Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00168818
Registration number
NCT00168818
Ethics application status
Date submitted
12/09/2005
Date registered
15/09/2005
Date last updated
19/05/2014
Titles & IDs
Public title
Dabigatran Etexilate in Extended Venous Thromboembolism (VTE) Prevention After Hip Replacement Surgery
Query!
Scientific title
A Phase III Randomised, Parallel Group, Double-blind, Active Controlled Study to Investigate the Efficacy and Safety of Two Different Dose Regimens of Orally Administered Dabigatran Etexilate Capsules [150 or 220 mg Once Daily Starting With Half Dose (75 or 110 mg) on the Day of Surgery] Compared to Subcutaneous Enoxaparin 40 mg Once Daily for 28-35 Days, in Prevention of Venous Thromboembolism in Patients With Primary Elective Total Hip Replacement Surgery. RE-NOVATE (Extended Thromboembolism Prevention After Hip Surgery)
Query!
Secondary ID [1]
0
0
2004-001988-21
Query!
Secondary ID [2]
0
0
1160.48
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Thromboembolism
0
0
Query!
Arthroplasty, Replacement, Hip
0
0
Query!
Condition category
Condition code
Cardiovascular
0
0
0
0
Query!
Diseases of the vasculature and circulation including the lymphatic system
Query!
Blood
0
0
0
0
Query!
Clotting disorders
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - dabigatran etexilate
Treatment: Drugs - dabigatran etexilate
Treatment: Drugs - enoxaparin
Experimental: dabigatran etexilate 75 mg - daily dose 150 mg once daily, half a dose on the day of surgery
Experimental: dabigatran etexilate 110 mg - daily dose 220 mg once daily, half a dose on the day of surgery
Active Comparator: enoxaparin - 40 mg once daily
Treatment: Drugs: dabigatran etexilate
daily dose 150 mg once daily, half a dose on the day of surgery
Treatment: Drugs: dabigatran etexilate
daily dose 150 mg once daily, half a dose on the day of surgery
Treatment: Drugs: enoxaparin
40 mg once daily
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period
Query!
Assessment method [1]
0
0
Total Venous Thromboembolic Event (VTE) includes both proximal and distal deep vein thrombosis (DVT) (detected by routine bilateral venography), symptomatic DVT (confirmed by venous compression 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.
Query!
Timepoint [1]
0
0
First administration until 31-38 days
Query!
Secondary outcome [1]
0
0
Major Venous Thromboembolic Event and Venous Thromboembolic Event-related Mortality During Treatment Period
Query!
Assessment method [1]
0
0
Major Venous Thromboembolic Event (VTE) is defined as proximal DVT and PE, as adjudicated by the VTE events committee
Query!
Timepoint [1]
0
0
First administration until 31-38 days
Query!
Secondary outcome [2]
0
0
Proximal Deep Vein Thrombosis During Treatment Period
Query!
Assessment method [2]
0
0
Proximal Deep Vein Thrombosis as adjudicated by the VTE events committee
Query!
Timepoint [2]
0
0
First administration until 31-38 days
Query!
Secondary outcome [3]
0
0
Total Deep Vein Thrombosis During Treatment Period
Query!
Assessment method [3]
0
0
Total Deep Vein Thrombosis as adjudicated by the VTE events committee
Query!
Timepoint [3]
0
0
First administration until 31-38 days
Query!
Secondary outcome [4]
0
0
Symptomatic Deep Vein Thrombosis During Treatment Period
Query!
Assessment method [4]
0
0
Symptomatic Deep Vein Thrombosis, confirmed by venous compression ultrasound, venography or autopsy, and as adjudicated by the VTE events committee
Query!
Timepoint [4]
0
0
First administration until 31-38 days
Query!
Secondary outcome [5]
0
0
Pulmonary Embolism During Treatment Period
Query!
Assessment method [5]
0
0
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
Query!
Timepoint [5]
0
0
First administration until 31-38 days
Query!
Secondary outcome [6]
0
0
Death During Treatment Period
Query!
Assessment method [6]
0
0
All cause death, as adjudicated by the VTE events committee
Query!
Timepoint [6]
0
0
First administration until 31-38 days
Query!
Secondary outcome [7]
0
0
Total Venous Thromboembolic Event (VTE) and All-cause Mortality During the Follow-up Period
Query!
Assessment method [7]
0
0
Total Venous Thromboembolic Event (VTE) includes both proximal and distal deep vein thrombosis (DVT) (detected by routine bilateral venography), symptomatic DVT (confirmed by venous compression ultrasound, venography or autopsy) and pulmonary embolism (PE) (confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy).
Query!
Timepoint [7]
0
0
end of treatment to day 91±7
Query!
Secondary outcome [8]
0
0
Number of Participants With Bleeding Events (Defined According to Modified McMaster Criteria) During Treatment Period
Query!
Assessment method [8]
0
0
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 greater than or equal to 25 cm²
wound hematoma greater than or equal to 100 cm²
spontaneous nose bleed lasting longer than 5 min
macroscopic hematuria spontaneous or lasting longer than 24 hours if associated with an intervention
spontaneous rectal bleeding (more than a spot on toilet paper)
gingival bleeding lasting longer than 5 min
any other bleeding event considered clinically relevant by the investigator
Minor bleeding events were defined as all other bleeding events that did not fulfil the criteria from above.
Query!
Timepoint [8]
0
0
First administration until 31-38 days
Query!
Secondary outcome [9]
0
0
Blood Transfusion
Query!
Assessment method [9]
0
0
Blood transfusion for treated and operated patients on Day of surgery.
Query!
Timepoint [9]
0
0
Day 1
Query!
Secondary outcome [10]
0
0
Volume of Blood Loss
Query!
Assessment method [10]
0
0
Volume of blood loss for treated and operated patients during surgery.
Query!
Timepoint [10]
0
0
Day 1
Query!
Secondary outcome [11]
0
0
Laboratory Analyses
Query!
Assessment method [11]
0
0
Frequency of patients with possible clinically significant abnormalities.
Query!
Timepoint [11]
0
0
First administration to end of study
Query!
Eligibility
Key inclusion criteria
Inclusion criteria
Inclusion criteria (selected):
- Patients (18 years or older) scheduled to undergo a primary, unilateral, elective
total hip replacement
- Written Informed Consent
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
Exclusion criteria
Exclusion criteria (selected):
- Patients with an excessive risk of bleeding, for example because of history of
bleeding diathesis major surgery or trauma within the last 3 months history of
haemorrhagic stroke or any of the following intracranial pathologies: bleeding,
neoplasm, AV malformation or aneurysm clinically relevant bleeding or gastric /
duodenal ulcer within the last 6 months treatment with anticoagulants within 7 days
prior to joint replacement surgery or anticipated need during the study treatment
period thrombocytopenia.
- Active malignant disease or current cytostatic treatment
- Known severe renal insufficiency
- Liver disease expected to have any potential impact on survival, or elevated AST or
ALT > 2x upper limit of normal
- Recent unstable cardiovascular disease or history of myocardial infarction within the
last 3 months
- Pre-menopausal women who are pregnant or nursing, or are of child-bearing potential
and are not practising or do not plan to continue practising acceptable methods of
birth control
- Allergy to radio opaque contrast media or iodine, heparins (incl. heparin induced
thrombocytopenia) or dabigatran
- Contraindications to enoxaparin
- Participation in a clinical trial during the last 30 days
Query!
Study design
Purpose of the study
Prevention
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/11/2004
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
3494
Query!
Recruitment in Australia
Recruitment state(s)
ACT,NSW,SA,VIC,WA
Query!
Recruitment hospital [1]
0
0
1160.48.06108 Canberra Hospital - Garren
Query!
