ODiXahip - a Phase IIa Dose Escalating Proof of Principle Trial

NCT ID: NCT00839826

Last Updated: 2014-12-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 641 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-12-31
• Study Completion Date: 2003-11-30

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.

Conditions

Thromboembolism; Prevention

Keywords

Prevention of Thromboembolism after total hip replacement

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Arm 2

Group Type: ACTIVE_COMPARATOR

Enoxaparin

Intervention Type: DRUG

40 mg bid

Arm 1

Group Type: EXPERIMENTAL

Rivaroxaban (BAY59-7939)

Intervention Type: DRUG

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

Interventions

Rivaroxaban (BAY59-7939)

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

Intervention Type: DRUG

Enoxaparin

40 mg bid

Intervention Type: DRUG

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Wiener Neustadt, Lower Austria, Austria

Linz, Upper Austria, Austria

Vienna, Vienna, Austria

Baudour, , Belgium

Brussels, , Belgium

Ghent, , Belgium

Huy, , Belgium

Hellerup, , Denmark

Herlev, , Denmark

Hørsholm, , Denmark

Silkeborg, , Denmark

Amiens, , France

Lille, , France

Nancy, , France

Rheinfelden, Baden-Wurttemberg, Germany

Fürth, Bavaria, Germany

Garmisch-Partenkirchen, Bavaria, Germany

Frankfurt am Main, Hesse, Germany

Frankfurt am Main, Hesse, Germany

Dresden, Saxony, Germany

Berlin, State of Berlin, Germany

Haifa, Israel, Israel

Tel Aviv, , Israel

Tel Litwinsky, , Israel

Ẕerifin, , Israel

Amersfoort, , Netherlands

Zwolle, , Netherlands

Notodden, , Norway

Oslo, , Norway

Rjukan, , Norway

Bialystok, , Poland

Gdansk, , Poland

Krakow, , Poland

Lodz, , Poland

Lublin, , Poland

Lublin, , Poland

Warsaw, , Poland

Gothenburg, , Sweden

Jönköping, , Sweden

Kungälv, , Sweden

London, Greater London, United Kingdom

Countries

Austria; Belgium; Denmark; France; Germany; Israel; Netherlands; Norway; Poland; Sweden; United Kingdom

Other Identifiers

10942

Identifier Type: -

Identifier Source: org_study_id