check_circleStudy Completed

Venous Thromboembolism

Dose-ranging study of once-daily regimen of BAY 59-7939 in the prevention of VTE in patients undergoing elective total Hip replacement

Trial purpose

The purpose of this study is to assess different doses of a new drug (BAY 59-7939), taken as a tablet, are safe and can help prevent blood clots forming after a hip replacement operation. Patients undergoing hip replacement surgery are at risk of developing blood clots. To reduce this risk treatment to prevent clots forming is routinely given. The current treatments can include injections under the skin or other treatments that need frequent blood tests to monitor levels of drug in the body. Therefore there is a need for new drugs, which are easier to give and need less monitoring.

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
  • - Related to medical history:
     -- 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 legRelated to current symptoms or findings:
     -- Heart insufficiency NYHA class 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 > 200 mmHg, 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- Related to current treatment- 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) should be excluded from the study
     -- Fibrinolytic therapy- Therapy with acetylic salicylic acid or other platelet 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 not allowed during the study treatment period- Systemic and topical treatment with azole compounds (e.g. ketoconazole, fluconazole, itraconazole) and other strong CYP3A4-inhibitors eg HIV-protease inhibitors. Azole compounds and other strong CYP3A4-inhibitors eg HIV-protease should be stopped at least four days before enrolment
    - Therapy with another investigational product within 30 days prior start of study
    - Miscellaneous
    - Planned intermittent pneumatic compression during active treatment period
    - Planned epidural anaesthesia with indwelling epidural catheter (spinal or epidural anaesthesia without indwelling catheter are allowed)
    - If traumatic or repeated epidural and spinal puncture occur the patient should be excluded from study
    - Concomitant participation in another trial or study

Trial summary

Enrollment Goal
877
Trial Dates
November 2004 - July 2005
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
Ziekenhuis Oost-LimburgGENK, 3600, Belgium
Completed
Städtische Kliniken Frankfurt am Main / HoechstFrankfurt, 65929, Germany
Terminated
Kings College HospitalLondon, SE5 9RS, United Kingdom
Completed
Donauspital im SMZ-Ost der Stadt WienWien, 1220, Austria
Completed
Virga Jesse ZiekenhuisHASSELT, 3500, Belgium
Completed
Kreiskrankenhaus RheinfeldenRheinfelden, 79618, Germany
Terminated
Institut Montsouris - ParisPARIS CEDEX 14, 75877, France
Terminated
Ravenscourt Park HospitalLondon, W6 0TN, United Kingdom
Completed
IRCCS Ist Clinico HumanitasRozzano, 20089, Italy
Completed
St. MaartenskliniekNIJMEGEN, 6522 JV, Netherlands
Completed
Wojewodzki Szpital Specjalistyczny im. S. Wyszynskiego SPZOZLublin, 20-718, Poland
Completed
Kungälvs SjukhusKungälv, 442 83, Sweden
Terminated
Clinique les Maussins-Nollet - ParisPARIS CEDEX 19, 75019, France
Completed
IRCCS Fondazione San RaffaeleMilano, 20132, Italy
Completed
Nordsjællands Hospital - HørsholmHørsholm, DK-2970, Denmark
Completed
Hospital Clínico Universitario de ValenciaValencia, 46010, Spain
Terminated
PolyClinique de la providence - PoitiersPOITIERS, 86000, France
Completed
Rambam Medical CenterHaifa, 31096, Israel
Completed
AUSL 1 Perugia - UmbriaGubbio, 06024, Italy
Completed
Tergooiziekenhuizen HilversumHILVERSUM, 1213 XZ, Netherlands
Completed
Helse Blefjell Rjukan sykehusRjukan, NO-3660, Norway
Completed
Samodzielny Publiczny Szpital Kliniczny nr 4Lublin, 20-090, Poland
Completed
SU/ÖstraGöteborg, 416 85, Sweden
Completed
Regionshospitalet SilkeborgSilkeborg, 8600, Denmark
Terminated
Hospital Clínic i Provincial de BarcelonaBarcelona, 08036, Spain
Completed
Assaf Harofeh Medical CenterZerifin, 70300, Israel
Completed
Notodden sykehusNotodden, NO-3675, Norway
Completed
Allgem. öffentl. Krankenhaus Wiener NeustadtWiener Neustadt, 2700, Austria
Completed
ZNA MiddelheimANTWERPEN, 2020, Belgium
Terminated
Klinikum Garmisch-PartenkirchenGarmisch-Partenkirchen, 82467, Germany
Completed
Lovisenberg Diakonale sykehusOslo, 0440, Norway
Completed
LänssjukhusetHalmstad, 301 85, Sweden
Terminated
Imeldaziekenhuis - St-ElisabethkliniekBONHEIDEN, 2820, Belgium
Completed
Sana KlinikenSommerfeld, 16766, Germany
Completed
Länssjukhuset RyhovJönköping, 551 85, Sweden
Completed
Edith Wolfson Medical CenterHolon, 58100, Israel
Completed
A.O. San Gerardo di MonzaMonza, 20052, Italy
Completed
Wojskowy Instytut MedycznyWarszawa, 00-909, Poland
Terminated
Rabin Medical Center, Campus GoldaPetach Tikva, 49372, Israel
Terminated
Istituto Ortopedico G.PiniMilano, 20122, Italy
Completed
Szpital Kliniczny nr 3Gdansk, 80-742, Poland
Completed
Rabin Medical Center - Beilinson CampusPetach Tikva, 49100, Israel
Completed
Medizinische Einrichtungen der Heinrich-Heine-UniversitätDüsseldorf, 40225, Germany
Terminated
Asklepios Klinikum MelsungenMelsungen, 34212, Germany
Completed
Herlev HospitalHerlev, 2730, Denmark
Terminated
Ciutat Sanitària i Universitaria de la Vall d'HebrónBarcelona, 08035, Spain
Terminated
Tel Aviv Sourasky Medical CenterTel Aviv, 64239, Israel
Completed
Spaarne ZiekenhuisHOOFDDORP, 2134 TM, Netherlands
Completed
SP Szpital Kliniczny AM w BialymstokuBialystok, 15-276, Poland
Completed
A.ö. Krankenhaus der Stadt LinzLinz, 4020, Austria
Completed
Gentofte HospitalHellerup, 2900, Denmark
Completed
Hospital Universitari Germans Trias i PujolBadalona, 08916, Spain
Terminated
Polyclinique de l'Atlantique - Saint HerblainSAINT HERBLAIN, 44819, France
Completed
Sapir Medical Center, Meir General HospitalKfar Saba, 44281, Israel
Completed
IRCCS Ist Ortopedico RizzoliBologna, 40136, Italy
Completed
Wojewodzki Szpital Specjalistyczny im. RydygieraKrakow, 31-826, Poland
Completed
Klinikum FürthFürth, 90766, Germany
Completed
Hospital Clínico Universitario San CarlosMadrid, 28040, Spain
Completed
Medizinische Fakultät Carl Gustav CarusDresden, 01307, Germany
Completed
Orthopädische Universitätsklinik - FriedrichsheimFrankfurt, 60528, Germany
Completed
Klinikum der Philipps-UniversitätMarburg, 35043, Germany

Primary Outcome

  • Composite Endpoint of Deep Vein Thrombosis (DVT), non-fatal Pulmonary Embolism (PE) and Death from all causes
    date_rangeTime Frame:
    6-10 days after surgery
    enhanced_encryption
    Safety Issue:
    None

Secondary Outcome

  • Incidence of DVTs (total, proximal, distal)
    date_rangeTime Frame:
    6-10 days after surgery
    enhanced_encryption
    Safety Issue:
    None
  • Incidence of symptomatic Venous Thrombo Embolisms (VTEs)
    date_rangeTime Frame:
    6-10 days after surgery
    enhanced_encryption
    Safety Issue:
    None
  • Incidence of major VTE (ie, Proximal DVT, PE or VTE-related death)
    date_rangeTime Frame:
    6-10 days after surgery
    enhanced_encryption
    Safety Issue:
    None
  • The composite endpoint that results from the primary endpoint by substituting VTE related death for all death
    date_rangeTime Frame:
    40 days
    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

Trial design

Controlled, Double-Blind, Randomized, Dose-ranging Study of once-daily regimen of BAY59-7939 in the Prevention of VTE in patients undergoing Elective total Hip Replacement- ODIXaHIP-OD
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Prevention
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
6