Trial Condition(s):
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 (ODIXaHIP-OD)
Bayer Identifier:
11527
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
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.
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Krankenhaus der Barmherzigen Schwestern Linz Linz, Austria, 4010 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ziekenhuis Oost-Limburg GENK, Belgium, 3600 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Städtische Kliniken Frankfurt am Main / Hoechst Frankfurt, Germany, 65929 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kings College Hospital London, United Kingdom, SE5 9RS | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Donauspital im SMZ-Ost der Stadt Wien Wien, Austria, 1220 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Virga Jesse Ziekenhuis HASSELT, Belgium, 3500 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kreiskrankenhaus Rheinfelden Rheinfelden, Germany, 79618 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Institut Montsouris - Paris PARIS CEDEX 14, France, 75877 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ravenscourt Park Hospital London, United Kingdom, W6 0TN | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations IRCCS Ist Clinico Humanitas Rozzano, Italy, 20089 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations St. Maartenskliniek NIJMEGEN, Netherlands, 6522 JV | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Wojewodzki Szpital Specjalistyczny im. S. Wyszynskiego SPZOZ Lublin, Poland, 20-718 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kungälvs Sjukhus Kungälv, Sweden, 442 83 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clinique les Maussins-Nollet - Paris PARIS CEDEX 19, France, 75019 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations IRCCS Fondazione San Raffaele Milano, Italy, 20132 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Nordsjællands Hospital - Hørsholm Hørsholm, Denmark, DK-2970 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Clínico Universitario de Valencia Valencia, Spain, 46010 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations PolyClinique de la providence - Poitiers POITIERS, France, 86000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Rambam Medical Center Haifa, Israel, 31096 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations AUSL 1 Perugia - Umbria Gubbio, Italy, 06024 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Tergooiziekenhuizen Hilversum HILVERSUM, Netherlands, 1213 XZ | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Helse Blefjell Rjukan sykehus Rjukan, Norway, NO-3660 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Samodzielny Publiczny Szpital Kliniczny nr 4 Lublin, Poland, 20-090 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations SU/Östra Göteborg, Sweden, 416 85 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Regionshospitalet Silkeborg Silkeborg, Denmark, 8600 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Clínic i Provincial de Barcelona Barcelona, Spain, 08036 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Assaf Harofeh Medical Center Zerifin, Israel, 70300 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Notodden sykehus Notodden, Norway, NO-3675 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Allgem. öffentl. Krankenhaus Wiener Neustadt Wiener Neustadt, Austria, 2700 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations ZNA Middelheim ANTWERPEN, Belgium, 2020 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinikum Garmisch-Partenkirchen Garmisch-Partenkirchen, Germany, 82467 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Lovisenberg Diakonale sykehus Oslo, Norway, 0440 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Länssjukhuset Halmstad, Sweden, 301 85 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Imeldaziekenhuis - St-Elisabethkliniek BONHEIDEN, Belgium, 2820 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Sana Kliniken Sommerfeld, Germany, 16766 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Länssjukhuset Ryhov Jönköping, Sweden, 551 85 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Edith Wolfson Medical Center Holon, Israel, 58100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O. San Gerardo di Monza Monza, Italy, 20052 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Wojskowy Instytut Medyczny Warszawa, Poland, 00-909 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Rabin Medical Center, Campus Golda Petach Tikva, Israel, 49372 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Istituto Ortopedico G.Pini Milano, Italy, 20122 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Szpital Kliniczny nr 3 Gdansk, Poland, 80-742 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Rabin Medical Center - Beilinson Campus Petach Tikva, Israel, 49100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Medizinische Einrichtungen der Heinrich-Heine-Universität Düsseldorf, Germany, 40225 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Asklepios Klinikum Melsungen Melsungen, Germany, 34212 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Herlev Hospital Herlev, Denmark, 2730 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ciutat Sanitària i Universitaria de la Vall d'Hebrón Barcelona, Spain, 08035 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Tel Aviv Sourasky Medical Center Tel Aviv, Israel, 64239 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Spaarne Ziekenhuis HOOFDDORP, Netherlands, 2134 TM | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations SP Szpital Kliniczny AM w Bialymstoku Bialystok, Poland, 15-276 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.ö. Krankenhaus der Stadt Linz Linz, Austria, 4020 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Gentofte Hospital Hellerup, Denmark, 2900 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Universitari Germans Trias i Pujol Badalona, Spain, 08916 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Polyclinique de l'Atlantique - Saint Herblain SAINT HERBLAIN, France, 44819 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Sapir Medical Center, Meir General Hospital Kfar Saba, Israel, 44281 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations IRCCS Ist Ortopedico Rizzoli Bologna, Italy, 40136 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Wojewodzki Szpital Specjalistyczny im. Rydygiera Krakow, Poland, 31-826 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinikum Fürth Fürth, Germany, 90766 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Clínico Universitario San Carlos Madrid, Spain, 28040 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Medizinische Fakultät Carl Gustav Carus Dresden, Germany, 01307 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Orthopädische Universitätsklinik - Friedrichsheim Frankfurt, Germany, 60528 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinikum der Philipps-Universität Marburg, Germany, 35043 | Contact Us: E-mail: [email protected] Phone: Not Available |
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
Primary Outcome
- Composite Endpoint of Deep Vein Thrombosis (DVT), non-fatal Pulmonary Embolism (PE) and Death from all causesTimeframe: 6-10 days after surgery
Secondary Outcome
- Incidence of DVTs (total, proximal, distal)Timeframe: 6-10 days after surgery
- Incidence of symptomatic Venous Thrombo Embolisms (VTEs)Timeframe: 6-10 days after surgery
- Incidence of major VTE (ie, Proximal DVT, PE or VTE-related death)Timeframe: 6-10 days after surgery
- The composite endpoint that results from the primary endpoint by substituting VTE related death for all deathTimeframe: 40 days
- Incidence of symptomatic VTEs (total, PE, DVT) within 30 days after stop of treatment with the study drugTimeframe: 40 days
Additional Information
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