composite of total venous thromboembolic events (VTE) including VTE related deaths during the treatment period.
Original Primary Outcome Measures  ICMJE
 (submitted: June 19, 2006)
The primary efficacy endpoint is a composite of total venous Thromboembolic Events (VTE) including VTE related deaths during the treatment period
Change History Complete list of historical versions of study NCT00338897 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 29, 2006)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 19, 2006)
  • Secondary efficacy endpoints will include all DVTs (proximal or distal) and all symptomatic VTEs (PEs or DVTs).
  • The main safety criteria is the incidence of major bleedings occurring from the first study drug administration to 3 calendar days after the last study drug administration
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dose Ranging Study in Elective Total Hip Replacement Surgery
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Venous Thromboembolism
Intervention  ICMJE Drug: SR123781A
Study Arms  ICMJE Not Provided
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 9, 2008)
1090
Original Enrollment  ICMJE
 (submitted: June 19, 2006)
1020
Actual Study Completion Date  ICMJE May 2007
Actual Primary Completion Date May 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden,   Argentina,   Bulgaria,   Chile,   Colombia,   Czech Republic,   Denmark,   Finland,   Mexico,   Norway,   Poland,   Romania,   Russian Federation,   Turkey
Removed Location Countries Brazil,   Croatia
 
Administrative Information
NCT Number  ICMJE NCT00338897
Other Study ID Numbers  ICMJE DRI5664
EudraCT : 2006-000152-41
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party ICD Study Director, sanofi-aventis
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Michael Rud Lassen, MD Hoersholm Hospital, Spine Clinic, Usserod Kongevej 102, DK-2970 Hoerholm, Denmark
PRS Account Sanofi
Verification Date December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP