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Dabigatran Etexilate Compared With Enoxaparin in Prevention of Venous Thromboembolism (VTE) Following Total Hip Arthroplasty

Primary Purpose

Venous Thromboembolism

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Enoxaparin
Dabigatran etexilate
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Venous Thromboembolism

Eligibility Criteria

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

Inclusion criteria:

  • Patients scheduled to undergo primary, unilateral, elective total hip arthroplasty.
  • Male or female 18 years of age or older.
  • Patients giving written informed consent for study participation.

Exclusion criteria:

  • Patients weighing less than 40 kg.
  • History of bleeding diathesis.
  • Patients who in the investigators judgement are perceived as having an excessive risk of bleeding, for example, constitutional or acquired coagulation disorders or because of anticipated need of quinidine, verapamil or other restricted medication during the treatment period (see Section 4.2.2).
  • Major surgery or trauma (e.g., hip fracture) within 3 months of enrolment.
  • Recent unstable cardiovascular disease (in the investigators opinion) such as uncontrolled hypertension, that is ongoing at the time of enrolment or history of myocardial infarction within 3 months of enrolment.
  • Any history of haemorrhagic stroke or any of the following intracranial pathologies: bleeding, neoplasm, Atriovenous (AV) malformation or aneurysm.
  • Ongoing treatment for Venous Thromboembolism (VTE).
  • Clinically relevant bleeding (gastrointestinal, pulmonary, intraocular or urogenital bleeding) within 6 months of enrolment.
  • Gastric or duodenal ulcer within one year of enrolment.
  • Liver disease expected to have any potential impact on survival (ie, hepatitis B or C, cirrhosis). This does not include Gilberts syndrome or hepatitis A with complete recovery.
  • Active liver disease or liver disease decreasing survival (e.g, acute hepatitis, chronic active hepatitis, cirrhosis) or Alanine Aminotransferase (ALT) >3 x ULN.
  • Known severe renal insufficiency (CrCl <30 ml/min). Note: CrCl should be calculated only if serum creatinine is elevated or renal insufficiency is suspected. See Appendix 10.1 for calculation.
  • Elevated creatinine that, in the investigators opinion, contraindicates venography.
  • Treatment with anticoagulants, clopidogrel, ticlopidine, abciximab, aspirin >162.5 mg/day or NSAID with t 1/2 >12 hours within 7 days prior to hip replacement surgery OR anticipated need while the patient is receiving study medication and prior to 24 hours after the last administration of any blinded study medication (COX-2 selective inhibitors are allowed).
  • Anticipated required use of intermittent pneumatic compression and electric stimulation of lower limb.

  • Pre-menopausal women (last menstruation within 1 year prior to signing informed consent) who:

    • Are pregnant.
    • Are nursing.
    • Are of child-bearing potential and are NOT practicing acceptable methods of birth control, or do NOT plan to continue practicing an acceptable method throughout the study. Acceptable methods of birth control include intrauterine device; oral, implantable or injectable contraceptives and surgical sterility.
  • Known allergy to radio opaque contrast media.
  • History of thrombocytopenia, including heparin-induced thrombocytopenia, or a platelet count <100,000 cells/microliter at randomisation.
  • Allergy to heparins or dabigatran etexilate.
  • Active malignant disease or current cytostatic treatment. Patients should be disease free for at least 5 years.
  • Participation in a clinical trial within 30 days of randomisation.
  • Leg amputee.
  • Known alcohol or drug abuse which would interfere with completion of the study.
  • Contraindications to enoxaparin.
  • Previous participation in this study.

