NCT00839826

Brief Summary

Patients undergoing surgery, especially hip and knee surgery, are at high risk for VTE (up to 60 % without prophylaxis). The administration of drugs for thromboprophylaxis, such as heparins, significantly lowers that risk, but heparins have to be applied below the skin (subcutaneously). Additionally, there is a chance of developing a heparin-induced thrombocytopenia (decrease in platelets). Therefore, there is still a need for new agents which are safer and more efficient and which are easier to apply.The purpose of this study is to compare the safety and efficacy of BAY 59-7939 with the safety and efficacy of the licensed drug Enoxaparin. Enoxaparin, a so-called low molecular heparin, is approved and widely used in the area of thromboprophylaxis and will be given once daily subcutaneously.Another important purpose of the study is to find the optimal dose of BAY 59-7939 for thromboprophylaxis after hip replacement surgery. Therefore, there are several dose steps planned.

Trial Health

98
On Track

Trial Health Score

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

Enrollment
641

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2002

Shorter than P25 for phase_2

Geographic Reach
11 countries

41 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

December 1, 2002

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2003

Completed
5.3 years until next milestone

First Submitted

Initial submission to the registry

February 9, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 10, 2009

Completed
Last Updated

December 17, 2014

Status Verified

December 1, 2014

Enrollment Period

11 months

First QC Date

February 9, 2009

Last Update Submit

December 15, 2014

Conditions

ThromboembolismPrevention

Keywords

Prevention of Thromboembolism after total hip replacement

Outcome Measures

Primary Outcomes (1)

  • The primary efficacy endpoint is a composite endpoint of: - Any DVT (proximal and/or distal) and - Non fatal PE and - Death from all causes. The primary endpoint will be evaluated 5 - 9 days after surgery.

    Assymptomatic DVT will be measured 5-9 days after surgery Symptomatc DVT , non-fatal PE and Death from all causes will be measured 41 days after surgery

Secondary Outcomes (4)

  • Incidence of DVTs (total, proximal, distal)

    will be evaluated 5 - 9 days after surgery.

  • Incidence of symptomatic VTEs

    41 days after surgery

  • The composite endpoint that results from the primary endpoint by using alternative definition of deaths (i.e. VTE related death)

    41 days after surgery

  • Incidence of symptomatic VTEs (total, PE, DVT) within 30 days after stop of treatment with the study drug.

    41 days after surgery

Study Arms (2)

Arm 2

ACTIVE COMPARATOR
Drug: Enoxaparin

Arm 1

EXPERIMENTAL
Drug: Rivaroxaban (BAY59-7939)

Interventions

Rivaroxaban (BAY59-7939)DRUG

2,5 mg bid,5 mg bid,10mg bid, 20 mg bid, 20 mg tid, 30 mg bid, dose escalation trial

Arm 1
EnoxaparinDRUG

40 mg bid

Arm 2

Eligibility Criteria

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

You may qualify if:

  • Male patients aged 18 years or above and postmenopausal female patients.
  • Patients scheduled for elective primary total hip replacement (cemented or non-cemented prosthesis).
  • Patients' written informed consent for participation after receiving detailed written and oral previous information to any study specific procedures.

You may not qualify if:

  • DVT or PE within the previous 6 months prior to study entry.
  • Myocardial infarction (MI) or cerebrovascular attack (CVA), TIA or ischaemic stroke within the last 6 months prior to study entry.
  • History of heparin-induced thrombocytopenia, allergy to heparins.
  • Intracerebral or intraocular bleeding within the last 6 months prior to study entry.
  • History of gastrointestinal disease with gastrointestinal bleeding within the last 6 months prior to the study.
  • History or presence of gastrointestinal disease which could result in an impaired absorption of the study drug
  • Amputation of one leg.Related to current symptoms or findings
  • Heart insufficiency NYHA III-IV.
  • Congenital or acquired haemorrhagic diathesis (PT INR/aPTT not within normal limits).
  • Thrombocytopenia (platelets \< 50.000/µl).
  • Macroscopic haematuria.
  • Allergy to contrast media.
  • Severe hypertension (SBP \> 200mmHg, DBP \> 100 mmHg).
  • Impaired liver function (transaminases \> 2 x ULN).
  • Impaired renal function (serum creatinine \> 1.5 x ULN).
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (41)