Recruitment hospital [2]
0
0
1160.48.06106 St George Public Hospital - Kogarah
Query!
Recruitment hospital [3]
0
0
1160.48.06110 Suite 13 level 4 - Lismore
Query!
Recruitment hospital [4]
0
0
1160.48.06105 Flinders Medical Centre - Bedford Park
Query!
Recruitment hospital [5]
0
0
1160.48.06104 Ecru - Box Hill
Query!
Recruitment hospital [6]
0
0
1160.48.06102 Monash Medical Centre - Clayton
Query!
Recruitment hospital [7]
0
0
1160.48.06101 Emeritus Research - Malvern
Query!
Recruitment hospital [8]
0
0
1160.48.06103 Maroondah Hospital - Ringwood East
Query!
Recruitment hospital [9]
0
0
1160.48.06113 - Windsor
Query!
Recruitment hospital [10]
0
0
1160.48.06111 Haemophillia & Thrombosis Service - Perth
Query!
Recruitment postcode(s) [1]
0
0
- Garren
Query!
Recruitment postcode(s) [2]
0
0
- Kogarah
Query!
Recruitment postcode(s) [3]
0
0
- Lismore
Query!
Recruitment postcode(s) [4]
0
0
- Bedford Park
Query!
Recruitment postcode(s) [5]
0
0
- Box Hill
Query!
Recruitment postcode(s) [6]
0
0
- Clayton
Query!
Recruitment postcode(s) [7]
0
0
- Malvern
Query!
Recruitment postcode(s) [8]
0
0
- Ringwood East
Query!
Recruitment postcode(s) [9]
0
0
- Windsor
Query!
Recruitment postcode(s) [10]
0
0
- Perth
Query!
Recruitment outside Australia
Country [1]
0
0
Austria
Query!
State/province [1]
0
0
Linz
Query!
Country [2]
0
0
Austria
Query!
State/province [2]
0
0
Wels
Query!
Country [3]
0
0
Austria
Query!
State/province [3]
0
0
Wien
Query!
Country [4]
0
0
Austria
Query!
State/province [4]
0
0
Wr. Neustadt
Query!
Country [5]
0
0
Belgium
Query!
State/province [5]
0
0
Brussels
Query!
Country [6]
0
0
Belgium
Query!
State/province [6]
0
0
Gent
Query!
Country [7]
0
0
Belgium
Query!
State/province [7]
0
0
Hasselt
Query!
Country [8]
0
0
Belgium
Query!
State/province [8]
0
0
Herentals
Query!
Country [9]
0
0
Belgium
Query!
State/province [9]
0
0
Lanaken
Query!
Country [10]
0
0
Belgium
Query!
State/province [10]
0
0
Leuven
Query!
Country [11]
0
0
Czech Republic
Query!
State/province [11]
0
0
Brno-Bohunice
Query!
Country [12]
0
0
Czech Republic
Query!
State/province [12]
0
0
Chomutov
Query!
Country [13]
0
0
Czech Republic
Query!
State/province [13]
0
0
Havlickuv Brod
Query!
Country [14]
0
0
Czech Republic
Query!
State/province [14]
0
0
Jihlava
Query!
Country [15]
0
0
Czech Republic
Query!
State/province [15]
0
0
Kladno
Query!
Country [16]
0
0
Czech Republic
Query!
State/province [16]
0
0
Kolin
Query!
Country [17]
0
0
Czech Republic
Query!
State/province [17]
0
0
Ostrava
Query!
Country [18]
0
0
Czech Republic
Query!
State/province [18]
0
0
Plzen
Query!
Country [19]
0
0
Czech Republic
Query!
State/province [19]
0
0
Pradubice
Query!
Country [20]
0
0
Czech Republic
Query!
State/province [20]
0
0
Prague 8
Query!
Country [21]
0
0
Denmark
Query!
State/province [21]
0
0
Hellerup
Query!
Country [22]
0
0
Denmark
Query!