Sites / Locations

  • 1160.64.01005 Boehringer Ingelheim Investigational Site
  • 1160.64.01010 Boehringer Ingelheim Investigational Site
  • 1160.64.01009 Boehringer Ingelheim Investigational Site
  • 1160.64.01012 Boehringer Ingelheim Investigational Site
  • 1160.64.01006 Boehringer Ingelheim Investigational Site
  • 1160.64.01003 Boehringer Ingelheim Investigational Site
  • 1160.64.01007 Boehringer Ingelheim Investigational Site
  • 1160.64.01013 Boehringer Ingelheim Investigational Site
  • 1160.64.01002 Boehringer Ingelheim Investigational Site
  • 1160.64.01011 Boehringer Ingelheim Investigational Site
  • 1160.64.2003 Boehringer Ingelheim Investigational Site
  • 1160.64.2002 Boehringer Ingelheim Investigational Site
  • 1160.64.2001 Boehringer Ingelheim Investigational Site
  • 1160.64.2004 Boehringer Ingelheim Investigational Site
  • 1160.64.4004 Boehringer Ingelheim Investigational Site
  • 1160.64.4002 Boehringer Ingelheim Investigational Site
  • 1160.64.4003 Boehringer Ingelheim Investigational Site
  • 1160.64.4001 Boehringer Ingelheim Investigational Site
  • 1160.64.5004 Boehringer Ingelheim Investigational Site
  • 1160.64.5002 Boehringer Ingelheim Investigational Site
  • 1160.64.5005 Boehringer Ingelheim Investigational Site
  • 1160.64.5001 Boehringer Ingelheim Investigational Site
  • 1160.64.6009 Boehringer Ingelheim Investigational Site
  • 1160.64.6002 Boehringer Ingelheim Investigational Site
  • 1160.64.6012 Boehringer Ingelheim Investigational Site
  • 1160.64.6003 Boehringer Ingelheim Investigational Site
  • 1160.64.6004 Boehringer Ingelheim Investigational Site
  • 1160.64.6008 Boehringer Ingelheim Investigational Site
  • 1160.64.6011 Boehringer Ingelheim Investigational Site
  • 1160.64.6005 Boehringer Ingelheim Investigational Site
  • 1160.64.6007 Boehringer Ingelheim Investigational Site
  • 1160.64.6013 Boehringer Ingelheim Investigational Site
  • 1160.64.7004 Boehringer Ingelheim Investigational Site
  • 1160.64.7005 Boehringer Ingelheim Investigational Site
  • 1160.64.7003 Boehringer Ingelheim Investigational Site
  • 1160.64.7001 Boehringer Ingelheim Investigational Site
  • 1160.64.7002 Boehringer Ingelheim Investigational Site
  • 1160.64.8004 Boehringer Ingelheim Investigational Site
  • 1160.64.8003 Boehringer Ingelheim Investigational Site
  • 1160.64.8001 Boehringer Ingelheim Investigational Site
  • 1160.64.8002 Boehringer Ingelheim Investigational Site
  • 1160.64.9002 Boehringer Ingelheim Investigational Site
  • 1160.64.9001 Boehringer Ingelheim Investigational Site
  • 1160.64.9003 Boehringer Ingelheim Investigational Site
  • 1160.64.1104 Boehringer Ingelheim Investigational Site
  • 1160.64.1101 Boehringer Ingelheim Investigational Site
  • 1160.64.1103 Boehringer Ingelheim Investigational Site
  • 1160.64.1102 Boehringer Ingelheim Investigational Site
  • 1160.64.1201 Boehringer Ingelheim Investigational Site
  • 1160.64.1203 Boehringer Ingelheim Investigational Site
  • 1160.64.1202 Boehringer Ingelheim Investigational Site
  • 1160.64.1204 Boehringer Ingelheim Investigational Site
  • 1160.64.9105 Boehringer Ingelheim Investigational Site
  • 1160.64.9112 Boehringer Ingelheim Investigational Site
  • 1160.64.9109 Boehringer Ingelheim Investigational Site
  • 1160.64.9103 Boehringer Ingelheim Investigational Site
  • 1160.64.9108 Boehringer Ingelheim Investigational Site
  • 1160.64.9107 Boehringer Ingelheim Investigational Site
  • 1160.64.9110 Boehringer Ingelheim Investigational Site
  • 1160.64.9104 Boehringer Ingelheim Investigational Site
  • 1160.64.9111 Boehringer Ingelheim Investigational Site
  • 1160.64.9106 Boehringer Ingelheim Investigational Site
  • 1160.64.9101 Boehringer Ingelheim Investigational Site
  • 1160.64.9102 Boehringer Ingelheim Investigational Site
  • 1160.64.9113 Boehringer Ingelheim Investigational Site
  • 1160.64.1401 Boehringer Ingelheim Investigational Site
  • 1160.64.1405 Boehringer Ingelheim Investigational Site
  • 1160.64.1402 Boehringer Ingelheim Investigational Site
  • 1160.64.1407 Boehringer Ingelheim Investigational Site
  • 1160.64.1403 Boehringer Ingelheim Investigational Site
  • 1160.64.1404 Boehringer Ingelheim Investigational Site
  • 1160.64.1503 Boehringer Ingelheim Investigational Site
  • 1160.64.1507 Boehringer Ingelheim Investigational Site
  • 1160.64.1501 Boehringer Ingelheim Investigational Site
  • 1160.64.1506 Boehringer Ingelheim Investigational Site
  • 1160.64.1510 Boehringer Ingelheim Investigational Site
  • 1160.64.1505 Boehringer Ingelheim Investigational Site
  • 1160.64.1508 Boehringer Ingelheim Investigational Site
  • 1160.64.3001 Boehringer Ingelheim Investigational Site
  • 1160.64.1601 Boehringer Ingelheim Investigational Site
  • 1160.64.1606 Boehringer Ingelheim Investigational Site
  • 1160.64.1604 Boehringer Ingelheim Investigational Site
  • 1160.64.1605 Boehringer Ingelheim Investigational Site
  • 1160.64.1603 Boehringer Ingelheim Investigational Site
  • 1160.64.1702 Boehringer Ingelheim Investigational Site
  • 1160.64.1704 Boehringer Ingelheim Investigational Site
  • 1160.64.1705 Boehringer Ingelheim Investigational Site
  • 1160.64.1703 Boehringer Ingelheim Investigational Site
  • 1160.64.1701 Boehringer Ingelheim Investigational Site
  • 1160.64.1801 Boehringer Ingelheim Investigational Site
  • 1160.64.1804 Boehringer Ingelheim Investigational Site
  • 1160.64.1802 Boehringer Ingelheim Investigational Site
  • 1160.64.1904 Boehringer Ingelheim Investigational Site
  • 1160.64.1906 Boehringer Ingelheim Investigational Site
  • 1160.64.1908 Boehringer Ingelheim Investigational Site
  • 1160.64.1901 Boehringer Ingelheim Investigational Site
  • 1160.64.1907 Boehringer Ingelheim Investigational Site
  • 1160.64.1905 Boehringer Ingelheim Investigational Site
  • 1160.64.2101 Boehringer Ingelheim Investigational Site
  • 1160.64.2112 Boehringer Ingelheim Investigational Site
  • 1160.64.2105 Boehringer Ingelheim Investigational Site
  • 1160.64.2109 Boehringer Ingelheim Investigational Site
  • 1160.64.2103 Boehringer Ingelheim Investigational Site
  • 1160.64.2106 Boehringer Ingelheim Investigational Site
  • 1160.64.2102 Boehringer Ingelheim Investigational Site
  • 1160.64.2108 Boehringer Ingelheim Investigational Site
  • 1160.64.2111 Boehringer Ingelheim Investigational Site
  • 1160.64.2107 Boehringer Ingelheim Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dabigatran etexilate

