check_circleStudy Completed

Venous Thromboembolism

Bayer Identifier:

10944

ClinicalTrials.gov Identifier:

NCT00398905

EudraCT Number:

Not Available

EU CT Number:

Not Available
Dose-ranging Study of BAY 59-7939 on the Prevention of VTE in patients Undergoing Elective Total Hip Replacement

Trial purpose

Patients undergoing surgery, especially hip and knee surgery, are at high risk for VTE. The administration of drugs for thromboprophylaxis, such as heparins, significantly lowers that risk, but heparins have to be applied by injections below the skin. The purpose of this study was to compare the safety and efficacy of BAY 59-7939 with the safety and efficacy of the licensed drug enoxaparin and to find the optimal dose of BAY 59-7939 for the anticipated phase III trials. Enoxaparin, a so-called low molecular weight heparin, is approved and widely used in the area of thromboprophylaxis and was given once daily subcutaneously. In this study 5 different doses of the investigational drug BAY 59-7939 were tested in comparison to Enoxaparin. The following doses of BAY 59-7939 were tested: 2.5 mg twice daily (5 mg total daily dose); 5 mg twice daily (10 mg total daily dose), 10 mg twice daily (20 mg total daily dose), 20 mg twice daily (40 mg total daily dose) and 30 mg twice daily ( 60 mg total daily dose). This study ran for approximately 7 months in a number of countries. In total, 726 patients were enrolled in this study.

Key Participants Requirements

Sex

Both

Age

18 Years
  • - 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
  • - Any VTE prior to randomization
    - Myocardial infarction (MI) or TIA or ischaemic stroke within the last 6 months prior to randomisation
    - History of heparin-induced thrombocytopenia, allergy to heparins
    - Intracerebral or intraocular bleeding within the last 6 months prior to randomisation
    - 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 (e.g. severe active inflammatory bowel disease, short gut syndrome)
    - Amputation of one leg
    - Heart insufficiency NYHA III-IV
    - Congenital or acquired haemorrhagic diathesis (PT INR/aPTT not within normal limits) including patients with acquired or congenital thrombopathy
    - Thrombocytopenia (platelets < 100.000/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 or creatinine clearance < 30 ml/min)
    - Active malignant disease
    - Presence of active peptic ulcer or gastrointestinal disease with increased risk of gastrointestinal bleeding
    - Body weight < 45 kg
    - Drug- or alcohol abuse
    - Patients who cannot stop therapy ( in the opinion of the investigator/ physician) with anticoagulants (e.g. phenprocoumon, warfarin-sodium, heparins and factor Xa inhibitors other than study medication) and fibrinolytic therapy should be excluded from the study
    - Therapy with acetylic salicylic acid or other thrombocyte aggregation inhibitors (e.g. clopidogrel, dipyridamole and ticlopidine) should be stopped one week before enrolment. Patients not able to stop ASA therapy will be excluded
    - All other drugs influencing coagulation, (exception: NSAIDs with half life < 17 hrs will be allowed)
    - Systemic and topical treatment with azole compounds (e.g. ketoconazole, fluconazole, itraconazole) and other strong CYP3A4 inhibitors e.g. HIV-protease inhibitors. Azole compounds and other strong CYP3A4 inhibitors
    - Therapy with another investigational product within 30 days prior start of study
    - Planned intermittent pneumatic compression during active treatment period
    - Planned epidural anaesthesia with indwelling epidural catheter (spinal or epidural anaesthesia without indwelling catheter are allowed)
    - Concomitant participation in another trial or study

