Venous ThromboembolismPhase 3NCT00657150

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

A Phase 3 study testing Enoxaparin and Dabigatran etexilate in people with Venous Thromboembolism, run by Boehringer Ingelheim at 108 sites in 19 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Venous Thromboembolism
What is being tested?: Enoxaparin and Dabigatran etexilate
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2,055 participants
Where: 108 sitesin 19 countries
Study dates: Mar 2008to Sep 2009
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Show all 28Show fewer

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.

Trial locations and contacts

108 sites in 19 countries.

Country

City, postcode or hospital

108 sites in 19 countries

India13 sites

1160.64.9105 Boehringer Ingelheim Investigational Site
Ahmedabad
1160.64.9112 Boehringer Ingelheim Investigational Site
Andhra Pradesh
1160.64.9109 Boehringer Ingelheim Investigational Site
Andhra Predesh
1160.64.9103 Boehringer Ingelheim Investigational Site
Bangalore
1160.64.9108 Boehringer Ingelheim Investigational Site
Bangalore
1160.64.9107 Boehringer Ingelheim Investigational Site
Baroda
1160.64.9110 Boehringer Ingelheim Investigational Site
Mangalore
1160.64.9104 Boehringer Ingelheim Investigational Site
Mohali
1160.64.9111 Boehringer Ingelheim Investigational Site
New Delhi
1160.64.9106 Boehringer Ingelheim Investigational Site
Pune
1160.64.9101 Boehringer Ingelheim Investigational Site
Ramdaspeth Nagpur
1160.64.9102 Boehringer Ingelheim Investigational Site
Secunderabad
1160.64.9113 Boehringer Ingelheim Investigational Site
Vadodara

Other trials in India

United States10 sites

1160.64.01010 Boehringer Ingelheim Investigational Site
Aurora, Colorado
1160.64.01007 Boehringer Ingelheim Investigational Site
Charleston, South Carolina
1160.64.01012 Boehringer Ingelheim Investigational Site
Clearwater, Florida
1160.64.01013 Boehringer Ingelheim Investigational Site
Conway, South Carolina
1160.64.01009 Boehringer Ingelheim Investigational Site
Englewood, Colorado
1160.64.01002 Boehringer Ingelheim Investigational Site
Houston, Texas
1160.64.01005 Boehringer Ingelheim Investigational Site
La Jolla, California
1160.64.01006 Boehringer Ingelheim Investigational Site
Lexington, Kentucky
1160.64.01003 Boehringer Ingelheim Investigational Site
Missoula, Montana
1160.64.01011 Boehringer Ingelheim Investigational Site
Spokane, Washington

Other trials in United States

Canada10 sites

1160.64.6012 Boehringer Ingelheim Investigational Site
Ajax, Ontario
1160.64.6003 Boehringer Ingelheim Investigational Site
Belleville, Ontario
1160.64.6004 Boehringer Ingelheim Investigational Site
Cambridge, Ontario
1160.64.6009 Boehringer Ingelheim Investigational Site
Edmonton, Alberta
1160.64.6008 Boehringer Ingelheim Investigational Site
Kitchener, Ontario
1160.64.6011 Boehringer Ingelheim Investigational Site
Oshawa, Ontario
1160.64.6002 Boehringer Ingelheim Investigational Site
Red Deer, Alberta
1160.64.6005 Boehringer Ingelheim Investigational Site
Sarnia, Ontario
1160.64.6007 Boehringer Ingelheim Investigational Site
Stratford, Ontario
1160.64.6013 Boehringer Ingelheim Investigational Site
Windsor, Ontario

Other trials in Canada

Sweden10 sites

1160.64.2101 Boehringer Ingelheim Investigational Site
Gothenburg
1160.64.2112 Boehringer Ingelheim Investigational Site
Halmstad
1160.64.2105 Boehringer Ingelheim Investigational Site
Hässleholm
1160.64.2109 Boehringer Ingelheim Investigational Site
Kalmar
1160.64.2103 Boehringer Ingelheim Investigational Site
Kungälv
1160.64.2106 Boehringer Ingelheim Investigational Site
Lidköping
1160.64.2102 Boehringer Ingelheim Investigational Site
Motala
1160.64.2108 Boehringer Ingelheim Investigational Site
Stockholm
1160.64.2111 Boehringer Ingelheim Investigational Site
Uppsala
1160.64.2107 Boehringer Ingelheim Investigational Site
Varberg

