AzTrials
AzTrials

Venous ThromboembolismPhase 2NCT00402467

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

A Phase 2 study testing Rivaroxaban (BAY59-7939), Rivaroxaban, (BAY59-7939) and Enoxaparine in people with Venous Thromboembolism, run by Bayer at 36 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Venous Thromboembolism
What is being tested?
Rivaroxaban (BAY59-7939), Rivaroxaban, (BAY59-7939) and Enoxaparine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
613 participants
Where
36 sitesin 2 countries
Study dates
Feb 2004to Nov 2004
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 37Show fewer
  • 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

Trial locations and contacts

36 sites in 2 countries.

36 sites in 2 countries

Canada21 sites

  • Study site

    Barrie, Ontario, L4M 6M2

  • Study site

    Charlottetown, Prince Edward Island, C1A 1L2

  • Study site

    Edmonton, Alberta, T6G 2B7

  • Study site

    Fredericton, New Brunswick, E3B 5N5

  • Study site

    Greater Sudbury, Ontario, P3E 6C3

  • Study site

    Kelowna, British Columbia, V1Y 1T2

  • Study site

    Kitchener, Ontario, N2G 1G3

  • Study site

    Montreal, Quebec, H3G 1A4

  • Study site

    Niagara Falls, Ontario, L2G 5X8

  • Study site

    Oshawa, Ontario, L1G 2B9

  • Study site

    Ottawa, Ontario, K1H 8L6

  • Study site

    Peterborough, Ontario, K9J 7H8

  • Study site

    Québec, Quebec, G1J 1Z4

  • Study site

    Red Deer, Alberta, T4N 4E7

  • Study site

    Richmond Hill, Ontario, L4C 4Z3

  • Study site

    St. Catharines, Ontario, L2R 5K3

  • Study site

    Thunder Bay, Ontario, P7B 6V4

  • Study site

    Toronto, Ontario, M3M 2G2

  • Study site

    Vancouver, British Columbia, V6Z 1Y6

  • Study site

    Welland, Ontario, L3B 4W6

  • Study site

    Winnipeg, Manitoba, R3A 1M3

Other trials in Canada

United States15 sites

  • Study site

    Aurora, Colorado, 80011-6798

  • Study site

    Aurora, Colorado, 80012

  • Study site

    Birmingham, Alabama, 35205

  • Study site

    Cincinnati, Ohio, 45219

  • Study site

    Dallas, Texas, 75231

  • Study site

    Decatur, Georgia, 30033

  • Study site

    Jacksonville, Florida, 32216

  • Study site

    La Mesa, California, 91942-3019

  • Study site

    Lubbock, Texas, 79410

  • Study site

    Palm Beach Gardens, Florida, 33410

  • Study site

    Phoenix, Arizona, 85023

  • Study site

    Sarasota, Florida, 34239

  • Study site

    St. Petersburg, Florida, 33703

  • Study site

    Torrance, California, 90502-2004

  • Study site

    Tucson, Arizona, 85712

Other trials in United States

About this study

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.

Being tested
Rivaroxaban (BAY59-7939), Rivaroxaban, (BAY59-7939), Enoxaparine
Keywords
Prevention of venous thromboembolism
Medical subject headings
Venous Thromboembolism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Rivaroxaban (BAY59-7939)Drug

    2.5mg bid

  • Rivaroxaban, (BAY59-7939)Drug

    5mg bid

  • Rivaroxaban, (BAY59-7939)Drug

    10 mg bid

  • Rivaroxaban, (BAY59-7939)Drug

    20mg bid

  • EnoxaparineDrug

    30mg bid

  • EnoxaparineDrug

    30mg bid

Study groups in NCT00402467
Study groupRoleWhat they receive
Arm 6ExperimentalNot described
Receives: Drug: Enoxaparine
Arm 1ExperimentalNot described
Receives: Drug: Rivaroxaban (BAY59-7939)
Arm 2ExperimentalNot described
Receives: Drug: Rivaroxaban, (BAY59-7939)
Arm 3ExperimentalNot described
Receives: Drug: Rivaroxaban, (BAY59-7939)
Arm 4ExperimentalNot described
Receives: Drug: Rivaroxaban, (BAY59-7939)
Arm 5ExperimentalNot described
Receives: Drug: Enoxaparine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Composite endpoints of Deep vein Thrombosis (proximal and/or distal),non fatal PE and death from all causes

    Measured: 5-9 days after surgery or earlier in case of symptoms indicating deep vein Thrombosis.

Secondary outcomes (4)

  1. Incidence of DVTs (total, proximal, distal)

    Measured: Day 6-10

  2. Incidence of symptomatic VTEs

    Measured: Day 6-10

  3. The composite endpoint that results from the primary endpoint by substituting VTE related death for all deaths

    Measured: Day 6-10

  4. Incidence of symptomatic VTEs (total, PE, DVT)

    Measured: Day 6-10

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Nov 2006 (estimated)
  2. Study startFeb 2004
  3. Primary completionNov 2004
  4. Study completionNov 2004

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
613 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00402467
Sponsor's protocol ID
10945
Status last verified
Dec 2014
First submitted
21 Nov 2006
Last updated
23 Dec 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Rivaroxaban (BAY59-7939), Rivaroxaban, (BAY59-7939) and Enoxaparine in people with Venous Thromboembolism, run by Bayer at 36 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 sites in Canada, United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00402467.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2014.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in