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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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
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)
Secondary ID [1] 0 0
2004-001988-21
Secondary ID [2] 0 0
1160.48
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Thromboembolism 0 0
Arthroplasty, Replacement, Hip 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Blood 0 0 0 0
Clotting disorders

Intervention/exposure
Study type
Interventional
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

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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 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.
Timepoint [1] 0 0
First administration until 31-38 days
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
First administration until 31-38 days
Secondary outcome [2] 0 0
Proximal Deep Vein Thrombosis During Treatment Period - Proximal Deep Vein Thrombosis as adjudicated by the VTE events committee
Timepoint [2] 0 0
First administration until 31-38 days
Secondary outcome [3] 0 0
Total Deep Vein Thrombosis During Treatment Period - Total Deep Vein Thrombosis as adjudicated by the VTE events committee
Timepoint [3] 0 0
First administration until 31-38 days
Secondary outcome [4] 0 0
Symptomatic Deep Vein Thrombosis During Treatment Period - Symptomatic Deep Vein Thrombosis, confirmed by venous compression ultrasound, venography or autopsy, and as adjudicated by the VTE events committee
Timepoint [4] 0 0
First administration until 31-38 days
Secondary outcome [5] 0 0
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
Timepoint [5] 0 0
First administration until 31-38 days
Secondary outcome [6] 0 0
Death During Treatment Period - All cause death, as adjudicated by the VTE events committee
Timepoint [6] 0 0
First administration until 31-38 days
Secondary outcome [7] 0 0
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 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).
Timepoint [7] 0 0
end of treatment to day 91±7
Secondary outcome [8] 0 0
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 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.
Timepoint [8] 0 0
First administration until 31-38 days
Secondary outcome [9] 0 0
Blood Transfusion - Blood transfusion for treated and operated patients on Day of surgery.
Timepoint [9] 0 0
Day 1
Secondary outcome [10] 0 0
Volume of Blood Loss - Volume of blood loss for treated and operated patients during surgery.
Timepoint [10] 0 0
Day 1
Secondary outcome [11] 0 0
Laboratory Analyses - Frequency of patients with possible clinically significant abnormalities.
Timepoint [11] 0 0
First administration to end of study

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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
1160.48.06108 Canberra Hospital - Garren
Recruitment hospital [2] 0 0
1160.48.06106 St George Public Hospital - Kogarah
Recruitment hospital [3] 0 0
1160.48.06110 Suite 13 level 4 - Lismore
Recruitment hospital [4] 0 0
1160.48.06105 Flinders Medical Centre - Bedford Park
Recruitment hospital [5] 0 0
1160.48.06104 Ecru - Box Hill
Recruitment hospital [6] 0 0
1160.48.06102 Monash Medical Centre - Clayton
Recruitment hospital [7] 0 0
1160.48.06101 Emeritus Research - Malvern
Recruitment hospital [8] 0 0
1160.48.06103 Maroondah Hospital - Ringwood East
Recruitment hospital [9] 0 0
1160.48.06113 - Windsor
Recruitment hospital [10] 0 0
1160.48.06111 Haemophillia & Thrombosis Service - Perth
Recruitment postcode(s) [1] 0 0
- Garren
Recruitment postcode(s) [2] 0 0
- Kogarah
Recruitment postcode(s) [3] 0 0
- Lismore
Recruitment postcode(s) [4] 0 0
- Bedford Park
Recruitment postcode(s) [5] 0 0
- Box Hill
Recruitment postcode(s) [6] 0 0
- Clayton
Recruitment postcode(s) [7] 0 0
- Malvern
Recruitment postcode(s) [8] 0 0
- Ringwood East
Recruitment postcode(s) [9] 0 0
- Windsor
Recruitment postcode(s) [10] 0 0
- Perth
Recruitment outside Australia
Country [1] 0 0
Austria
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Linz
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Austria
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Wels
Country [3] 0 0
Austria
State/province [3] 0 0
Wien
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Austria
State/province [4] 0 0
Wr. Neustadt
Country [5] 0 0
Belgium
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Brussels
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Belgium
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Gent
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Belgium
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Hasselt
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Belgium
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Herentals
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Lanaken
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Leuven
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Brno-Bohunice
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Czech Republic
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Chomutov
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Czech Republic
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Havlickuv Brod
Country [14] 0 0
Czech Republic
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Jihlava
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Czech Republic
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Kladno
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Czech Republic
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Kolin
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Czech Republic
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Ostrava
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Plzen
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Pradubice
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Prague 8
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Hellerup
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Hørsholm
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København NV
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Denmark
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København S
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Silkeborg
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Finland
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Helsinki
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Jyväskylä
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Oulu
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Seinäjoki
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Tampere
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Amiens cedex 1
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Erlangen
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Frankfurt
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Kamp-Lintfort
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Wiesbaden
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Hilversum
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Nijmegen
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Sittard
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Bodø
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Mielec
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Alcorcón (Madrid)
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Barcelona
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Hospitalet (Barcelona)
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Jaén
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Madrid
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Móstoles (Madrid)
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Valencia
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Sweden
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Falköping
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Göteborg
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Halmstad
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Kalmar
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Kungälv
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Lidköping
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Linköping
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Mölndal
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Stockholm
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Sweden
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Varberg

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Boehringer Ingelheim
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT00168818
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Boehringer Ingelheim
Address 0 0
Boehringer Ingelheim
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications