Trial Condition(s):
Thromboembolism, Prevention
ODiXahip - a Phase IIa Dose Escalating Proof of Principle Trial (ODiXaHip)
Bayer Identifier:
10942
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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.
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
- 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). - 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 -- Therapy with oral anticoagulants (e.g. phenprocoumon, warfarin-sodium). -- Therapy with acetylic salicylic acid or other thrombocyte aggregation inhibitors (e.g. clopidogrel, dipyridamole and ticlopidine) should be stopped one week before enrolment -- Treatment with heparins or Factor Xa Inhibitors other than study medication. -- All other drugs influencing coagulation, (exception: NSAIDs with half life < 17 hrs will be allowed).
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Städtische Kliniken Frankfurt am Main / Hoechst Frankfurt, Germany, 65929 | 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 Isala Klinieken, Locatie Sophia ZWOLLE, Netherlands, 8025 AB | 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 Hopital Roger Salengro - Lille LILLE CEDEX, France, 59037 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Meander Medisch Centrum/Locatie De Lichtenberg AMERSFOORT, Netherlands, 3818 ES | 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 Donauspital im SMZ-Ost der Stadt Wien Wien, Austria, 1220 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations UZ Brussel BRUXELLES, Belgium, 1090 | 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 Lovisenberg Diakonale sykehus Oslo, Norway, 0440 | 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 Gentofte Hospital Hellerup, Denmark, 2900 | 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 Chaim Sheba Medical Center Tel Hashomer, Israel, 52621 | 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 Allgem. öffentl. Krankenhaus Wiener Neustadt Wiener Neustadt, Austria, 2700 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations RHMS Site Louis Caty BAUDOUR, Belgium, 7331 | 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 Kings College Hospital London, United Kingdom, SE5 9RS | 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 Krankenhaus der Barmherzigen Schwestern Linz Linz, Austria, 4010 | 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 Wojewodzki Szpital Specjalistyczny im. S. Wyszynskiego SPZOZ Lublin, Poland, 20-718 | 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 Hôpital Nord - Amiens AMIENS, France, 80030 | 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 UZ Gent GENT, Belgium, 9000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hopital Central - Nancy NANCY, France, 54037 | 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 Klinikum Fürth Fürth, Germany, 90766 | 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 Medizinische Fakultät Carl Gustav Carus Dresden, Germany, 01307 | 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 CHR de Huy HUY, Belgium, 4500 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Uniwersytet Medyczny Lodz, Poland, 91-425 | 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 Szpital Kliniczny nr 3 Gdansk, Poland, 80-742 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Helios Klinikum Emil von Behring Berlin, Germany, 14165 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Oral Direct Factor Xa Inhibitor BAY 59-7939 in the Prevention of VTE in Patients Undergoing Total Hip Replacement. ODiXahip - a Phase IIa Dose Escalating Proof of Principle Trial
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Prevention
Allocation:
Randomized
Blinding:
Open Label
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- 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.Timeframe: 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 Outcome
- Incidence of DVTs (total, proximal, distal)Timeframe: will be evaluated 5 - 9 days after surgery.
- Incidence of symptomatic VTEsTimeframe: 41 days after surgery
- The composite endpoint that results from the primary endpoint by using alternative definition of deaths (i.e. VTE related death)Timeframe: 41 days after surgery
- Incidence of symptomatic VTEs (total, PE, DVT) within 30 days after stop of treatment with the study drug.Timeframe: 41 days after surgery
Additional Information
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