Dose-Ranging Study of Once-Daily Regimen of BAY 59-7939 in the Prevention of VTE in Patients Undergoing Elective Total Hip Replacement (ODIXaHIP-OD)

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00396786
First received: November 6, 2006
Last updated: May 7, 2009
Last verified: May 2009
  Purpose

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.


Condition Intervention Phase
Venous Thromboembolism
Drug: Rivaroxaban (Xarelto, BAY59-7939)
Drug: Enoxaparin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Controlled, Double-Blind, Randomized, Dose-Ranging Study of Once-Daily Regimen of BAY59-7939 in the Prevention of VTE in Patients Undergoing Elective Total Hip Replacement- ODIXaHIP-OD

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Composite Endpoint of Deep Vein Thrombosis (DVT), non-fatal Pulmonary Embolism (PE) and Death from all causes [ Time Frame: 6-10 days after surgery ]

Secondary Outcome Measures:
  • Incidence of DVTs (total, proximal, distal) [ Time Frame: 6-10 days after surgery ]
  • Incidence of symptomatic Venous Thrombo Embolisms (VTEs) [ Time Frame: 6-10 days after surgery ]
  • Incidence of major VTE (ie, Proximal DVT, PE or VTE-related death) [ Time Frame: 6-10 days after surgery ]
  • The composite endpoint that results from the primary endpoint by substituting VTE related death for all death [ Time Frame: 40 days ]
  • Incidence of symptomatic VTEs (total, PE, DVT) within 30 days after stop of treatment with the study drug [ Time Frame: 40 days ]

Enrollment: 810
Study Start Date: November 2004
Study Completion Date: July 2005
Arms Assigned Interventions
Experimental: Arm 1 Drug: Rivaroxaban (Xarelto, BAY59-7939)
Rivaroxaban 5 mg once daily plus placebo enoxaparin syringe
Experimental: Arm 2 Drug: Rivaroxaban (Xarelto, BAY59-7939)
Rivaroxaban 10 mg once daily plus placebo enoxaparin syringe
Experimental: Arm 3 Drug: Rivaroxaban (Xarelto, BAY59-7939)
Rivaroxaban 20 mg once daily plus placebo enoxaparin syringe
Experimental: Arm 4 Drug: Rivaroxaban (Xarelto, BAY59-7939)
Rivaroxaban 30 mg once daily plus placebo enoxaparin syringe
Experimental: Arm 5 Drug: Rivaroxaban (Xarelto, BAY59-7939)
Rivaroxaban 40 mg once daily plus placebo enoxaparin syringe
Active Comparator: Arm 6 Drug: Enoxaparin
Enoxaparin 40 mg once daily plus Rivaroxaban placebo tablets

  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:

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 leg

Related 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
  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: NCT00396786

  Show 62 Study Locations
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Therapeutic Area Head, Bayer Healthcare AG
ClinicalTrials.gov Identifier: NCT00396786     History of Changes
Other Study ID Numbers: 11527, EudraCT No: 2004-001341-14
Study First Received: November 6, 2006
Last Updated: May 7, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Bayer:
Prevention of venous thromboembolism

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

ClinicalTrials.gov processed this record on September 30, 2014