ODiXahip - a Phase IIa Dose Escalating Proof of Principle Trial - Full Text View

Sponsored by:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00839826

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.

Condition	Intervention	Phase
Thromboembolism Prevention	Drug: Rivaroxaban (BAY59-7939) Drug: Enoxaparin	Phase II

MedlinePlus related topics: Blood Thinners Surgery

Drug Information available for: Rivaroxaban Enoxaparin Sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	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

Further study details as provided by Bayer:

Primary Outcome Measures:

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. [ Time Frame: 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Incidence of DVTs (total, proximal, distal) [ Time Frame: will be evaluated 5 - 9 days after surgery. ] [ Designated as safety issue: Yes ]
Incidence of symptomatic VTEs [ Time Frame: 41 days after surgery ] [ Designated as safety issue: Yes ]
The composite endpoint that results from the primary endpoint by using alternative definition of deaths (i.e. VTE related death) [ Time Frame: 41 days after surgery ] [ Designated as safety issue: Yes ]
Incidence of symptomatic VTEs (total, PE, DVT) within 30 days after stop of treatment with the study drug. [ Time Frame: 41 days after surgery ] [ Designated as safety issue: Yes ]

Enrollment:	600
Study Start Date:	December 2002
Study Completion Date:	December 2003
Primary Completion Date:	November 2003 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 2: Active Comparator	Drug: Enoxaparin 40 mg bid
Arm 1: Experimental	Drug: Rivaroxaban (BAY59-7939) 2,5 mg bid,5 mg bid,10mg bid, 20 mg bid, 20 mg tid, 30 mg bid, dose escalation trial

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00839826

Show 41 Study Locations

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

Click here and search for drug information provided by the FDA This link exits the ClinicalTrials.gov site

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product This link exits the ClinicalTrials.gov site

Click here to find results for studies related to marketed products This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Bayer Vital GmbH ( Therapeutic Area Head )
Study ID Numbers:	10942, ODiXaHip
Study First Received:	February 9, 2009
Last Updated:	February 9, 2009
ClinicalTrials.gov Identifier:	NCT00839826 History of Changes
Health Authority:	Sweden: Medical Products Agency; Germany: Federal Institute for Drugs and Medical Devices; Austria: Federal Office for Safety in Health Care; Belgium: Federal Agency for Medicinal Products and Health Products; Denmark: Danish Medicines Agency; France: Afssaps - French Health Products Safety Agency; Netherlands: Medicines Evaluation Board (MEB); Norway: Norwegian Medicines Agency; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Bayer:

Prevention of Thromboembolism after total hip replacement

Study placed in the following topic categories:

Fibrin Modulating Agents
Embolism and Thrombosis
Anticoagulants
Embolism
Vascular Diseases
Fibrinolytic Agents

Cardiovascular Agents
Antithrombin III
Thrombosis
Thromboembolism
Enoxaparin

Additional relevant MeSH terms:

Anticoagulants
Molecular Mechanisms of Pharmacological Action
Hematologic Agents
Vascular Diseases
Fibrinolytic Agents
Cardiovascular Agents
Thromboembolism

Thrombosis
Pharmacologic Actions
Enoxaparin
Embolism and Thrombosis
Fibrin Modulating Agents
Therapeutic Uses
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 06, 2009