Other trials in Sweden

Netherlands7 sites

1160.64.1503 Boehringer Ingelheim Investigational Site
Amsterdam
1160.64.1507 Boehringer Ingelheim Investigational Site
Amsterdam
1160.64.1501 Boehringer Ingelheim Investigational Site
Hilversum
1160.64.1506 Boehringer Ingelheim Investigational Site
Hoofddorp
1160.64.1510 Boehringer Ingelheim Investigational Site
Leiden
1160.64.1505 Boehringer Ingelheim Investigational Site
Sittard
1160.64.1508 Boehringer Ingelheim Investigational Site
Zwolle

Other trials in Netherlands

Italy6 sites

1160.64.1401 Boehringer Ingelheim Investigational Site
Bologna
1160.64.1405 Boehringer Ingelheim Investigational Site
Parma
1160.64.1402 Boehringer Ingelheim Investigational Site
Pavia
1160.64.1407 Boehringer Ingelheim Investigational Site
Reggio Emilia
1160.64.1403 Boehringer Ingelheim Investigational Site
Roma
1160.64.1404 Boehringer Ingelheim Investigational Site
Torino

Other trials in Italy

Spain6 sites

1160.64.1904 Boehringer Ingelheim Investigational Site
Alcorcón (Madrid)
1160.64.1906 Boehringer Ingelheim Investigational Site
Barcelona
1160.64.1908 Boehringer Ingelheim Investigational Site
Fuenlabrada
1160.64.1901 Boehringer Ingelheim Investigational Site
Madrid
1160.64.1907 Boehringer Ingelheim Investigational Site
Madrid
1160.64.1905 Boehringer Ingelheim Investigational Site
Valencia

Other trials in Spain

Czechia5 sites

1160.64.7004 Boehringer Ingelheim Investigational Site
Chomutov
1160.64.7005 Boehringer Ingelheim Investigational Site
Jihlava
1160.64.7003 Boehringer Ingelheim Investigational Site
Kolín
1160.64.7001 Boehringer Ingelheim Investigational Site
Pilsen
1160.64.7002 Boehringer Ingelheim Investigational Site
Prague

Other trials in Czechia

Norway5 sites

1160.64.1603 Boehringer Ingelheim Investigational Site
Ålesund
1160.64.1601 Boehringer Ingelheim Investigational Site
Bodø
1160.64.1606 Boehringer Ingelheim Investigational Site
Elverum
1160.64.1604 Boehringer Ingelheim Investigational Site
Lillehammer
1160.64.1605 Boehringer Ingelheim Investigational Site
Tynset

Other trials in Norway

Poland5 sites

1160.64.1702 Boehringer Ingelheim Investigational Site
Krakow
1160.64.1704 Boehringer Ingelheim Investigational Site
Krakow
1160.64.1705 Boehringer Ingelheim Investigational Site
Lodz
1160.64.1703 Boehringer Ingelheim Investigational Site
Piekary Śląskie
1160.64.1701 Boehringer Ingelheim Investigational Site
Warsaw

Other trials in Poland

Australia4 sites

1160.64.2002 Boehringer Ingelheim Investigational Site
Box Hill, Victoria
1160.64.2003 Boehringer Ingelheim Investigational Site
Daws Park, South Australia
1160.64.2004 Boehringer Ingelheim Investigational Site
Nedlands, Western Australia
1160.64.2001 Boehringer Ingelheim Investigational Site
Windsor, Victoria

Other trials in Australia

Austria4 sites

1160.64.4004 Boehringer Ingelheim Investigational Site
Graz
1160.64.4002 Boehringer Ingelheim Investigational Site
Linz
1160.64.4001 Boehringer Ingelheim Investigational Site
Vienna
1160.64.4003 Boehringer Ingelheim Investigational Site
Wels

