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Dabigatran Etexilate in Extended Venous Thromboembolism (VTE) Prevention After Hip Replacement Surgery

Information source: Boehringer Ingelheim
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Thromboembolism; Arthroplasty, Replacement, Hip

Intervention: dabigatran etexilate (Drug); dabigatran etexilate (Drug); enoxaparin (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Boehringer Ingelheim

Official(s) and/or principal investigator(s):
Boehringer Ingelheim, Study Chair, Affiliation: Boehringer Ingelheim

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.

Clinical Details

Official 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)

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Primary outcome: Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period

Secondary outcome:

Major Venous Thromboembolic Event and Venous Thromboembolic Event-related Mortality During Treatment Period

Proximal Deep Vein Thrombosis During Treatment Period

Total Deep Vein Thrombosis During Treatment Period

Symptomatic Deep Vein Thrombosis During Treatment Period

Pulmonary Embolism During Treatment Period

Death During Treatment Period

Total Venous Thromboembolic Event (VTE) and All-cause Mortality During the Follow-up Period

Number of Participants With Bleeding Events (Defined According to Modified McMaster Criteria) During Treatment Period

Blood Transfusion

Volume of Blood Loss

Laboratory Analyses

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion criteria Inclusion criteria (selected):

- Patients (18 years or older) scheduled to undergo a primary, unilateral, elective