Trial summary

Enrollment Goal
726
Trial Dates
January 2004 - September 2004
Phase
Phase 2
Could I Receive a placebo
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Krankenhaus der Barmherzigen Schwestern LinzLinz, 4010, Austria
Completed
Nordsjællands Hospital - HørsholmHørsholm, DK-2970, Denmark
Completed
Hospital Clínic i Provincial de BarcelonaBarcelona, 08036, Spain
Completed
Kings College HospitalLondon, SE5 9RS, United Kingdom
Completed
Helse Blefjell Rjukan sykehusRjukan, NO-3660, Norway
Completed
SU/ÖstraGöteborg, 416 85, Sweden
Completed
Allgem. öffentl. Krankenhaus Wiener NeustadtWiener Neustadt, 2700, Austria
Completed
Länssjukhuset RyhovJönköping, 551 85, Sweden
Terminated
Helios Klinikum Emil von BehringBerlin, 14165, Germany
Completed
Hospital Universitari Germans Trias i PujolBadalona, 08916, Spain
Completed
Assaf Harofeh Medical CenterZerifin, 70300, Israel
Completed
Lovisenberg Diakonale sykehusOslo, 0440, Norway
Completed
SP Szpital Kliniczny AM w BialymstokuBialystok, 15-276, Poland
Completed
LänssjukhusetHalmstad, 301 85, Sweden
Completed
Gentofte HospitalHellerup, 2900, Denmark
Completed
Hospital Clínico Universitario de ValenciaValencia, 46010, Spain
Terminated
RHMS Site Louis CatyBAUDOUR, 7331, Belgium
Completed
Klinikum Garmisch-PartenkirchenGarmisch-Partenkirchen, 82467, Germany
Completed
Hopital Roger Salengro - LilleLILLE CEDEX, 59037, France
Completed
Rambam Medical CenterHaifa, 31096, Israel
Terminated
Policlinico Universitario MontelucePerugia, 06122, Italy
Completed
Orbis Medisch CentrumSITTARD, 6131 BK, Netherlands
Completed
Samodzielny Publiczny Szpital Kliniczny nr 4Lublin, 20-090, Poland
Terminated
CHR de HuyHUY, 4500, Belgium
Terminated
Klinikum der Philipps-UniversitätMarburg, 35043, Germany
Completed
Regionshospitalet SilkeborgSilkeborg, 8600, Denmark
Completed
Ciutat Sanitària i Universitaria de la Vall d'HebrónBarcelona, 08035, Spain
Completed
Hôpital Nord - AmiensAMIENS, 80030, France
Completed
Chaim Sheba Medical CenterTel Hashomer, 52621, Israel
Completed
AUSL 1 Perugia - UmbriaGubbio, 06024, Italy
Completed
Tergooiziekenhuizen HilversumHILVERSUM, 1213 XZ, Netherlands
Completed
Notodden sykehusNotodden, NO-3675, Norway
Completed
Tel Aviv Sourasky Medical CenterTel Aviv, 64239, Israel
Completed
A.O. di Reggio EmiliaReggio Emilia, 42100, Italy
Terminated
Sykehuset Buskerud HFDrammen, NO-3019, Norway
Completed
Wojewodzki Szpital Specjalistyczny im. RydygieraKrakow, 31-826, Poland
Completed
Kungälvs SjukhusKungälv, 442 83, Sweden
Completed
Ziekenhuis Oost-LimburgGENK, 3600, Belgium
Completed
Kreiskrankenhaus RheinfeldenRheinfelden, 79618, Germany
Completed
Wojskowy Instytut MedycznyWarszawa, 00-909, Poland
Completed
Städtische Kliniken Frankfurt am Main / HoechstFrankfurt, 65929, Germany
Terminated
Uniwersytet MedycznyLodz, 91-425, Poland
Completed
Orthopädische Universitätsklinik - FriedrichsheimFrankfurt, 60528, Germany
Completed
Szpital Kliniczny nr 3Gdansk, 80-742, Poland
Terminated
Universitätsklinikum UlmUlm, 89075, Germany
Completed
Klinikum FürthFürth, 90766, Germany
Terminated
Medizinische Einrichtungen der Heinrich-Heine-UniversitätDüsseldorf, 40225, Germany
Completed
Wojewodzki Szpital Specjalistyczny im. S. Wyszynskiego SPZOZLublin, 20-718, Poland
Completed
Donauspital im SMZ-Ost der Stadt WienWien, 1220, Austria
Terminated
CHU Brugmann/UVC BrugmannBRUXELLES - BRUSSEL, 1020, Belgium
Terminated
Herlev HospitalHerlev, 2730, Denmark
Completed
PolyClinique de la providence - PoitiersPOITIERS, 86000, France
Completed
IRCCS Ist Clinico HumanitasRozzano, 20089, Italy
Completed
St. MaartenskliniekNIJMEGEN, 6522 JV, Netherlands
Terminated
Regionaal Ziekenhuis St-TrudoSINT-TRUIDEN, 3800, Belgium
Completed
Medizinische Fakultät Carl Gustav CarusDresden, 01307, Germany
Completed
A.O. Osp Circolo e Fond.MacchiVarese, 21100, Italy
Terminated
Nordlandssykehuset HFBodø, NO-8005, Norway
Completed
IRCCS Fondazione San RaffaeleMilano, 20132, Italy
Terminated
IRCCS Policlinico San MatteoPavia, 27100, Italy
Completed
Sana KlinikenSommerfeld, 16766, Germany

Primary Outcome

  • Composite Endpoint: Any Deep Vein Thrombosis (DVT) (proximal and/or distal) and Non fatal Pulmonary Embolism (PE) and Death from all causes
    date_rangeTime Frame:
    5-9 days after surgery
    enhanced_encryption
    Safety Issue:
    None

Secondary Outcome

  • Incidence of DVTs (total, proximal, distal)
    date_rangeTime Frame:
    5-9 days after surgery
    enhanced_encryption
    Safety Issue:
    None
  • Incidence of symptomatic Venous Thrombo Embolisms (VTEs)
    date_rangeTime Frame:
    5-9 days after surgery
    enhanced_encryption
    Safety Issue:
    None
  • Incidence of symptomatic VTEs (total, PE, DVT) within 30 days after stop of treatment with the study drug
    date_rangeTime Frame:
    40 days
    enhanced_encryption
    Safety Issue:
    None
  • Healthcare Resource Utilisation Questionnaire
    date_rangeTime Frame:
    9 days and 40 days after surgery
    enhanced_encryption
    Safety Issue:
    None

Trial design

Controlled, Double-Blind, Randomised, Dose-ranging Study on the Prevention of VTE in patients Undergoing Elective Total Hip Replacement- ODIXa-HIP2 Study BAY 59-7939
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Prevention
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
6

Additional Information

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