An Oral, Direct Factor Xa Inhibitor, BAY59-7939, for Prophylaxis Against Venous Thromboembolism After Total Knee Replacement: a Dose-Ranging Study

December 18, 2014 updated by: Bayer
The study drug, BAY59-7939, is a new drug currently being tested in the prevention of VTE. It directly inhibits factor Xa, a blood component in the pathway which leads to coagulation (clotting of blood cells). It is available as a tablet. The purpose of this study is to compare the safety and efficacy of BAY59-7939 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. In this study 4 different doses of the investigational drug BAY59-7939 will be tested in comparison to Enoxaparin. You will receive during the study either one of the following BAY59-7939 treatments or Enoxaparin. The following doses of BAY59-7939 will be tested: Dose I ; Dose II, Dose III, Dose IV. This study will run for approximately 7 months in a number of countries. In total, up to 600 patients may participate in this study.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
613

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
      • Red Deer, Alberta, Canada, T4N 4E7
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 1T2
      • Vancouver, British Columbia, Canada, V6Z 1Y6
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1M3
    • New Brunswick
      • Fredericton, New Brunswick, Canada, E3B 5N5
    • Ontario
      • Barrie, Ontario, Canada, L4M 6M2
      • Kitchener, Ontario, Canada, N2G 1G3
      • Niagara Falls, Ontario, Canada, L2G 5X8
      • Oshawa, Ontario, Canada, L1G 2B9
      • Ottawa, Ontario, Canada, K1H 8L6
      • Peterborough, Ontario, Canada, K9J 7H8
      • Richmond Hill, Ontario, Canada, L4C 4Z3
      • St. Catharines, Ontario, Canada, L2R 5K3
      • Sudbury, Ontario, Canada, P3E 6C3
      • Thunder Bay, Ontario, Canada, P7B 6V4
      • Toronto, Ontario, Canada, M3M 2G2
      • Welland, Ontario, Canada, L3B 4W6
    • Prince Edward Island
      • Charlottetown, Prince Edward Island, Canada, C1A 1L2
    • Quebec
      • Montreal, Quebec, Canada, H3G 1A4
      • Quebec City, Quebec, Canada, G1J 1Z4
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
    • Arizona
      • Phoenix, Arizona, United States, 85023
      • Tucson, Arizona, United States, 85712
    • California
      • La Mesa, California, United States, 91942-3019
      • Torrance, California, United States, 90502-2004
    • Colorado
      • Aurora, Colorado, United States, 80012
      • Aurora, Colorado, United States, 80011-6798
    • Florida
      • Jacksonville, Florida, United States, 32216
      • Palm Beach Gardens, Florida, United States, 33410
      • Sarasota, Florida, United States, 34239
      • St. Petersburg, Florida, United States, 33703
    • Georgia
      • Decatur, Georgia, United States, 30033
    • Ohio
      • Cincinnati, Ohio, United States, 45219
    • Texas
      • Dallas, Texas, United States, 75231
      • Lubbock, Texas, United States, 79410

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male subjects aged 18 years or above and postmenopausal female subjects
  • Subjects scheduled for elective total knee replacement
  • Subjects written informed consent for participation after receiving detailed written and oral information previous to any study specific procedures

Exclusion Criteria:

Related to medical history:

  • Any prior DVT or PE
  • Myocardial infarction (MI), TIA or ischaemic stroke within the last 6 months prior to randomization
  • History of heparin-induced thrombocytopenia, allergy to heparins
  • Intracerebral or intraocular bleeding within the last 6 months prior to randomization
  • History of gastrointestinal disease (e.g. active peptic ulcer) with gastrointestinal bleeding within the last 6 months prior to randomization
  • 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 III-IV

  • Congenital or acquired haemorrhagic diathesis (PT INR/aPTT not within normal limits)including patients with acquired or congenital thrombophilia

    • Thrombocytopenia (platelets < 100,000/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 or decreased creatinine clearance < 30ml/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:

  • Therapy with oral anticoagulants (e.g. phenprocoumon, warfarin-sodium, heparins and factor Xa inhibitors other than study medication) and fibrinolytic therapy
  • Therapy with acetylic salicylic acid or other thrombocyte aggregation inhibitors (e.g. clopidogrel, dipyridamole and ticlopidine) should be stopped one week before enrollment. Patient not able to stop ASA therapy will be excluded
  • All other drugs influencing coagulation, (exception: NSAIDs with half life < 17 hrs will be allowed)
  • Systemic and topical treatment with azole compounds (e.g. ketoconazole, fluconazole, itraconazole). Azole compounds should be stopped at least four days before enrollment

Miscellaneous:

  • Planned intermittent pneumatic compression during active treatment period
  • Planned epidural anaesthesia with indwelling epidural catheter (spinal and epidural anaesthesia without indwelling catheter is allowed)
  • Therapy with another investigational product within 30 days prior to the start of the study
  • Concomitant participation in another trial or study

Removal of Subjects from Study:

A subject who withdraws is one who discontinued a clinical study for any reason.

Subjects may be withdrawn from the study for the following reasons:

  • At their own request or at the request of their legally acceptable representative
  • If, in the investigator's opinion, continuation in the study would be detrimental to the subject's well-being
  • At the specific request of the sponsor

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Arm 1
Drug: Rivaroxaban (BAY59-7939)
2.5mg bid
Experimental: Arm 2
Drug: Rivaroxaban, (BAY59-7939)
5mg bid
Drug: Rivaroxaban, (BAY59-7939)
10 mg bid
Drug: Rivaroxaban, (BAY59-7939)
20mg bid
Experimental: Arm 3
Drug: Rivaroxaban, (BAY59-7939)
5mg bid
Drug: Rivaroxaban, (BAY59-7939)
10 mg bid
Drug: Rivaroxaban, (BAY59-7939)
20mg bid
Experimental: Arm 4
Drug: Rivaroxaban, (BAY59-7939)
5mg bid
Drug: Rivaroxaban, (BAY59-7939)
10 mg bid
Drug: Rivaroxaban, (BAY59-7939)
20mg bid
Experimental: Arm 5
Drug: Enoxaparine
30mg bid
Experimental: Arm 6
Drug: Enoxaparine
30mg bid

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Composite endpoints of Deep vein Thrombosis (proximal and/or distal),non fatal PE and death from all causes
Time Frame: 5-9 days after surgery or earlier in case of symptoms indicating deep vein Thrombosis.
5-9 days after surgery or earlier in case of symptoms indicating deep vein Thrombosis.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Incidence of DVTs (total, proximal, distal)
Time Frame: Day 6-10
Day 6-10
Incidence of symptomatic VTEs
Time Frame: Day 6-10
Day 6-10
The composite endpoint that results from the primary endpoint by substituting VTE related death for all deaths
Time Frame: Day 6-10
Day 6-10
Incidence of symptomatic VTEs (total, PE, DVT)
Time Frame: Day 6-10
Day 6-10

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2004

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2004

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2004

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 21, 2006

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 21, 2006

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 22, 2006

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 23, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 18, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 10945

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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