NCT00338897

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.

Trial Health

98
On Track

Trial Health Score

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

Enrollment
1,090

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 2006

Shorter than P25 for phase_2

Geographic Reach
14 countries

14 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

Study Start

First participant enrolled

May 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 19, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 20, 2006

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

December 10, 2008

Status Verified

December 1, 2008

Enrollment Period

1 year

First QC Date

June 19, 2006

Last Update Submit

December 9, 2008

Conditions

Venous Thromboembolism

Keywords

Venous ThromboembolismPreventionArthroplastyReplacementHiporthopedic surgery

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (2)

  • 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.

Interventions

SR123781ADRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Sanofi-Aventis

San Isidro, Buenos Aires, 1642, Argentina

Location

Sanofi-Aventis

Sofia, 1715, Bulgaria

Location

Sanofi-Aventis

Providencia, Santiago Metropolitan, Chile

Location

Sanofi-Aventis

Bogotá, Colombia

Location

Sanofi-Aventis

Prague, 160 00, Czechia

Location

Sanofi-Aventis

Denmark, Denmark

Location

Sanofi-Aventis

Helsinki, Finland

Location

Sanofi-Aventis

México, 04000, Mexico

Location

Sanofi-Aventis

Oslo, Norway

Location

Sanofi-Aventis

Warsaw, Poland

Location

Sanofi-Aventis

Bucharest, 70334, Romania

Location

Sanofi-Aventis

Moscow, 101000, Russia

Location

Sanofi-Aventis

Bromma, Sweden

Location

Sanofi-Aventis

Istanbul, 34394, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    PMID: 18402906DERIVED

Related Links

MeSH Terms

Conditions

Venous Thromboembolism

Interventions

SR 123781A

Condition Hierarchy (Ancestors)

ThromboembolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Michael Rud Lassen, MD

    Hoersholm Hospital, Spine Clinic, Usserod Kongevej 102, DK-2970 Hoerholm, Denmark

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 19, 2006

First Posted

June 20, 2006

Study Start

May 1, 2006

Primary Completion

May 1, 2007

Study Completion

May 1, 2007

Last Updated

December 10, 2008

Record last verified: 2008-12

Locations

AR(1)FI(1)RO(1)NO(1)BU(1)RU(1)CZ(1)CO(1)TU(1)PL(1)DK(1)SE(1)ME(1)CL(1)