total hip replacement

- Written Informed Consent

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

Locations and Contacts

1160.48.04304 Boehringer Ingelheim Investigational Site, Linz, Austria

1160.48.04303 Boehringer Ingelheim Investigational Site, Wels, Austria

1160.48.04302 Boehringer Ingelheim Investigational Site, Wien, Austria

1160.48.04301 Boehringer Ingelheim Investigational Site, Wr. Neustadt, Austria

1160.48.03207 UVC Brugmann, Brussels, Belgium

1160.48.03206 Campus Sint-Lucas, Gent, Belgium

1160.48.03208 UZ Gent, Gent, Belgium

1160.48.03202 Boehringer Ingelheim Investigational Site, Hasselt, Belgium

1160.48.03203 AZ Sint Elisabeth, Herentals, Belgium

1160.48.03205 Ziekenhuis Oost-Limburg, Lanaken, Belgium

1160.48.03201 UZ Gasthuisberg, Leuven, Belgium

1160.48.42004 Boehringer Ingelheim Investigational Site, Brno-Bohunice, Czech Republic

1160.48.42010 Boehringer Ingelheim Investigational Site, Chomutov, Czech Republic

1160.48.42009 Boehringer Ingelheim Investigational Site, Havlickuv Brod, Czech Republic

1160.48.42008 Boehringer Ingelheim Investigational Site, Jihlava, Czech Republic

1160.48.42002 Boehringer Ingelheim Investigational Site, Kladno, Czech Republic

1160.48.42006 Boehringer Ingelheim Investigational Site, Kolin, Czech Republic

1160.48.42003 Boehringer Ingelheim Investigational Site, Ostrava, Czech Republic

1160.48.42001 Boehringer Ingelheim Investigational Site, Plzen, Czech Republic

1160.48.42007 Boehringer Ingelheim Investigational Site, Pradubice, Czech Republic

1160.48.42005 Boehringer Ingelheim Investigational Site, Prague 8, Czech Republic

1160.48.04571 Boehringer Ingelheim Investigational Site, Hellerup, Denmark

1160.48.04570 Boehringer Ingelheim Investigational Site, Hørsholm, Denmark

1160.48.04573 Boehringer Ingelheim Investigational Site, København NV, Denmark

1160.48.04574 Boehringer Ingelheim Investigational Site, København S, Denmark

1160.48.04575 Boehringer Ingelheim Investigational Site, Silkeborg, Denmark

1160.48.35803 Boehringer Ingelheim Investigational Site, Helsinki, Finland

1160.48.35802 Boehringer Ingelheim Investigational Site, Jyväskylä, Finland

1160.48.35801 Boehringer Ingelheim Investigational Site, Oulu, Finland

1160.48.35804 Boehringer Ingelheim Investigational Site, Seinäjoki, Finland

1160.48.35805 Boehringer Ingelheim Investigational Site, Tampere, Finland

1160.48.03304 Boehringer Ingelheim Investigational Site, Amiens cedex 1, France

1160.48.03303 Boehringer Ingelheim Investigational Site, Roubaix cedex, France

1160.48.03302 Boehringer Ingelheim Investigational Site, Soyaux, France

1160.48.03308 Boehringer Ingelheim Investigational Site, Strasbourg, France

1160.48.04906 Caritaskrankenhaus, Bad Mergentheim, Germany

1160.48.04910 F.-A.-Universität Erlangen-Nürnberg, Erlangen, Germany

1160.48.04904 Orthopädische Universitätsklinik, Frankfurt, Germany

1160.48.04902 Klinikum Garmisch-Partenkirchen, Garmisch-Partenkirchen, Germany

1160.48.04914 St. Bernhard-Hospital, Kamp-Lintfort, Germany

1160.48.04907 Johannes Gutenberg-Universität Mainz, Mainz, Germany

1160.48.04912 Orthopädische Klinik Markgröningen gGmbH, Markgröningen, Germany

1160.48.04901 Kreiskrankenhaus, Rheinfelden, Germany

1160.48.04915 Orthopädische Klinik Lindenlohe, Schwandorf, Germany

1160.48.04903 Hellmuth-Ulrici-Kliniken, Sommerfeld, Germany

1160.48.04905 Aukammklinik, Wiesbaden, Germany

1160.48.03603 Boehringer Ingelheim Investigational Site, Budapest, Hungary

1160.48.03606 Boehringer Ingelheim Investigational Site, Budapest, Hungary

1160.48.03607 Boehringer Ingelheim Investigational Site, Békéscsaba, Hungary

1160.48.03601 Boehringer Ingelheim Investigational Site, Gyula, Hungary

1160.48.03604 Boehringer Ingelheim Investigational Site, Kecskemét, Hungary

1160.48.03602 Boehringer Ingelheim Investigational Site, Szeged, Hungary

1160.48.03605 Boehringer Ingelheim Investigational Site, Székesfehérvár, Hungary

1160.48.03903 Boehringer Ingelheim Investigational Site, Bergamo, Italy

1160.48.03904 Boehringer Ingelheim Investigational Site, Bologna, Italy

1160.48.03902 Boehringer Ingelheim Investigational Site, Milano, Italy

1160.48.03901 Boehringer Ingelheim Investigational Site, Pavia, Italy

1160.48.03102 Boehringer Ingelheim Investigational Site, Amsterdam, Netherlands

1160.48.03101 Boehringer Ingelheim Investigational Site, Heemstede, Netherlands