Enoxaparin

Arm Description

220 mg once daily

40 mg once daily

Outcomes

Primary Outcome Measures

Number of Participants With Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period
Total Venous Thromboembolic Event (VTE) includes both proximal and distal deep vein thrombosis (DVT) (detected by routine venography), symptomatic DVT (confirmed by venous duplex, ultrasound, venography or autopsy) and pulmonary embolism (PE) (confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy). All of these components and all deaths were centrally adjudicated by the VTE events committee, which was not aware of the treatment allocation of the patients.

Secondary Outcome Measures

Number of Participants With Major Venous Thromboembolic Event and Venous Thromboembolic Event-related Mortality During Treatment Period
Major Venous Thromboembolic Event (VTE) is defined as proximal DVT and PE, as adjudicated by the VTE events committee
Number of Participants With Proximal Deep Vein Thrombosis During Treatment Period
Proximal Deep Vein Thrombosis as adjudicated by the VTE events committee
Number of Participants With Total Deep Vein Thrombosis During Treatment Period
Total Deep Vein Thrombosis as adjudicated by the VTE events committee
Number of Participants With Symptomatic Deep Vein Thrombosis During Treatment Period
Symptomatic Deep Vein Thrombosis, confirmed by venous duplex, ultrasound, venography or autopsy, and as adjudicated by the VTE events committee
Number of Participants With Pulmonary Embolism During Treatment Period
Pulmonary embolism confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy, and as adjudicated by the VTE events committee
Number of Participants Who Died During Treatment Period
All cause death, as adjudicated by the VTE events committee
Number of Participants With Total Venous Thromboembolic Event (VTE) and All-cause Mortality During the Follow-up Period
Total Venous Thromboembolic Event (VTE) includes both proximal and distal deep vein thrombosis (DVT) (detected by routine venography), symptomatic DVT (confirmed by venous duplex, ultrasound, venography or autopsy) and pulmonary embolism (PE) (confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy).
Number of Participants With Bleeding Events (Defined According to Modified McMaster Criteria) During Treatment Period
Major bleeding events were defined as fatal clinically overt associated with loss of haemoglobin >=20g/L in excess of what was expected clinically overt leading to the transfusion of >=2 units packed cells or whole blood in excess of what was expected symptomatic retroperitoneal, intracranial, intraocular or intraspinal requiring treatment cessation leading to re-operation Clinically-relevant was defined as spontaneous skin hematoma >=25 cm² wound hematoma >=100 cm² spontaneous nose bleed >5 min macroscopic hematuria spontaneous or >24 hours if associated with an intervention spontaneous rectal bleeding gingival bleeding >5 min any other bleeding event considered clinically relevant by the investigator Any bleeding events were defined as major, clinically-relevant and minor bleeding events. Minor bleeding events were defined as all other bleeding events that did not fulfil the criteria from above.
Blood Transfusion
Number of treated and operated patients with required blood transfusion on day of surgery.
Volume of Blood Loss
Volume of blood loss for treated and operated patients during surgery.
Laboratory Analyses
Frequency of patients with possible clinically significant abnormalities.

