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ThromboembolismPhase 2ODiXaHipNCT00839826

ODiXahip - a Phase IIa Dose Escalating Proof of Principle Trial

A Phase 2 study testing Rivaroxaban (BAY59-7939) and Enoxaparin in people with Thromboembolism and Prevention, run by Bayer at 41 sites in 11 countries.

Completed

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

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Thromboembolism, Prevention
What is being tested?
Rivaroxaban (BAY59-7939) and Enoxaparin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
641 participants
Where
41 sitesin 11 countries
Study dates
Dec 2002to Nov 2003
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.

Who cannot join

  • 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
Show all 24Show fewer
  • 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).

Trial locations and contacts

41 sites in 11 countries.

41 sites in 11 countries

Germany7 sites

  • Study site

    Berlin, State of Berlin, 14165

  • Study site

    Dresden, Saxony, 01307

  • 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

    Rheinfelden, Baden-Wurttemberg, 79618

Other trials in Germany

Poland7 sites

  • Study site

    Bialystok, 15-276

  • Study site

    Gdansk, 80-742

  • Study site

    Krakow, 31-826

  • Study site

    Lodz, 91-425

  • Study site

    Lublin, 20-090

  • Study site

    Lublin, 20-718

  • Study site

    Warsaw, 00-909

Other trials in Poland

Belgium4 sites

  • Study site

    Baudour, 7331

  • Study site

    Brussels, 1090

  • Study site

    Ghent, 9000

  • Study site

    Huy, 4500

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

Israel4 sites

  • Study site

    Haifa, Israel, 31096

  • Study site

    Tel Aviv, 64239

  • Study site

    Tel HaShomer, 52621

  • Study site

    Tsrifin, 70300

Other trials in Israel

Austria3 sites

  • Study site

    Linz, Upper Austria, 4010

  • Study site

    Vienna, State of Vienna, 1220

  • Study site

    Wiener Neustadt, Lower Austria, 2700

Other trials in Austria

France3 sites

  • Study site

    Amiens, 80030

  • Study site

    Lille, 59037

  • Study site

    Nancy, 54037

Other trials in France

Norway3 sites

  • Study site

    Notodden, NO-3675

  • Study site

    Oslo, 0440

  • Study site

    Rjukan, NO-3660

Other trials in Norway

Sweden3 sites

  • Study site

    Gothenburg, 416 85

  • Study site

    Jönköping, 551 85

  • Study site

    Kungälv, 442 83

Other trials in Sweden

Netherlands2 sites

  • Study site

    Amersfoort, 3818 ES

  • Study site

    Zwolle, 8025 AB

Other trials in Netherlands

United Kingdom1 site

  • Study site

    London, Greater London, SE5 9RS

Other trials in United Kingdom

About this study

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

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.

Being tested
Rivaroxaban (BAY59-7939), Enoxaparin
Keywords
Prevention of Thromboembolism after total hip replacement
Medical subject headings
Thromboembolism

What participants receive

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

  • Rivaroxaban (BAY59-7939)Drug

    2,5 mg bid,5 mg bid,10mg bid, 20 mg bid, 20 mg tid, 30 mg bid, dose escalation trial

  • EnoxaparinDrug

    40 mg bid

Study groups in NCT00839826
Study groupRoleWhat they receive
Arm 2Active comparatorNot described
Receives: Drug: Enoxaparin
Arm 1ExperimentalNot described
Receives: Drug: Rivaroxaban (BAY59-7939)

What is being measured

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

  1. 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.

    Measured: 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

Secondary outcomes (4)

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

    Measured: will be evaluated 5 - 9 days after surgery.

  2. Incidence of symptomatic VTEs

    Measured: 41 days after surgery

  3. The composite endpoint that results from the primary endpoint by using alternative definition of deaths (i.e. VTE related death)

    Measured: 41 days after surgery

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

    Measured: 41 days after surgery

Timeline

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

  1. First posted10 Feb 2009 (estimated)
  2. Study startDec 2002
  3. Primary completionNov 2003
  4. Study completionNov 2003

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
None (open label)
Enrolment
641 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00839826
Sponsor's protocol ID
10942
Acronym
ODiXaHip
Status last verified
Dec 2014
First submitted
9 Feb 2009
Last updated
17 Dec 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Rivaroxaban (BAY59-7939) and Enoxaparin in people with Thromboembolism and Prevention, run by Bayer at 41 sites in 11 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 24 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 17 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 41 sites in Germany, Poland, Belgium, Denmark, Israel and 6 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?

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). 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 NCT00839826.

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 17 Dec 2014.

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