1160.48.03107 Boehringer Ingelheim Investigational Site, Helmond, Netherlands

1160.48.03103 Boehringer Ingelheim Investigational Site, Hilversum, Netherlands

1160.48.03104 Boehringer Ingelheim Investigational Site, Nijmegen, Netherlands

1160.48.03105 Boehringer Ingelheim Investigational Site, Sittard, Netherlands

1160.48.04701 Boehringer Ingelheim Investigational Site, Bodø, Norway

1160.48.04704 Boehringer Ingelheim Investigational Site, Bærum Postterminal, Norway

1160.48.04707 Boehringer Ingelheim Investigational Site, Bærum Postterminal, Norway

1160.48.04706 Boehringer Ingelheim Investigational Site, Elverum, Norway

1160.48.04702 Boehringer Ingelheim Investigational Site, Skien, Norway

1160.48.04703 Boehringer Ingelheim Investigational Site, Ålesund, Norway

1160.48.04810 Boehringer Ingelheim Investigational Site, Bialystok, Poland

1160.48.04804 Boehringer Ingelheim Investigational Site, Kielce, Poland

1160.48.04806 Boehringer Ingelheim Investigational Site, Krakow, Poland

1160.48.04807 Boehringer Ingelheim Investigational Site, Krakow, Poland

1160.48.04812 Boehringer Ingelheim Investigational Site, Krakow, Poland

1160.48.04820 Boehringer Ingelheim Investigational Site, Lodz, Poland

1160.48.04814 Boehringer Ingelheim Investigational Site, Mielec, Poland

1160.48.04808 Boehringer Ingelheim Investigational Site, Piekary Slaskie, Poland

1160.48.04817 Boehringer Ingelheim Investigational Site, Rzeszow, Poland

1160.48.04801 Boehringer Ingelheim Investigational Site, Warsaw, Poland

1160.48.04802 Boehringer Ingelheim Investigational Site, Warsaw, Poland

1160.48.04803 Boehringer Ingelheim Investigational Site, Warsaw, Poland

1160.48.02701 Boehringer Ingelheim Investigational Site, Bryanston, South Africa

1160.48.02704 Boehringer Ingelheim Investigational Site, Johannesburg, South Africa

1160.48.02703 Boehringer Ingelheim Investigational Site, Randburg, South Africa

1160.48.02702 Boehringer Ingelheim Investigational Site, Sandton, South Africa

1160.48.03405 Boehringer Ingelheim Investigational Site, Alcorcón (Madrid), Spain

1160.48.03403 Boehringer Ingelheim Investigational Site, Barcelona, Spain

1160.48.03411 Boehringer Ingelheim Investigational Site, Barcelona, Spain

1160.48.03407 Boehringer Ingelheim Investigational Site, Hospitalet (Barcelona), Spain

1160.48.03409 Boehringer Ingelheim Investigational Site, Jaén, Spain

1160.48.03401 Boehringer Ingelheim Investigational Site, Madrid, Spain

1160.48.03402 Boehringer Ingelheim Investigational Site, Madrid, Spain

1160.48.03404 Boehringer Ingelheim Investigational Site, Madrid, Spain

1160.48.03406 Boehringer Ingelheim Investigational Site, Madrid, Spain

1160.48.03408 Boehringer Ingelheim Investigational Site, Móstoles (Madrid), Spain

1160.48.03410 Boehringer Ingelheim Investigational Site, Valencia, Spain

1160.48.04602 Boehringer Ingelheim Investigational Site, Falköping, Sweden

1160.48.04601 Boehringer Ingelheim Investigational Site, Göteborg, Sweden

1160.48.04607 Boehringer Ingelheim Investigational Site, Halmstad, Sweden

1160.48.04606 Boehringer Ingelheim Investigational Site, Kalmar, Sweden

1160.48.04603 Boehringer Ingelheim Investigational Site, Kungälv, Sweden

1160.48.04608 Boehringer Ingelheim Investigational Site, Lidköping, Sweden

1160.48.04605 Boehringer Ingelheim Investigational Site, Linköping, Sweden

1160.48.04604 Boehringer Ingelheim Investigational Site, Mölndal, Sweden

1160.48.04610 Boehringer Ingelheim Investigational Site, Stockholm, Sweden

1160.48.04609 Boehringer Ingelheim Investigational Site, Varberg, Sweden

1160.48.06108 Canberra Hospital, Garren, Australian Capital Territory, Australia

1160.48.06106 St George Public Hospital, Kogarah, New South Wales, Australia

1160.48.06110 Suite 13 level 4, Lismore, New South Wales, Australia

1160.48.06105 Flinders Medical Centre, Bedford Park, South Australia, Australia

1160.48.06104 Ecru, Box Hill, Victoria, Australia

1160.48.06102 Monash Medical Centre, Clayton, Victoria, Australia

1160.48.06101 Emeritus Research, Malvern, Victoria, Australia

1160.48.06103 Maroondah Hospital, Ringwood East, Victoria, Australia

1160.48.06113, Windsor, Victoria, Australia

1160.48.06111 Haemophillia & Thrombosis Service, Perth, Western Australia, Australia

Additional Information

Starting date: November 2004
Last updated: May 8, 2014

Page last updated: August 23, 2015

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