Full Information

First Posted
March 27, 2008
Last Updated
June 23, 2014
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT00657150
Brief Title
Dabigatran Etexilate Compared With Enoxaparin in Prevention of Venous Thromboembolism (VTE) Following Total Hip Arthroplasty
Official Title
A Phase III Randomised, Parallel Group, Double-blind, Active Controlled Study to Investigate the Efficacy and Safety of Orally Administered 220 mg Dabigatran Etexilate Capsules (110 mg Administered on the Day of Surgery Followed by 220 mg Once Daily) Compared to Subcutaneous 40 mg Enoxaparin Once Daily for 28-35 Days, in Prevention of Venous Thromboembolism in Patients With Primary Elective Total Hip Arthroplasty Surgery. (RE-NOVATE II)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim

4. Oversight

5. Study Description

Brief Summary
The primary objective of the trial is to demonstrate non-inferiority of 220 mg oral dabigatran etexilate compared to 40 mg subcutaneous enoxaparin administered once daily. Safety and efficacy will be compared between the treatment groups.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
2055 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dabigatran etexilate
Arm Type
Experimental
Arm Description
220 mg once daily
Arm Title
Enoxaparin
Arm Type
Active Comparator
Arm Description
40 mg once daily
Intervention Type
Drug
Intervention Name(s)
Enoxaparin
Intervention Description
40 mg once daily
Intervention Type
Drug
Intervention Name(s)
Dabigatran etexilate
Intervention Description
220 mg once daily
Primary Outcome Measure Information:
Title
Number of Participants With Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period
Description
Total Venous Thromboembolic Event (VTE) includes both proximal and distal deep vein thrombosis (DVT) (detected by routine venography), symptomatic DVT (confirmed by venous duplex, ultrasound, venography or autopsy) and pulmonary embolism (PE) (confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy). All of these components and all deaths were centrally adjudicated by the VTE events committee, which was not aware of the treatment allocation of the patients.
Time Frame
28-35 days
Secondary Outcome Measure Information:
Title
Number of Participants With Major Venous Thromboembolic Event and Venous Thromboembolic Event-related Mortality During Treatment Period
Description
Major Venous Thromboembolic Event (VTE) is defined as proximal DVT and PE, as adjudicated by the VTE events committee
Time Frame
28-35 days
Title
Number of Participants With Proximal Deep Vein Thrombosis During Treatment Period
Description
Proximal Deep Vein Thrombosis as adjudicated by the VTE events committee
Time Frame
28-35 days
Title
Number of Participants With Total Deep Vein Thrombosis During Treatment Period
Description
Total Deep Vein Thrombosis as adjudicated by the VTE events committee
Time Frame
28-35 days
Title
Number of Participants With Symptomatic Deep Vein Thrombosis During Treatment Period
Description
Symptomatic Deep Vein Thrombosis, confirmed by venous duplex, ultrasound, venography or autopsy, and as adjudicated by the VTE events committee
Time Frame
28-35 days
Title
Number of Participants With Pulmonary Embolism During Treatment Period
Description
Pulmonary embolism confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy, and as adjudicated by the VTE events committee
Time Frame
28-35 days
Title
Number of Participants Who Died During Treatment Period
Description
All cause death, as adjudicated by the VTE events committee
Time Frame
28-35 days
Title
Number of Participants With Total Venous Thromboembolic Event (VTE) and All-cause Mortality During the Follow-up Period
Description
Total Venous Thromboembolic Event (VTE) includes both proximal and distal deep vein thrombosis (DVT) (detected by routine venography), symptomatic DVT (confirmed by venous duplex, ultrasound, venography or autopsy) and pulmonary embolism (PE) (confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy).
Time Frame
3 months
Title
Number of Participants With Bleeding Events (Defined According to Modified McMaster Criteria) During Treatment Period
Description