Unknown Facility

Wiener Neustadt, Lower Austria, 2700, Austria

Location

Unknown Facility

Linz, Upper Austria, 4010, Austria

Location

Unknown Facility

Vienna, Vienna, 1220, Austria

Location

Unknown Facility

Baudour, 7331, Belgium

Location

Unknown Facility

Brussels, 1090, Belgium

Location

Unknown Facility

Ghent, 9000, Belgium

Location

Unknown Facility

Huy, 4500, Belgium

Location

Unknown Facility

Hellerup, 2900, Denmark

Location

Unknown Facility

Herlev, 2730, Denmark

Location

Unknown Facility

Hørsholm, DK-2970, Denmark

Location

Unknown Facility

Silkeborg, 8600, Denmark

Location

Unknown Facility

Amiens, 80030, France

Location

Unknown Facility

Lille, 59037, France

Location

Unknown Facility

Nancy, 54037, France

Location

Unknown Facility

Rheinfelden, Baden-Wurttemberg, 79618, Germany

Location

Unknown Facility

Fürth, Bavaria, 90766, Germany

Location

Unknown Facility

Garmisch-Partenkirchen, Bavaria, 82467, Germany

Location

Unknown Facility

Frankfurt am Main, Hesse, 60528, Germany

Location

Unknown Facility

Frankfurt am Main, Hesse, 65929, Germany

Location

Unknown Facility

Dresden, Saxony, 01307, Germany

Location

Unknown Facility

Berlin, State of Berlin, 14165, Germany

Location

Unknown Facility

Haifa, Israel, 31096, Israel

Location

Unknown Facility

Tel Aviv, 64239, Israel

Location

Unknown Facility

Tel Litwinsky, 52621, Israel

Location

Unknown Facility

Ẕerifin, 70300, Israel

Location

Unknown Facility

Amersfoort, 3818 ES, Netherlands

Location

Unknown Facility

Zwolle, 8025 AB, Netherlands

Location

Unknown Facility

Notodden, NO-3675, Norway

Location

Unknown Facility

Oslo, 0440, Norway

Location

Unknown Facility

Rjukan, NO-3660, Norway

Location

Unknown Facility

Bialystok, 15-276, Poland

Location

Unknown Facility

Gdansk, 80-742, Poland

Location

Unknown Facility

Krakow, 31-826, Poland

Location

Unknown Facility

Lodz, 91-425, Poland

Location

Unknown Facility

Lublin, 20-090, Poland

Location

Unknown Facility

Lublin, 20-718, Poland

Location

Unknown Facility

Warsaw, 00-909, Poland

Location

Unknown Facility

Gothenburg, 416 85, Sweden

Location

Unknown Facility

Jönköping, 551 85, Sweden

Location

Unknown Facility

Kungälv, 442 83, Sweden

Location

Unknown Facility

London, Greater London, SE5 9RS, United Kingdom

Location

MeSH Terms

Conditions

Thromboembolism

Interventions

RivaroxabanEnoxaparin

Condition Hierarchy (Ancestors)

Embolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsMorpholinesOxazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeparin, Low-Molecular-WeightHeparinGlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2009

First Posted

February 10, 2009

Study Start

December 1, 2002

Primary Completion

November 1, 2003

Study Completion

November 1, 2003

Last Updated

December 17, 2014

Record last verified: 2014-12

Locations

FR(3)NL(2)DK(4)IL(4)NO(3)GB(1)AU(3)BE(4)DE(7)SE(3)PL(7)