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ODiXahip - a Phase IIa Dose Escalating Proof of Principle Trial (ODiXaHip)

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00839826
First received: February 9, 2009
Last updated: June 19, 2009
Last verified: June 2009
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:


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
Active Comparator: Arm 2 Drug: Enoxaparin
40 mg bid
Experimental: Arm 1 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
No publications provided

Responsible Party: Head Clinical Pharmacology, Bayer Vital GmbH
ClinicalTrials.gov Identifier: NCT00839826     History of Changes
Other Study ID Numbers: 10942
Study First Received: February 9, 2009
Last Updated: June 19, 2009
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 - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
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

Additional relevant MeSH terms:
Thromboembolism
Cardiovascular Diseases
Embolism and Thrombosis
Thrombosis
Vascular Diseases
Rivaroxaban
Anticoagulants
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014