Major bleeding events were defined as fatal clinically overt associated with loss of haemoglobin >=20g/L in excess of what was expected clinically overt leading to the transfusion of >=2 units packed cells or whole blood in excess of what was expected symptomatic retroperitoneal, intracranial, intraocular or intraspinal requiring treatment cessation leading to re-operation Clinically-relevant was defined as spontaneous skin hematoma >=25 cm² wound hematoma >=100 cm² spontaneous nose bleed >5 min macroscopic hematuria spontaneous or >24 hours if associated with an intervention spontaneous rectal bleeding gingival bleeding >5 min any other bleeding event considered clinically relevant by the investigator Any bleeding events were defined as major, clinically-relevant and minor bleeding events. Minor bleeding events were defined as all other bleeding events that did not fulfil the criteria from above.
Time Frame
28-35 days
Title
Blood Transfusion
Description
Number of treated and operated patients with required blood transfusion on day of surgery.
Time Frame
Day 1
Title
Volume of Blood Loss
Description
Volume of blood loss for treated and operated patients during surgery.
Time Frame
Day 1
Title
Laboratory Analyses
Description
Frequency of patients with possible clinically significant abnormalities.
Time Frame
First administration to end of study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Patients scheduled to undergo primary, unilateral, elective total hip arthroplasty. Male or female 18 years of age or older. Patients giving written informed consent for study participation. Exclusion criteria: Patients weighing less than 40 kg. History of bleeding diathesis. Patients who in the investigators judgement are perceived as having an excessive risk of bleeding, for example, constitutional or acquired coagulation disorders or because of anticipated need of quinidine, verapamil or other restricted medication during the treatment period (see Section 4.2.2). Major surgery or trauma (e.g., hip fracture) within 3 months of enrolment. Recent unstable cardiovascular disease (in the investigators opinion) such as uncontrolled hypertension, that is ongoing at the time of enrolment or history of myocardial infarction within 3 months of enrolment. Any history of haemorrhagic stroke or any of the following intracranial pathologies: bleeding, neoplasm, Atriovenous (AV) malformation or aneurysm. Ongoing treatment for Venous Thromboembolism (VTE). Clinically relevant bleeding (gastrointestinal, pulmonary, intraocular or urogenital bleeding) within 6 months of enrolment. Gastric or duodenal ulcer within one year of enrolment. Liver disease expected to have any potential impact on survival (ie, hepatitis B or C, cirrhosis). This does not include Gilberts syndrome or hepatitis A with complete recovery. Active liver disease or liver disease decreasing survival (e.g, acute hepatitis, chronic active hepatitis, cirrhosis) or Alanine Aminotransferase (ALT) >3 x ULN. Known severe renal insufficiency (CrCl <30 ml/min). Note: CrCl should be calculated only if serum creatinine is elevated or renal insufficiency is suspected. See Appendix 10.1 for calculation. Elevated creatinine that, in the investigators opinion, contraindicates venography. Treatment with anticoagulants, clopidogrel, ticlopidine, abciximab, aspirin >162.5 mg/day or NSAID with t 1/2 >12 hours within 7 days prior to hip replacement surgery OR anticipated need while the patient is receiving study medication and prior to 24 hours after the last administration of any blinded study medication (COX-2 selective inhibitors are allowed). Anticipated required use of intermittent pneumatic compression and electric stimulation of lower limb. Pre-menopausal women (last menstruation within 1 year prior to signing informed consent) who: Are pregnant. Are nursing. Are of child-bearing potential and are NOT practicing acceptable methods of birth control, or do NOT plan to continue practicing an acceptable method throughout the study. Acceptable methods of birth control include intrauterine device; oral, implantable or injectable contraceptives and surgical sterility. Known allergy to radio opaque contrast media. History of thrombocytopenia, including heparin-induced thrombocytopenia, or a platelet count <100,000 cells/microliter at randomisation. Allergy to heparins or dabigatran etexilate. Active malignant disease or current cytostatic treatment. Patients should be disease free for at least 5 years. Participation in a clinical trial within 30 days of randomisation. Leg amputee. Known alcohol or drug abuse which would interfere with completion of the study. Contraindications to enoxaparin. Previous participation in this study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
1160.64.01005 Boehringer Ingelheim Investigational Site
City
La Jolla
State/Province
California
Country
United States
Facility Name
1160.64.01010 Boehringer Ingelheim Investigational Site
City
Aurora
State/Province
Colorado
Country
United States
Facility Name
1160.64.01009 Boehringer Ingelheim Investigational Site
City
Englewood
State/Province
Colorado
Country
United States
Facility Name
1160.64.01012 Boehringer Ingelheim Investigational Site
City
Clearwater
State/Province
Florida
Country
United States
Facility Name
1160.64.01006 Boehringer Ingelheim Investigational Site
City
Lexington
State/Province
Kentucky
Country
United States
Facility Name
1160.64.01003 Boehringer Ingelheim Investigational Site
City
Missoula
State/Province
Montana
Country
United States
Facility Name
1160.64.01007 Boehringer Ingelheim Investigational Site
City
Charleston
State/Province
South Carolina
Country
United States
Facility Name
1160.64.01013 Boehringer Ingelheim Investigational Site
City
Conway
State/Province
South Carolina
Country
United States
Facility Name
1160.64.01002 Boehringer Ingelheim Investigational Site
City
Houston
State/Province
Texas
Country
United States
Facility Name
1160.64.01011 Boehringer Ingelheim Investigational Site
City
Spokane
State/Province
Washington
Country
United States
Facility Name
1160.64.2003 Boehringer Ingelheim Investigational Site
City
Daws Park
State/Province
South Australia
Country
Australia
Facility Name
1160.64.2002 Boehringer Ingelheim Investigational Site
City
Box HIll
State/Province
Victoria
Country
Australia
Facility Name
1160.64.2001 Boehringer Ingelheim Investigational Site
City
Windsor
State/Province
Victoria
Country
Australia
Facility Name
1160.64.2004 Boehringer Ingelheim Investigational Site
City
Nedlands
State/Province
Western Australia
Country
Australia
Facility Name
1160.64.4004 Boehringer Ingelheim Investigational Site
City
Graz
Country
Austria
Facility Name
1160.64.4002 Boehringer Ingelheim Investigational Site
City
Linz
Country
Austria
Facility Name
1160.64.4003 Boehringer Ingelheim Investigational Site
City
Wels
Country
Austria
Facility Name
1160.64.4001 Boehringer Ingelheim Investigational Site
City
Wien
Country
Austria
Facility Name
1160.64.5004 Boehringer Ingelheim Investigational Site
City
Brussel
Country
Belgium
Facility Name
1160.64.5002 Boehringer Ingelheim Investigational Site
City
Deurne
Country
Belgium
Facility Name
1160.64.5005 Boehringer Ingelheim Investigational Site
City
Lanaken
Country
Belgium
Facility Name
1160.64.5001 Boehringer Ingelheim Investigational Site
City
Leuven
Country
Belgium
Facility Name
1160.64.6009 Boehringer Ingelheim Investigational Site
City
Edmonton,
State/Province
Alberta
Country
Canada
Facility Name
1160.64.6002 Boehringer Ingelheim Investigational Site
City
Red Deer
State/Province
Alberta
Country
Canada
Facility Name
1160.64.6012 Boehringer Ingelheim Investigational Site
City
Ajax
State/Province
Ontario
Country
Canada
Facility Name
1160.64.6003 Boehringer Ingelheim Investigational Site
City
Belleville
State/Province
Ontario
Country
Canada
Facility Name
1160.64.6004 Boehringer Ingelheim Investigational Site
City
Cambridge
State/Province
Ontario
Country
Canada
Facility Name
1160.64.6008 Boehringer Ingelheim Investigational Site
City
Kitchener
State/Province
Ontario
Country
Canada
Facility Name
1160.64.6011 Boehringer Ingelheim Investigational Site
City
Oshawa
State/Province
Ontario
Country
Canada
Facility Name
1160.64.6005 Boehringer Ingelheim Investigational Site
City
Sarnia
State/Province
Ontario
Country
Canada
Facility Name
1160.64.6007 Boehringer Ingelheim Investigational Site
City
Stratford
State/Province
Ontario
Country
Canada
Facility Name
1160.64.6013 Boehringer Ingelheim Investigational Site
City
Windsor
State/Province
Ontario
Country
Canada
Facility Name
1160.64.7004 Boehringer Ingelheim Investigational Site
City
Chomutov
Country
Czech Republic
Facility Name
1160.64.7005 Boehringer Ingelheim Investigational Site
City
Jihlava
Country
Czech Republic