State/province [22]
0
0
Hørsholm
Query!
Country [23]
0
0
Denmark
Query!
State/province [23]
0
0
København NV
Query!
Country [24]
0
0
Denmark
Query!
State/province [24]
0
0
København S
Query!
Country [25]
0
0
Denmark
Query!
State/province [25]
0
0
Silkeborg
Query!
Country [26]
0
0
Finland
Query!
State/province [26]
0
0
Helsinki
Query!
Country [27]
0
0
Finland
Query!
State/province [27]
0
0
Jyväskylä
Query!
Country [28]
0
0
Finland
Query!
State/province [28]
0
0
Oulu
Query!
Country [29]
0
0
Finland
Query!
State/province [29]
0
0
Seinäjoki
Query!
Country [30]
0
0
Finland
Query!
State/province [30]
0
0
Tampere
Query!
Country [31]
0
0
France
Query!
State/province [31]
0
0
Amiens cedex 1
Query!
Country [32]
0
0
France
Query!
State/province [32]
0
0
Roubaix cedex
Query!
Country [33]
0
0
France
Query!
State/province [33]
0
0
Soyaux
Query!
Country [34]
0
0
France
Query!
State/province [34]
0
0
Strasbourg
Query!
Country [35]
0
0
Germany
Query!
State/province [35]
0
0
Bad Mergentheim
Query!
Country [36]
0
0
Germany
Query!
State/province [36]
0
0
Erlangen
Query!
Country [37]
0
0
Germany
Query!
State/province [37]
0
0
Frankfurt
Query!
Country [38]
0
0
Germany
Query!
State/province [38]
0
0
Garmisch-Partenkirchen
Query!
Country [39]
0
0
Germany
Query!
State/province [39]
0
0
Kamp-Lintfort
Query!
Country [40]
0
0
Germany
Query!
State/province [40]
0
0
Mainz
Query!
Country [41]
0
0
Germany
Query!
State/province [41]
0
0
Markgröningen
Query!
Country [42]
0
0
Germany
Query!
State/province [42]
0
0
Rheinfelden
Query!
Country [43]
0
0
Germany
Query!
State/province [43]
0
0
Schwandorf
Query!
Country [44]
0
0
Germany
Query!
State/province [44]
0
0
Sommerfeld
Query!
Country [45]
0
0
Germany
Query!
State/province [45]
0
0
Wiesbaden
Query!
Country [46]
0
0
Hungary
Query!
State/province [46]
0
0
Budapest
Query!
Country [47]
0
0
Hungary
Query!
State/province [47]
0
0
Békéscsaba
Query!
Country [48]
0
0
Hungary
Query!
State/province [48]
0
0
Gyula
Query!
Country [49]
0
0
Hungary
Query!
State/province [49]
0
0
Kecskemét
Query!
Country [50]
0
0
Hungary
Query!
State/province [50]
0
0
Szeged
Query!
Country [51]
0
0
Hungary
Query!
State/province [51]
0
0
Székesfehérvár
Query!
Country [52]
0
0
Italy
Query!
State/province [52]
0
0
Bergamo
Query!
Country [53]
0
0
Italy
Query!
State/province [53]
0
0
Bologna
Query!
Country [54]
0
0
Italy
Query!
State/province [54]
0
0
Milano
Query!
Country [55]
0
0
Italy
Query!
State/province [55]
0
0
Pavia
Query!
Country [56]
0
0
Netherlands
Query!
State/province [56]
0
0
Amsterdam
Query!
Country [57]
0
0
Netherlands
Query!
State/province [57]
0
0
Heemstede
Query!
Country [58]
0
0
Netherlands
Query!
State/province [58]
0
0
Helmond
Query!
Country [59]
0
0
Netherlands
Query!
State/province [59]
0
0
Hilversum
Query!
Country [60]
0
0
Netherlands
Query!
State/province [60]
0
0
Nijmegen
Query!