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Belgium4 sites

1160.64.5004 Boehringer Ingelheim Investigational Site
Brussels
1160.64.5002 Boehringer Ingelheim Investigational Site
Deurne
1160.64.5005 Boehringer Ingelheim Investigational Site
Lanaken
1160.64.5001 Boehringer Ingelheim Investigational Site
Leuven

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Denmark4 sites

1160.64.8004 Boehringer Ingelheim Investigational Site
Frederiksberg
1160.64.8003 Boehringer Ingelheim Investigational Site
Herlev
1160.64.8001 Boehringer Ingelheim Investigational Site
Hørsholm
1160.64.8002 Boehringer Ingelheim Investigational Site
Silkeborg

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Germany4 sites

1160.64.1104 Boehringer Ingelheim Investigational Site
Garmisch-Partenkirchen
1160.64.1101 Boehringer Ingelheim Investigational Site
Mainz
1160.64.1103 Boehringer Ingelheim Investigational Site
Markgröningen
1160.64.1102 Boehringer Ingelheim Investigational Site
Rheinfelden

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Hungary4 sites

1160.64.1201 Boehringer Ingelheim Investigational Site
Gyula
1160.64.1203 Boehringer Ingelheim Investigational Site
Kecskemét
1160.64.1202 Boehringer Ingelheim Investigational Site
Szeged
1160.64.1204 Boehringer Ingelheim Investigational Site
Székesfehérvár

Other trials in Hungary

Finland3 sites

1160.64.9002 Boehringer Ingelheim Investigational Site
Jyväskylä
1160.64.9001 Boehringer Ingelheim Investigational Site
Oulu
1160.64.9003 Boehringer Ingelheim Investigational Site
Tampere

Other trials in Finland

South Africa3 sites

1160.64.1801 Boehringer Ingelheim Investigational Site
Bryanston
1160.64.1804 Boehringer Ingelheim Investigational Site
Cape Western Province
1160.64.1802 Boehringer Ingelheim Investigational Site
Plumstead

Other trials in South Africa

New Zealand1 site

1160.64.3001 Boehringer Ingelheim Investigational Site
Takapuna Auckland

Other trials in New Zealand

About this study

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)

Conditions: Venous Thromboembolism
Being tested: Enoxaparin, Dabigatran etexilate
Medical subject headings: Venous Thromboembolism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

EnoxaparinDrug
40 mg once daily
Dabigatran etexilateDrug
220 mg once daily

Study groups in NCT00657150
Study group	Role	What they receive
Dabigatran etexilate	Experimental	220 mg once daily Receives: Drug: Dabigatran etexilate
Enoxaparin	Active comparator	40 mg once daily Receives: Drug: Enoxaparin

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 28-35 days

Secondary outcomes (11)

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
Measured: 28-35 days
Number of Participants With Proximal Deep Vein Thrombosis During Treatment Period
Proximal Deep Vein Thrombosis as adjudicated by the VTE events committee
Measured: 28-35 days
Number of Participants With Total Deep Vein Thrombosis During Treatment Period
Total Deep Vein Thrombosis as adjudicated by the VTE events committee
Measured: 28-35 days
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
Measured: 28-35 days
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
Measured: 28-35 days
Number of Participants Who Died During Treatment Period
All cause death, as adjudicated by the VTE events committee
Measured: 28-35 days
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).
Measured: 3 months
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.
Measured: 28-35 days
Blood Transfusion
Number of treated and operated patients with required blood transfusion on day of surgery.
Measured: Day 1
Volume of Blood Loss
Volume of blood loss for treated and operated patients during surgery.
Measured: Day 1
Laboratory Analyses
Frequency of patients with possible clinically significant abnormalities.
Measured: First administration to end of study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2008Sep 2009