Facility Name
1160.64.7003 Boehringer Ingelheim Investigational Site
City
Kolin
Country
Czech Republic
Facility Name
1160.64.7001 Boehringer Ingelheim Investigational Site
City
Plzen
Country
Czech Republic
Facility Name
1160.64.7002 Boehringer Ingelheim Investigational Site
City
Prague 8
Country
Czech Republic
Facility Name
1160.64.8004 Boehringer Ingelheim Investigational Site
City
Frederiksberg
Country
Denmark
Facility Name
1160.64.8003 Boehringer Ingelheim Investigational Site
City
Herlev
Country
Denmark
Facility Name
1160.64.8001 Boehringer Ingelheim Investigational Site
City
Hørsholm
Country
Denmark
Facility Name
1160.64.8002 Boehringer Ingelheim Investigational Site
City
Silkeborg
Country
Denmark
Facility Name
1160.64.9002 Boehringer Ingelheim Investigational Site
City
Jyväskylä
Country
Finland
Facility Name
1160.64.9001 Boehringer Ingelheim Investigational Site
City
Oulu
Country
Finland
Facility Name
1160.64.9003 Boehringer Ingelheim Investigational Site
City
Tampere
Country
Finland
Facility Name
1160.64.1104 Boehringer Ingelheim Investigational Site
City
Garmisch-Partenkirchen
Country
Germany
Facility Name
1160.64.1101 Boehringer Ingelheim Investigational Site
City
Mainz
Country
Germany
Facility Name
1160.64.1103 Boehringer Ingelheim Investigational Site
City
Markgröningen
Country
Germany
Facility Name
1160.64.1102 Boehringer Ingelheim Investigational Site
City
Rheinfelden
Country
Germany
Facility Name
1160.64.1201 Boehringer Ingelheim Investigational Site
City
Gyula
Country
Hungary
Facility Name
1160.64.1203 Boehringer Ingelheim Investigational Site
City
Kecskemét
Country
Hungary
Facility Name
1160.64.1202 Boehringer Ingelheim Investigational Site
City
Szeged
Country
Hungary
Facility Name
1160.64.1204 Boehringer Ingelheim Investigational Site
City
Székesfehérvár
Country
Hungary
Facility Name
1160.64.9105 Boehringer Ingelheim Investigational Site
City
Ahmedabad
Country
India
Facility Name
1160.64.9112 Boehringer Ingelheim Investigational Site
City
Andhra Pradesh
Country
India
Facility Name
1160.64.9109 Boehringer Ingelheim Investigational Site
City
Andhra Predesh
Country
India
Facility Name
1160.64.9103 Boehringer Ingelheim Investigational Site
City
Bangalore
Country
India
Facility Name
1160.64.9108 Boehringer Ingelheim Investigational Site
City
Bangalore
Country
India
Facility Name
1160.64.9107 Boehringer Ingelheim Investigational Site
City
Baroda
Country
India
Facility Name
1160.64.9110 Boehringer Ingelheim Investigational Site
City
Mangalore
Country
India
Facility Name
1160.64.9104 Boehringer Ingelheim Investigational Site
City
Mohali
Country
India
Facility Name
1160.64.9111 Boehringer Ingelheim Investigational Site
City
New Delhi
Country
India
Facility Name
1160.64.9106 Boehringer Ingelheim Investigational Site
City
Pune
Country
India
Facility Name
1160.64.9101 Boehringer Ingelheim Investigational Site
City
Ramdaspeth Nagpur
Country
India
Facility Name
1160.64.9102 Boehringer Ingelheim Investigational Site
City
Secunderabad
Country
India
Facility Name
1160.64.9113 Boehringer Ingelheim Investigational Site
City
Vadodara
Country
India
Facility Name
1160.64.1401 Boehringer Ingelheim Investigational Site
City
Bologna
Country
Italy
Facility Name
1160.64.1405 Boehringer Ingelheim Investigational Site
City
Parma
Country
Italy
Facility Name
1160.64.1402 Boehringer Ingelheim Investigational Site
City
Pavia
Country
Italy
Facility Name
1160.64.1407 Boehringer Ingelheim Investigational Site
City
Reggio Emilia
Country
Italy
Facility Name
1160.64.1403 Boehringer Ingelheim Investigational Site
City
Roma
Country
Italy
Facility Name
1160.64.1404 Boehringer Ingelheim Investigational Site
City
Torino
Country
Italy
Facility Name
1160.64.1503 Boehringer Ingelheim Investigational Site
City
Amsterdam
Country
Netherlands
Facility Name
1160.64.1507 Boehringer Ingelheim Investigational Site
City
Amsterdam
Country
Netherlands
Facility Name
1160.64.1501 Boehringer Ingelheim Investigational Site
City
Hilversum
Country
Netherlands
Facility Name
1160.64.1506 Boehringer Ingelheim Investigational Site
City
Hoofddorp
Country
Netherlands
Facility Name
1160.64.1510 Boehringer Ingelheim Investigational Site
City
Leiden
Country
Netherlands
Facility Name
1160.64.1505 Boehringer Ingelheim Investigational Site
City
Sittard
Country
Netherlands
Facility Name
1160.64.1508 Boehringer Ingelheim Investigational Site
City
Zwolle
Country
Netherlands
Facility Name
1160.64.3001 Boehringer Ingelheim Investigational Site
City
Takapuna Auckland
Country
New Zealand
Facility Name
1160.64.1601 Boehringer Ingelheim Investigational Site
City
Bodø
Country
Norway
Facility Name
1160.64.1606 Boehringer Ingelheim Investigational Site
City
Elverum
Country
Norway
Facility Name
1160.64.1604 Boehringer Ingelheim Investigational Site
City
Lillehammer
Country
Norway
Facility Name
1160.64.1605 Boehringer Ingelheim Investigational Site
City
Tynset
Country
Norway
Facility Name
1160.64.1603 Boehringer Ingelheim Investigational Site
City
Ålesund
Country
Norway
Facility Name
1160.64.1702 Boehringer Ingelheim Investigational Site
City
Krakow
Country
Poland
Facility Name
1160.64.1704 Boehringer Ingelheim Investigational Site
City
Krakow
Country
Poland
Facility Name
1160.64.1705 Boehringer Ingelheim Investigational Site
City
Lodz
Country
Poland
Facility Name
1160.64.1703 Boehringer Ingelheim Investigational Site
City
Piekary Slaskie
Country
Poland
Facility Name
1160.64.1701 Boehringer Ingelheim Investigational Site
City
Warsaw
Country
Poland
Facility Name
1160.64.1801 Boehringer Ingelheim Investigational Site
City
Bryanston
Country
South Africa
Facility Name
1160.64.1804 Boehringer Ingelheim Investigational Site
City
Cape Western Province
Country
South Africa
Facility Name
1160.64.1802 Boehringer Ingelheim Investigational Site
City
Plumstead
Country
South Africa
Facility Name
1160.64.1904 Boehringer Ingelheim Investigational Site
City
Alcorcón (Madrid)
Country
Spain
Facility Name
1160.64.1906 Boehringer Ingelheim Investigational Site
City
Barcelona
Country
Spain
Facility Name
1160.64.1908 Boehringer Ingelheim Investigational Site
City
Fuenlabrada
Country
Spain
Facility Name
1160.64.1901 Boehringer Ingelheim Investigational Site
City
Madrid
Country
Spain
Facility Name
1160.64.1907 Boehringer Ingelheim Investigational Site
City
Madrid
Country
Spain
Facility Name
1160.64.1905 Boehringer Ingelheim Investigational Site
City
Valencia
Country
Spain
Facility Name
1160.64.2101 Boehringer Ingelheim Investigational Site
City
Göteborg
Country
Sweden
Facility Name
1160.64.2112 Boehringer Ingelheim Investigational Site
City
Halmstad
Country
Sweden
Facility Name
1160.64.2105 Boehringer Ingelheim Investigational Site
City
Hässleholm
Country
Sweden
Facility Name
1160.64.2109 Boehringer Ingelheim Investigational Site
City
Kalmar
Country
Sweden
Facility Name
1160.64.2103 Boehringer Ingelheim Investigational Site
City
Kungälv
Country
Sweden
Facility Name
1160.64.2106 Boehringer Ingelheim Investigational Site
City
Lidköping
Country
Sweden
Facility Name
1160.64.2102 Boehringer Ingelheim Investigational Site
City
Motala
Country
Sweden
Facility Name
1160.64.2108 Boehringer Ingelheim Investigational Site
City
Stockholm
Country
Sweden
Facility Name
1160.64.2111 Boehringer Ingelheim Investigational Site
City
Uppsala
Country
Sweden
Facility Name
1160.64.2107 Boehringer Ingelheim Investigational Site
City
Varberg
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
26578849
Citation
Eriksson BI, Dahl OE, Rosencher N, Clemens A, Hantel S, Feuring M, Kreuzer J, Huo M, Friedman RJ. Oral dabigatran etexilate versus enoxaparin for venous thromboembolism prevention after total hip arthroplasty: pooled analysis of two phase 3 randomized trials. Thromb J. 2015 Nov 17;13:36. doi: 10.1186/s12959-015-0067-8. eCollection 2015.
Results Reference
derived
PubMed Identifier
21225098
Citation
Eriksson BI, Dahl OE, Huo MH, Kurth AA, Hantel S, Hermansson K, Schnee JM, Friedman RJ; RE-NOVATE II Study Group. Oral dabigatran versus enoxaparin for thromboprophylaxis after primary total hip arthroplasty (RE-NOVATE II*). A randomised, double-blind, non-inferiority trial. Thromb Haemost. 2011 Apr;105(4):721-9. doi: 10.1160/TH10-10-0679. Epub 2011 Jan 12.
Results Reference
derived
Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1160/1160.64_U10-1392-04.pdf
Description
Related Info
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1160/1160.64_literature.pdf
Description
Related Info

Learn more about this trial

Dabigatran Etexilate Compared With Enoxaparin in Prevention of Venous Thromboembolism (VTE) Following Total Hip Arthroplasty

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