Country [61]
0
0
Netherlands
Query!
State/province [61]
0
0
Sittard
Query!
Country [62]
0
0
Norway
Query!
State/province [62]
0
0
Bodø
Query!
Country [63]
0
0
Norway
Query!
State/province [63]
0
0
Bærum Postterminal
Query!
Country [64]
0
0
Norway
Query!
State/province [64]
0
0
Elverum
Query!
Country [65]
0
0
Norway
Query!
State/province [65]
0
0
Skien
Query!
Country [66]
0
0
Norway
Query!
State/province [66]
0
0
Ålesund
Query!
Country [67]
0
0
Poland
Query!
State/province [67]
0
0
Bialystok
Query!
Country [68]
0
0
Poland
Query!
State/province [68]
0
0
Kielce
Query!
Country [69]
0
0
Poland
Query!
State/province [69]
0
0
Krakow
Query!
Country [70]
0
0
Poland
Query!
State/province [70]
0
0
Lodz
Query!
Country [71]
0
0
Poland
Query!
State/province [71]
0
0
Mielec
Query!
Country [72]
0
0
Poland
Query!
State/province [72]
0
0
Piekary Slaskie
Query!
Country [73]
0
0
Poland
Query!
State/province [73]
0
0
Rzeszow
Query!
Country [74]
0
0
Poland
Query!
State/province [74]
0
0
Warsaw
Query!
Country [75]
0
0
South Africa
Query!
State/province [75]
0
0
Bryanston
Query!
Country [76]
0
0
South Africa
Query!
State/province [76]
0
0
Johannesburg
Query!
Country [77]
0
0
South Africa
Query!
State/province [77]
0
0
Randburg
Query!
Country [78]
0
0
South Africa
Query!
State/province [78]
0
0
Sandton
Query!
Country [79]
0
0
Spain
Query!
State/province [79]
0
0
Alcorcón (Madrid)
Query!
Country [80]
0
0
Spain
Query!
State/province [80]
0
0
Barcelona
Query!
Country [81]
0
0
Spain
Query!
State/province [81]
0
0
Hospitalet (Barcelona)
Query!
Country [82]
0
0
Spain
Query!
State/province [82]
0
0
Jaén
Query!
Country [83]
0
0
Spain
Query!
State/province [83]
0
0
Madrid
Query!
Country [84]
0
0
Spain
Query!
State/province [84]
0
0
Móstoles (Madrid)
Query!
Country [85]
0
0
Spain
Query!
State/province [85]
0
0
Valencia
Query!
Country [86]
0
0
Sweden
Query!
State/province [86]
0
0
Falköping
Query!
Country [87]
0
0
Sweden
Query!
State/province [87]
0
0
Göteborg
Query!
Country [88]
0
0
Sweden
Query!
State/province [88]
0
0
Halmstad
Query!
Country [89]
0
0
Sweden
Query!
State/province [89]
0
0
Kalmar
Query!
Country [90]
0
0
Sweden
Query!
State/province [90]
0
0
Kungälv
Query!
Country [91]
0
0
Sweden
Query!
State/province [91]
0
0
Lidköping
Query!
Country [92]
0
0
Sweden
Query!
State/province [92]
0
0
Linköping
Query!
Country [93]
0
0
Sweden
Query!
State/province [93]
0
0
Mölndal
Query!
Country [94]
0
0
Sweden
Query!
State/province [94]
0
0
Stockholm
Query!
Country [95]
0
0
Sweden
Query!
State/province [95]
0
0
Varberg
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Boehringer Ingelheim
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
The objective of this study is to determine the comparative efficacy and safety of two oral
regimens of dabigatran etexilate, compared to a standard subcutaneous regimen of enoxaparin,
in prevention of venous thromboembolism in patients with primary elective total hip
replacement surgery.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT00168818
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Boehringer Ingelheim
Query!
Address
0
0
Boehringer Ingelheim
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00168818
Download to PDF