Study 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

Inclusion Criteria
- 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
- 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

Products

Xarelto (Rivaroxaban, BAY59-7939)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed	Städtische Kliniken Frankfurt am Main / Hoechst	Frankfurt, 65929, Germany
Completed	Tel Aviv Sourasky Medical Center	Tel Aviv, 64239, Israel
Completed	Isala Klinieken, Locatie Sophia	ZWOLLE, 8025 AB, Netherlands
Completed	Regionshospitalet Silkeborg	Silkeborg, 8600, Denmark
Completed	Hopital Roger Salengro - Lille	LILLE CEDEX, 59037, France
Completed	Meander Medisch Centrum/Locatie De Lichtenberg	AMERSFOORT, 3818 ES, Netherlands
Completed	Notodden sykehus	Notodden, NO-3675, Norway
Completed	Donauspital im SMZ-Ost der Stadt Wien	Wien, 1220, Austria
Completed	UZ Brussel	BRUXELLES, 1090, Belgium
Completed	Herlev Hospital	Herlev, 2730, Denmark
Completed	Lovisenberg Diakonale sykehus	Oslo, 0440, Norway
Completed	SP Szpital Kliniczny AM w Bialymstoku	Bialystok, 15-276, Poland
Completed	Gentofte Hospital	Hellerup, 2900, Denmark
Completed	Wojewodzki Szpital Specjalistyczny im. Rydygiera	Krakow, 31-826, Poland
Completed	Chaim Sheba Medical Center	Tel Hashomer, 52621, Israel
Completed	Kungälvs Sjukhus	Kungälv, 442 83, Sweden
Completed	Allgem. öffentl. Krankenhaus Wiener Neustadt	Wiener Neustadt, 2700, Austria
Completed	RHMS Site Louis Caty	BAUDOUR, 7331, Belgium
Completed	Nordsjællands Hospital - Hørsholm	Hørsholm, DK-2970, Denmark
Completed	Kings College Hospital	London, SE5 9RS, United Kingdom
Active, not recruiting	Helse Blefjell Rjukan sykehus	Rjukan, NO-3660, Norway
Completed	Samodzielny Publiczny Szpital Kliniczny nr 4	Lublin, 20-090, Poland
Completed	SU/Östra	Göteborg, 416 85, Sweden
Completed	Krankenhaus der Barmherzigen Schwestern Linz	Linz, 4010, Austria
Completed	Orthopädische Universitätsklinik - Friedrichsheim	Frankfurt, 60528, Germany
Completed	Wojewodzki Szpital Specjalistyczny im. S. Wyszynskiego SPZOZ	Lublin, 20-718, Poland
Completed	Länssjukhuset Ryhov	Jönköping, 551 85, Sweden
Completed	Hôpital Nord - Amiens	AMIENS, 80030, France
Completed	Assaf Harofeh Medical Center	Zerifin, 70300, Israel
Completed	UZ Gent	GENT, 9000, Belgium
Completed	Hopital Central - Nancy	NANCY, 54037, France
Completed	Wojskowy Instytut Medyczny	Warszawa, 00-909, Poland
Completed	Klinikum Fürth	Fürth, 90766, Germany
Completed	Rambam Medical Center	Haifa, 31096, Israel
Completed	Medizinische Fakultät Carl Gustav Carus	Dresden, 01307, Germany
Completed	Kreiskrankenhaus Rheinfelden	Rheinfelden, 79618, Germany
Completed	CHR de Huy	HUY, 4500, Belgium
Completed	Uniwersytet Medyczny	Lodz, 91-425, Poland
Completed	Klinikum Garmisch-Partenkirchen	Garmisch-Partenkirchen, 82467, Germany
Completed	Szpital Kliniczny nr 3	Gdansk, 80-742, Poland
Completed	Helios Klinikum Emil von Behring	Berlin, 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.
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
Safety Issue:
yes

Secondary Outcome

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

Additional Information

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