Clinical trial NCT00396786: Dose-ranging Study of Once-daily Regimen of BAY 59-7939 in the Prevention of VTE in Patients Undergoing Elective Total Hip Replacement
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Venous Thromboembolism
Keywords: Prevention of venous thromboembolism
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2006-11-07
Enrollment: 877
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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. 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.


Eligibility criteria: 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:
* 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
  * 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

Primary outcomes:
measure: Composite Endpoint of Deep Vein Thrombosis (DVT), non-fatal Pulmonary Embolism (PE) and Death from all causes
timeFrame: 6-10 days after surgery
Secondary outcomes:
measure: Incidence of DVTs (total, proximal, distal)
timeFrame: 6-10 days after surgery
measure: Incidence of symptomatic Venous Thrombo Embolisms (VTEs)
timeFrame: 6-10 days after surgery
measure: Incidence of major VTE (ie, Proximal DVT, PE or VTE-related death)
timeFrame: 6-10 days after surgery
measure: The composite endpoint that results from the primary endpoint by substituting VTE related death for all death
timeFrame: 40 days
measure: Incidence of symptomatic VTEs (total, PE, DVT) within 30 days after stop of treatment with the study drug
timeFrame: 40 days
Other outcomes:
Locations:
city: Wiener Neustadt
country: Austria
state: Niederösterreich
city: Linz
country: Austria
state: Oberösterreich
city: Linz
country: Austria
state: Oberösterreich
city: Wien
country: Austria
city: Antwerpen
country: Belgium
city: Bonheiden
country: Belgium
city: Genk
country: Belgium
city: Hasselt
country: Belgium
city: Hellerup
country: Denmark
city: Herlev
country: Denmark
city: Hørsholm
country: Denmark
city: Silkeborg
country: Denmark
city: Paris Cedex 14
country: France
city: Paris Cedex 19
country: France
city: Poitiers
country: France
city: Saint Herblain
country: France
city: Rheinfelden
country: Germany
state: Baden-Württemberg
city: Fürth
country: Germany
state: Bayern
city: Garmisch-Partenkirchen
country: Germany
state: Bayern
city: Sommerfeld
country: Germany
state: Brandenburg
city: Frankfurt
country: Germany
state: Hessen
city: Frankfurt
country: Germany
state: Hessen
city: Marburg
country: Germany
state: Hessen
city: Melsungen
country: Germany
state: Hessen
city: Düsseldorf
country: Germany
state: Nordrhein-Westfalen
city: Dresden
country: Germany
state: Sachsen
city: Petach Tikva
country: Israel
state: Isarel
city: Haifa
country: Israel
city: Holon
country: Israel
city: Kfar Saba
country: Israel
city: Petach Tikva
country: Israel
city: Tel Aviv
country: Israel
city: Zerifin
country: Israel
city: Monza
country: Italy
state: Milano
city: Rozzano
country: Italy
state: Milano
city: Gubbio
country: Italy
state: Perugia
city: Bologna
country: Italy
city: Milano
country: Italy
city: Milano
country: Italy
city: Hilversum
country: Netherlands
city: Hoofddorp
country: Netherlands
city: Nijmegen
country: Netherlands
city: Notodden
country: Norway
city: Oslo
country: Norway
city: Rjukan
country: Norway
city: Bialystok
country: Poland
city: Gdansk
country: Poland
city: Krakow
country: Poland
city: Lublin
country: Poland
city: Lublin
country: Poland
city: Warszawa
country: Poland
city: Badalona
country: Spain
state: Barcelona
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Madrid
country: Spain
city: Valencia
country: Spain
city: Göteborg
country: Sweden
city: Halmstad
country: Sweden
city: Jönköping
country: Sweden
city: Kungälv
country: Sweden
city: London
country: United Kingdom
state: Greater London
city: London
country: United Kingdom
state: Greater London
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: