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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00657150
Registration number
NCT00657150
Ethics application status
Date submitted
27/03/2008
Date registered
14/04/2008
Date last updated
2/07/2014
Titles & IDs
Public title
Dabigatran Etexilate Compared With Enoxaparin in Prevention of Venous Thromboembolism (VTE) Following Total Hip Arthroplasty
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Scientific 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)
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Secondary ID [1]
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2007-002630-11
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Secondary ID [2]
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1160.64
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Venous Thromboembolism
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Condition category
Condition code
Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Blood
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Clotting disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Enoxaparin
Treatment: Drugs - Dabigatran etexilate
Experimental: Dabigatran etexilate - 220 mg once daily
Active comparator: Enoxaparin - 40 mg once daily
Treatment: Drugs: Enoxaparin
40 mg once daily
Treatment: Drugs: Dabigatran etexilate
220 mg once daily
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants With Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period
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Assessment method [1]
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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.
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Timepoint [1]
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28-35 days
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Secondary outcome [1]
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Number of Participants With Major Venous Thromboembolic Event and Venous Thromboembolic Event-related Mortality During Treatment Period
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Assessment method [1]
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Major Venous Thromboembolic Event (VTE) is defined as proximal DVT and PE, as adjudicated by the VTE events committee
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Timepoint [1]
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28-35 days
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Secondary outcome [2]
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Number of Participants With Proximal Deep Vein Thrombosis During Treatment Period
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Assessment method [2]
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Proximal Deep Vein Thrombosis as adjudicated by the VTE events committee
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Timepoint [2]
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28-35 days
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Secondary outcome [3]
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Number of Participants With Total Deep Vein Thrombosis During Treatment Period
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Assessment method [3]
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Total Deep Vein Thrombosis as adjudicated by the VTE events committee
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Timepoint [3]
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28-35 days
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Secondary outcome [4]
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Number of Participants With Symptomatic Deep Vein Thrombosis During Treatment Period
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Assessment method [4]
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Symptomatic Deep Vein Thrombosis, confirmed by venous duplex, ultrasound, venography or autopsy, and as adjudicated by the VTE events committee
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Timepoint [4]
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28-35 days
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Secondary outcome [5]
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Number of Participants With Pulmonary Embolism During Treatment Period
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Assessment method [5]
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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
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Timepoint [5]
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28-35 days
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Secondary outcome [6]
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Number of Participants Who Died During Treatment Period
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Assessment method [6]
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All cause death, as adjudicated by the VTE events committee
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Timepoint [6]
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28-35 days
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Secondary outcome [7]
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Number of Participants With Total Venous Thromboembolic Event (VTE) and All-cause Mortality During the Follow-up Period
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Assessment method [7]
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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).
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Timepoint [7]
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3 months
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Secondary outcome [8]
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Number of Participants With Bleeding Events (Defined According to Modified McMaster Criteria) During Treatment Period
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Assessment method [8]
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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.
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Timepoint [8]
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28-35 days
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Secondary outcome [9]
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Blood Transfusion
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Assessment method [9]
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Number of treated and operated patients with required blood transfusion on day of surgery.
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Timepoint [9]
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Day 1
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Secondary outcome [10]
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Volume of Blood Loss
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Assessment method [10]
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Volume of blood loss for treated and operated patients during surgery.
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Timepoint [10]
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Day 1
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Secondary outcome [11]
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Laboratory Analyses
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Assessment method [11]
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Frequency of patients with possible clinically significant abnormalities.
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Timepoint [11]
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First administration to end of study
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Eligibility
Key inclusion 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/03/2008
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
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Accrual to date
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Final
2055
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Recruitment in Australia
Recruitment state(s)
SA,VIC,WA
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Recruitment hospital [1]
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1160.64.2003 Boehringer Ingelheim Investigational Site - Daws Park
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Recruitment hospital [2]
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1160.64.2002 Boehringer Ingelheim Investigational Site - Box HIll
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Recruitment hospital [3]
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1160.64.2001 Boehringer Ingelheim Investigational Site - Windsor
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Recruitment hospital [4]
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1160.64.2004 Boehringer Ingelheim Investigational Site - Nedlands
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Recruitment postcode(s) [1]
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- Daws Park
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Recruitment postcode(s) [2]
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- Box HIll
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Recruitment postcode(s) [3]
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- Windsor
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Recruitment postcode(s) [4]
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- Nedlands
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Recruitment outside Australia
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United States of America
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California
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Colorado
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Washington
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Austria
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Graz
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Austria
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Linz
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Stockholm
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Uppsala
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Varberg
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Boehringer Ingelheim
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT00657150
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Trial related presentations / publications
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. 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.
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Contacts
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Boehringer Ingelheim
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Boehringer Ingelheim
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What supporting documents are/will be available?
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Results publications and other study-related documents
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Results are available at
https://clinicaltrials.gov/study/NCT00657150
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