Dose-ranging Study of Once-daily Regimen of BAY 59-7939 in the Prevention of VTE in Patients Undergoing Elective Total Hip Replacement

NCT ID: NCT00396786

Last Updated: 2014-10-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 877 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-11-30
• Study Completion Date: 2005-07-31

Brief Summary

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.

Conditions

Venous Thromboembolism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Arm 1

Group Type: EXPERIMENTAL

Rivaroxaban (Xarelto, BAY59-7939)

Intervention Type: DRUG

Rivaroxaban 5 mg once daily plus placebo enoxaparin syringe

Arm 2

Group Type: EXPERIMENTAL

Rivaroxaban (Xarelto, BAY59-7939)

Intervention Type: DRUG

Rivaroxaban 10 mg once daily plus placebo enoxaparin syringe

Arm 3

Group Type: EXPERIMENTAL

Rivaroxaban (Xarelto, BAY59-7939)

Intervention Type: DRUG

Rivaroxaban 20 mg once daily plus placebo enoxaparin syringe

Arm 4

Group Type: EXPERIMENTAL

Rivaroxaban (Xarelto, BAY59-7939)

Intervention Type: DRUG

Rivaroxaban 30 mg once daily plus placebo enoxaparin syringe

Arm 5

Group Type: EXPERIMENTAL

Rivaroxaban (Xarelto, BAY59-7939)

Intervention Type: DRUG

Rivaroxaban 40 mg once daily plus placebo enoxaparin syringe

Arm 6

Group Type: ACTIVE_COMPARATOR

Enoxaparin

Intervention Type: DRUG

Enoxaparin 40 mg once daily plus Rivaroxaban placebo tablets

Interventions

Rivaroxaban (Xarelto, BAY59-7939)

Rivaroxaban 5 mg once daily plus placebo enoxaparin syringe

Intervention Type: DRUG

Rivaroxaban (Xarelto, BAY59-7939)

Rivaroxaban 10 mg once daily plus placebo enoxaparin syringe

Intervention Type: DRUG

Rivaroxaban (Xarelto, BAY59-7939)

Rivaroxaban 20 mg once daily plus placebo enoxaparin syringe

Intervention Type: DRUG

Rivaroxaban (Xarelto, BAY59-7939)

Rivaroxaban 30 mg once daily plus placebo enoxaparin syringe

Intervention Type: DRUG

Rivaroxaban (Xarelto, BAY59-7939)

Rivaroxaban 40 mg once daily plus placebo enoxaparin syringe

Intervention Type: DRUG

Enoxaparin

Enoxaparin 40 mg once daily plus Rivaroxaban placebo tablets

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)

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

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

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Bayer Healthcare AG

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Wiener Neustadt, Lower Austria, Austria

Linz, Upper Austria, Austria

Linz, Upper Austria, Austria

Vienna, Vienna, Austria

Antwerp, , Belgium

Bonheiden, , Belgium

Genk, , Belgium

Hasselt, , Belgium

Hellerup, , Denmark

Herlev, , Denmark

Hørsholm, , Denmark

Silkeborg, , Denmark

Paris, , France

Paris, , France

Poitiers, , France

Saint-Herblain, , France

Rheinfelden, Baden-Wurttemberg, Germany

Fürth, Bavaria, Germany

Garmisch-Partenkirchen, Bavaria, Germany

Sommerfeld, Brandenburg, Germany

Frankfurt am Main, Hesse, Germany

Frankfurt am Main, Hesse, Germany

Marburg, Hesse, Germany

Melsungen, Hesse, Germany

Düsseldorf, North Rhine-Westphalia, Germany

Dresden, Saxony, Germany

Petah Tikva, Isarel, Israel

Haifa, Israel, Israel

Holon, Israel, Israel

Kfar Saba, Israel, Israel

Petah Tikva, Israel, Israel

Tel Aviv, Israel, Israel

Ẕerifin, Israel, Israel

Monza, Milano, Italy

Rozzano, Milano, Italy

Gubbio, Perugia, Italy

Bologna, , Italy

Milan, , Italy

Milan, , Italy

Hilversum, , Netherlands

Hoofddorp, , Netherlands

Nijmegen, , Netherlands

Notodden, , Norway

Oslo, , Norway

Rjukan, , Norway

Bialystok, , Poland

Gdansk, , Poland

Krakow, , Poland

Lublin, , Poland

Lublin, , Poland

Warsaw, , Poland

Badalona, Barcelona, Spain

Barcelona, Barcelona, Spain

Barcelona, Barcelona, Spain

Madrid, Madrid, Spain

Valencia, Valencia, Spain

Gothenburg, , Sweden

Halmstad, , Sweden

Jönköping, , Sweden

Kungälv, , Sweden

London, Greater London, United Kingdom

London, Greater London, United Kingdom

Countries

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

Related Links

http://www.clinicaltrialsregister.eu

Click here and search for information of Bayer products for Europe

Other Identifiers

EudraCT No: 2004-001341-14

Identifier Type: -

Identifier Source: secondary_id

11527

Identifier Type: -

Identifier Source: org_study_id