First posted14 Apr 2008 (estimated)
Study startMar 2008
Primary completionSep 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Enrolment: 2,055 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00657150
Sponsor's protocol ID: 1160.64
Other IDs: 2007-002630-11
Status last verified: Dec 2013
First submitted: 27 Mar 2008
Last updated: 2 Jul 2014
Results posted: Yes, on ClinicalTrials.gov

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.
PubMed 26578849
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.
PubMed 21225098

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults
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Treatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants With Solid and Hematologic Cancers
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RecruitingPhase 3
REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants
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Recruiting
DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis
Venous Thromboembolism, Deep Venous Thrombosis

All Venous Thromboembolism trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT00657150
Acronym / sponsor ID: 1160.64
Conditions: Venous Thromboembolism
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 2,055 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Mar 2008
Primary completion: Sep 2009 (actual)
First posted: 14 Apr 2008 (estimated)
Results: Posted 17 Dec 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Number of arms: 2

Arm	Type	Receives
Dabigatran etexilate	Experimental	Drug: Dabigatran etexilate220 mg once daily
Enoxaparin	Active comparator	Drug: Enoxaparin40 mg once daily

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (28 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Enoxaparin40 mg once daily	Drug	Enoxaparin
Dabigatran etexilate220 mg once daily	Drug	Dabigatran etexilate

Primary outcome

Number of Participants With Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period
Time frame: 28-35 days
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.

11 secondary outcomes

Number of Participants With Major Venous Thromboembolic Event and Venous Thromboembolic Event-related Mortality During Treatment Period
Time frame: 28-35 days
Number of Participants With Proximal Deep Vein Thrombosis During Treatment Period
Time frame: 28-35 days
Number of Participants With Total Deep Vein Thrombosis During Treatment Period
Time frame: 28-35 days
Number of Participants With Symptomatic Deep Vein Thrombosis During Treatment Period
Time frame: 28-35 days
Number of Participants With Pulmonary Embolism During Treatment Period
Time frame: 28-35 days
Number of Participants Who Died During Treatment Period
Time frame: 28-35 days
Number of Participants With Total Venous Thromboembolic Event (VTE) and All-cause Mortality During the Follow-up Period
Time frame: 3 months
Number of Participants With Bleeding Events (Defined According to Modified McMaster Criteria) During Treatment Period
Time frame: 28-35 days
Blood Transfusion
Time frame: Day 1
Volume of Blood Loss
Time frame: Day 1
Laboratory Analyses
Time frame: First administration to end of study

Results and safety

Results posted to the registry on 17 Dec 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Dabigatran 220mg	1,010	895
Enoxaparin	1,003	910

Primary outcome: Number of Participants With Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period

Time frame: 28-35 days. Number. Unit: Participants

Measure	Dabigatran 220mg n = 792	Enoxaparin n = 786
Value	61	69

Dabigatran 220mg vs Enoxaparin: Risk Difference (Percentage): -1.08 (95% CI -3.79 to 1.64), p < 0.0001, Normal approximation

Population analysed: Full Analysis Set (randomised, had taken at least 1 dose of oral or subcutaneous trial medication, had undergone surgery, had evaluable negative venogram for both distal and proximal DVT in both legs or positive venography in any 1 segment of 1 or both legs, or confirmed symptomatic DVT, PE or death during the treatment period.)

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: 31 - 38 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dabigatran 220mg	57 of 1,010 (5.6%)	389 of 1,010 (38.5%)	Not reported
Enoxaparin	59 of 1,003 (5.9%)	389 of 1,003 (38.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 26578849Eriksson 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.
Derived from this study: PubMed 21225098Eriksson 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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Treatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants With Solid and Hematologic Cancers
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Symptomatic Venous Thromboembolism (VTE)
Recruiting
DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis
Venous Thromboembolism, Deep Venous Thrombosis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boehringer Ingelheim study chair

Boehringer Ingelheim

108 sites in 19 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Enoxaparin and Dabigatran etexilate in people with Venous Thromboembolism, run by Boehringer Ingelheim at 108 sites in 19 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 108 sites in India, United States, Canada, Sweden, Netherlands and 14 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Dec 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period (time frame: 28-35 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00657150, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2014.