check_circleStudy Completed

Thromboembolism, Prevention

Bayer Identifier:

10942

ClinicalTrials.gov Identifier:

NCT00839826

EudraCT Number:

Not Available

EU CT Number:

Not Available
ODiXahip - a Phase IIa Dose Escalating Proof of Principle Trial

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

18 Years
  • - 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.
  • - 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
    - 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 summary

Enrollment Goal
641
Trial Dates
December 2002 - December 2003
Phase
Phase 2
Could I Receive a placebo
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Städtische Kliniken Frankfurt am Main / HoechstFrankfurt, 65929, Germany
Completed
Tel Aviv Sourasky Medical CenterTel Aviv, 64239, Israel
Completed
Isala Klinieken, Locatie SophiaZWOLLE, 8025 AB, Netherlands
Completed
Regionshospitalet SilkeborgSilkeborg, 8600, Denmark
Completed
Hopital Roger Salengro - LilleLILLE CEDEX, 59037, France
Completed
Meander Medisch Centrum/Locatie De LichtenbergAMERSFOORT, 3818 ES, Netherlands
Completed
Notodden sykehusNotodden, NO-3675, Norway
Completed
Donauspital im SMZ-Ost der Stadt WienWien, 1220, Austria
Completed
UZ BrusselBRUXELLES, 1090, Belgium
Completed
Herlev HospitalHerlev, 2730, Denmark
Completed
Lovisenberg Diakonale sykehusOslo, 0440, Norway
Completed
SP Szpital Kliniczny AM w BialymstokuBialystok, 15-276, Poland
Completed
Gentofte HospitalHellerup, 2900, Denmark
Completed
Wojewodzki Szpital Specjalistyczny im. RydygieraKrakow, 31-826, Poland
Completed
Chaim Sheba Medical CenterTel Hashomer, 52621, Israel
Completed
Kungälvs SjukhusKungälv, 442 83, Sweden
Completed
Allgem. öffentl. Krankenhaus Wiener NeustadtWiener Neustadt, 2700, Austria
Completed
RHMS Site Louis CatyBAUDOUR, 7331, Belgium
Completed
Nordsjællands Hospital - HørsholmHørsholm, DK-2970, Denmark
Completed
Kings College HospitalLondon, SE5 9RS, United Kingdom
Active, not recruiting
Helse Blefjell Rjukan sykehusRjukan, NO-3660, Norway
Completed
Samodzielny Publiczny Szpital Kliniczny nr 4Lublin, 20-090, Poland
Completed
SU/ÖstraGöteborg, 416 85, Sweden
Completed
Krankenhaus der Barmherzigen Schwestern LinzLinz, 4010, Austria
Completed
Orthopädische Universitätsklinik - FriedrichsheimFrankfurt, 60528, Germany
Completed
Wojewodzki Szpital Specjalistyczny im. S. Wyszynskiego SPZOZLublin, 20-718, Poland
Completed
Länssjukhuset RyhovJönköping, 551 85, Sweden
Completed
Hôpital Nord - AmiensAMIENS, 80030, France
Completed
Assaf Harofeh Medical CenterZerifin, 70300, Israel
Completed
UZ GentGENT, 9000, Belgium
Completed
Hopital Central - NancyNANCY, 54037, France
Completed
Wojskowy Instytut MedycznyWarszawa, 00-909, Poland
Completed
Klinikum FürthFürth, 90766, Germany
Completed
Rambam Medical CenterHaifa, 31096, Israel
Completed
Medizinische Fakultät Carl Gustav CarusDresden, 01307, Germany
Completed
Kreiskrankenhaus RheinfeldenRheinfelden, 79618, Germany
Completed
CHR de HuyHUY, 4500, Belgium
Completed
Uniwersytet MedycznyLodz, 91-425, Poland
Completed
Klinikum Garmisch-PartenkirchenGarmisch-Partenkirchen, 82467, Germany
Completed
Szpital Kliniczny nr 3Gdansk, 80-742, Poland
Completed
Helios Klinikum Emil von BehringBerlin, 14165, Germany

Primary Outcome

  • 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.
    date_rangeTime 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
    enhanced_encryption
    Safety Issue:
    yes

Secondary Outcome

  • Incidence of DVTs (total, proximal, distal)
    date_rangeTime Frame:
    will be evaluated 5 - 9 days after surgery.
    enhanced_encryption
    Safety Issue:
    yes
  • Incidence of symptomatic VTEs
    date_rangeTime Frame:
    41 days after surgery
    enhanced_encryption
    Safety Issue:
    yes
  • The composite endpoint that results from the primary endpoint by using alternative definition of deaths (i.e. VTE related death)
    date_rangeTime Frame:
    41 days after surgery
    enhanced_encryption
    Safety Issue:
    yes
  • Incidence of symptomatic VTEs (total, PE, DVT) within 30 days after stop of treatment with the study drug.
    date_rangeTime Frame:
    41 days after surgery
    enhanced_encryption
    Safety Issue:
    yes

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Prevention
Allocation
Randomized
Blinding
Open Label
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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