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ODiXahip - a Phase IIa Dose Escalating Proof of Principle Trial (ODiXaHip)

Primary Purpose

Thromboembolism, Prevention

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Rivaroxaban (BAY59-7939)

Enoxaparin

About this trial

This is an interventional prevention trial for Thromboembolism focused on measuring Prevention of Thromboembolism after total hip replacement

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm 2

Arm 1

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Incidence of DVTs (total, proximal, distal)

Incidence of symptomatic VTEs

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

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

Full Information

NCT ID

NCT00839826

First Posted

February 9, 2009

Last Updated

December 15, 2014

Sponsor

Bayer

1. Study Identification

Unique Protocol Identification Number

NCT00839826

Brief Title

ODiXahip - a Phase IIa Dose Escalating Proof of Principle Trial

Acronym

ODiXaHip

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2014

Overall Recruitment Status

Completed

Study Start Date

December 2002 (undefined)

Primary Completion Date

November 2003 (Actual)

Study Completion Date

November 2003 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bayer

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Thromboembolism, Prevention

Keywords

Prevention of Thromboembolism after total hip replacement

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

641 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 2

Arm Type

Active Comparator

Arm Title

Arm 1

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Rivaroxaban (BAY59-7939)

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Enoxaparin

Intervention Description

40 mg bid

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

Incidence of DVTs (total, proximal, distal)

Time Frame

will be evaluated 5 - 9 days after surgery.

Title

Incidence of symptomatic VTEs

Time Frame

41 days after surgery

Title

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

Title

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

Time Frame

41 days after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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: 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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bayer Study Director

Organizational Affiliation

Bayer

Official's Role

Study Director

Facility Information:

City

Wiener Neustadt

State/Province

Niederösterreich

ZIP/Postal Code

2700

Country

Austria

City

Linz

State/Province

Oberösterreich

ZIP/Postal Code

4010

Country

Austria

City

Wien

ZIP/Postal Code

1220

Country

Austria

City

Baudour

ZIP/Postal Code

7331

Country

Belgium

City

Bruxelles

ZIP/Postal Code

1090

Country

Belgium

City

Gent

ZIP/Postal Code

9000

Country

Belgium

City

HUY

ZIP/Postal Code

4500

Country

Belgium

City

Hellerup

ZIP/Postal Code

2900

Country

Denmark

City

Herlev

ZIP/Postal Code

2730

Country

Denmark

City

Hørsholm

ZIP/Postal Code

DK-2970

Country

Denmark

City

Silkeborg

ZIP/Postal Code

8600

Country

Denmark

City

Amiens

ZIP/Postal Code

80030

Country

France

City

Lille Cedex

ZIP/Postal Code

59037

Country

France

City

Nancy

ZIP/Postal Code

54037

Country

France

City

Rheinfelden

State/Province

Baden-Württemberg

ZIP/Postal Code

79618

Country

Germany

City

Fürth

State/Province

Bayern

ZIP/Postal Code

90766

Country

Germany

City

Garmisch-Partenkirchen

State/Province

Bayern

ZIP/Postal Code

82467

Country

Germany

City

Frankfurt

State/Province

Hessen

ZIP/Postal Code

60528

Country

Germany

City

Frankfurt

State/Province

Hessen

ZIP/Postal Code

65929

Country

Germany

City

Dresden

State/Province

Sachsen

ZIP/Postal Code

01307

Country

Germany

City

Berlin

ZIP/Postal Code

14165

Country

Germany

City

Haifa

ZIP/Postal Code

31096

Country

Israel

City

Tel Aviv

ZIP/Postal Code

64239

Country

Israel

City

Tel Hashomer

ZIP/Postal Code

52621

Country

Israel

City

Zerifin

ZIP/Postal Code

70300

Country

Israel

City

Amersfoort

ZIP/Postal Code

3818 ES

Country

Netherlands

City

Zwolle

ZIP/Postal Code

8025 AB

Country

Netherlands

City

Notodden

ZIP/Postal Code

NO-3675

Country

Norway

City

Oslo

ZIP/Postal Code

0440

Country

Norway

City

Rjukan

ZIP/Postal Code

NO-3660

Country

Norway

City

Bialystok

ZIP/Postal Code

15-276

Country

Poland

City

Gdansk

ZIP/Postal Code

80-742

Country

Poland

City

Krakow

ZIP/Postal Code

31-826

Country

Poland

City

Lodz

ZIP/Postal Code

91-425

Country

Poland

City

Lublin

ZIP/Postal Code

20-090

Country

Poland

City

Lublin

ZIP/Postal Code

20-718

Country

Poland

City

Warszawa

ZIP/Postal Code

00-909

Country

Poland

City

Göteborg

ZIP/Postal Code

416 85

Country

Sweden

City

Jönköping

ZIP/Postal Code

551 85

Country

Sweden

City

Kungälv

ZIP/Postal Code

442 83

Country

Sweden

City

London

State/Province

Greater London

ZIP/Postal Code

SE5 9RS

Country

United Kingdom

12. IPD Sharing Statement

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ODiXahip - a Phase IIa Dose Escalating Proof of Principle Trial

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