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Venous ThromboembolismPhase 2ODIXaHIP-ODNCT00396786

Dose-ranging Study of Once-daily Regimen of BAY 59-7939 in the Prevention of VTE in Patients Undergoing Elective Total Hip Replacement

A Phase 2 study testing Rivaroxaban (Xarelto, BAY59-7939) and Enoxaparin in people with Venous Thromboembolism, run by Bayer at 62 sites in 13 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 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. 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 (Xarelto, BAY59-7939) and Enoxaparin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
877 participants
Where
62 sitesin 13 countries
Study dates
Nov 2004to Jul 2005
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 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
Show all 23Show fewer
  • 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 legRelated 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

Who cannot join

None listed.

Trial locations and contacts

62 sites in 13 countries.

62 sites in 13 countries

Germany10 sites

  • Study site

    Dresden, Saxony, 01307

  • Study site

    Düsseldorf, North Rhine-Westphalia, 40225

  • Study site

    Frankfurt am Main, Hesse, 60528

  • Study site

    Frankfurt am Main, Hesse, 65929

  • Study site

    Fürth, Bavaria, 90766

  • Study site

    Garmisch-Partenkirchen, Bavaria, 82467

  • Study site

    Marburg, Hesse, 35043

  • Study site

    Melsungen, Hesse, 34212

  • Study site

    Rheinfelden, Baden-Wurttemberg, 79618

  • Study site

    Sommerfeld, Brandenburg, 16766

Other trials in Germany

Israel7 sites

  • Study site

    Haifa, Israel, 31096

  • Study site

    Holon, Israel, 58100

  • Study site

    Kfar Saba, Israel, 44281

  • Study site

    Petah Tikva, Isarel, 49372

  • Study site

    Petah Tikva, Israel, 49100

  • Study site

    Tel Aviv, Israel, 64239

  • Study site

    Tsrifin, Israel, 70300

Other trials in Israel

Italy6 sites

  • Study site

    Bologna, 40136

  • Study site

    Gubbio, Perugia, 06024

  • Study site

    Milan, 20122

  • Study site

    Milan, 20132

  • Study site

    Monza, Milano, 20052

  • Study site

    Rozzano, Milano, 20089

Other trials in Italy

Poland6 sites

  • Study site

    Bialystok, 15-276

  • Study site

    Gdansk, 80-742

  • Study site

    Krakow, 31-826

  • Study site

    Lublin, 20-090

  • Study site

    Lublin, 20-718

  • Study site

    Warsaw, 00-909

Other trials in Poland

Spain5 sites

  • Study site

    Badalona, Barcelona, 08916

  • Study site

    Barcelona, Barcelona, 08035

  • Study site

    Barcelona, Barcelona, 08036

  • Study site

    Madrid, Madrid, 28040

  • Study site

    Valencia, Valencia, 46010

Other trials in Spain

Austria4 sites

  • Study site

    Linz, Upper Austria, 4010

  • Study site

    Linz, Upper Austria, 4020

  • Study site

    Vienna, State of Vienna, 1220

  • Study site

    Wiener Neustadt, Lower Austria, 2700

Other trials in Austria

Belgium4 sites

  • Study site

    Antwerp, 2020

  • Study site

    Bonheiden, 2820

  • Study site

    Genk, 3600

  • Study site

    Hasselt, 3500

Other trials in Belgium

Denmark4 sites

  • Study site

    Hellerup, 2900

  • Study site

    Herlev, 2730

  • Study site

    Hørsholm, DK-2970

  • Study site

    Silkeborg, 8600

Other trials in Denmark

France4 sites

  • Study site

    Paris, 75019

  • Study site

    Paris, 75877

  • Study site

    Poitiers, 86000

  • Study site

    Saint-Herblain, 44819

Other trials in France

Sweden4 sites

  • Study site

    Gothenburg, 416 85

  • Study site

    Halmstad, 301 85

  • Study site

    Jönköping, 551 85

  • Study site

    Kungälv, 442 83

Other trials in Sweden

Netherlands3 sites

  • Study site

    Hilversum, 1213 XZ

  • Study site

    Hoofddorp, 2134 TM

  • Study site

    Nijmegen, 6522 JV

Other trials in Netherlands

Norway3 sites

  • Study site

    Notodden, NO-3675

  • Study site

    Oslo, 0440

  • Study site

    Rjukan, NO-3660

Other trials in Norway

United Kingdom2 sites

  • Study site

    London, Greater London, SE5 9RS

  • Study site

    London, Greater London, W6 0TN

Other trials in United Kingdom

About this study

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

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.

Being tested
Rivaroxaban (Xarelto, BAY59-7939), Enoxaparin
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 (Xarelto, BAY59-7939)Drug

    Rivaroxaban 5 mg once daily plus placebo enoxaparin syringe

  • Rivaroxaban (Xarelto, BAY59-7939)Drug

    Rivaroxaban 10 mg once daily plus placebo enoxaparin syringe

  • Rivaroxaban (Xarelto, BAY59-7939)Drug

    Rivaroxaban 20 mg once daily plus placebo enoxaparin syringe

  • Rivaroxaban (Xarelto, BAY59-7939)Drug

    Rivaroxaban 30 mg once daily plus placebo enoxaparin syringe

  • Rivaroxaban (Xarelto, BAY59-7939)Drug

    Rivaroxaban 40 mg once daily plus placebo enoxaparin syringe

  • EnoxaparinDrug

    Enoxaparin 40 mg once daily plus Rivaroxaban placebo tablets

Study groups in NCT00396786
Study groupRoleWhat they receive
Arm 1ExperimentalNot described
Receives: Drug: Rivaroxaban (Xarelto, BAY59-7939)
Arm 2ExperimentalNot described
Receives: Drug: Rivaroxaban (Xarelto, BAY59-7939)
Arm 3ExperimentalNot described
Receives: Drug: Rivaroxaban (Xarelto, BAY59-7939)
Arm 4ExperimentalNot described
Receives: Drug: Rivaroxaban (Xarelto, BAY59-7939)
Arm 5ExperimentalNot described
Receives: Drug: Rivaroxaban (Xarelto, BAY59-7939)
Arm 6Active comparatorNot described
Receives: Drug: Enoxaparin

What is being measured

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

  1. Composite Endpoint of Deep Vein Thrombosis (DVT), non-fatal Pulmonary Embolism (PE) and Death from all causes

    Measured: 6-10 days after surgery

Secondary outcomes (5)

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

    Measured: 6-10 days after surgery

  2. Incidence of symptomatic Venous Thrombo Embolisms (VTEs)

    Measured: 6-10 days after surgery

  3. Incidence of major VTE (ie, Proximal DVT, PE or VTE-related death)

    Measured: 6-10 days after surgery

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

    Measured: 40 days

  5. Incidence of symptomatic VTEs (total, PE, DVT) within 30 days after stop of treatment with the study drug

    Measured: 40 days

Timeline

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

  1. First posted7 Nov 2006 (estimated)
  2. Study startNov 2004
  3. Primary completionJul 2005
  4. Study completionJul 2005

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
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
877 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00396786
Sponsor's protocol ID
11527
Other IDs
EudraCT No: 2004-001341-14
Acronym
ODIXaHIP-OD
Status last verified
Oct 2014
First submitted
6 Nov 2006
Last updated
28 Oct 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Rivaroxaban (Xarelto, BAY59-7939) and Enoxaparin in people with Venous Thromboembolism, run by Bayer at 62 sites in 13 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 23 inclusion and 0 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 28 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 62 sites in Germany, Israel, Italy, Poland, Spain and 8 more countries. 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 Endpoint of Deep Vein Thrombosis (DVT), non-fatal Pulmonary Embolism (PE) and Death from all causes (time frame: 6-10 days after surgery). 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 NCT00396786.

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 28 Oct 2014.

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