Venous ThromboembolismPhase 3NCT00329628
Rivaroxaban (10mg) Given Once Daily in Patients Undergoing Total Hip Replacement Compared to Enoxaparin
A Phase 3 study testing Rivaroxaban (BAY59-7939) and Enoxaparin in people with Venous Thromboembolism, run by Bayer at 215 sites in 28 countries.
Trial summary
The purpose of this study is to assess if 10 mg BAY 59-7939, taken once daily as a tablet, is safe and prevent blood clot which may form after total hip replacement operation. 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?
- Rivaroxaban (BAY59-7939) and Enoxaparin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,541 participants
- Where
- 215 sitesin 28 countries
- Study dates
- Feb 2006to Mar 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Male and female patients aged 18 years or above
- Patients scheduled for elective total hip replacement
Who cannot join
- Planned, staged total bilateral hip replacement
- Active bleeding or high risk of bleeding contraindicating treatment with low molecular weight heparin
- Contraindication listed in the labeling or conditions precluding patient treatment with enoxaparin
- Conditions prohibiting bilateral venography (e.g. amputation of one leg, allergy to contrast media)
Trial locations and contacts
215 sites in 28 countries.
215 sites in 28 countries
Italy20 sites
Study site
Alghero, Sassari, 07041
Study site
Ancona, 60126
Study site
Bergamo, 24128
Study site
Bologna, 40136
Study site
Busto Arsizio, Varese, 21052
Study site
Ferrara, 44100
Study site
Florence, 50139
Study site
Genova, 16132
Study site
Gubbio, Perugia, 06024
Study site
Milan, 20132
Study site
Milan, 20162
Study site
Monza, Milano, 20052
Study site
Palermo, 90129
Study site
Reggio Emilia, 42100
Study site
Roma, 00168
Study site
Rozzano, Milano, 20089
Study site
San Donato Milanese, Milano, 20097
Study site
Sassari, 07100
Study site
Torino, 10126
Study site
Varese, 21100
Poland19 sites
Study site
Bialystok, 15-276
Study site
Bydgoszcz, 85-094
Study site
Bydgoszcz, 85-681
Study site
Gdansk, 80-803
Study site
Katowice, 40-635
Study site
Krakow, 30-901
Study site
Krakow, 31-826
Study site
Krakow, 31-913
Study site
Lodz, 91-002
Study site
Lublin, 20-090
Study site
Lublin, 20-718
Study site
Opole, 45-060
Study site
Poznan, 60-703
Study site
Sosnowiec, 41-200
Study site
Szczecin, 71-252
Study site
Warsaw, 00-909
Study site
Warsaw, 02-005
Study site
Warsaw, 03-242
Study site
Wroclaw, 51-128
Germany18 sites
Study site
Bad Mergentheim, Baden-Wurttemberg, 97980
Study site
Birkenwerder, Brandenburg, 16547
Study site
Bremen, Free Hanseatic City of Bremen, 28205
Study site
Dresden, Saxony, 01307
Study site
Düsseldorf, North Rhine-Westphalia, 40225
Study site
Frankfurt am Main, Hesse, 60528
Study site
Frankfurt am Main, Hesse, 65929
Study site
Fürth, Bavaria, 90766
Study site
Garmisch-Partenkirchen, Bavaria, 82467
Study site
Heidelberg, Baden-Wurttemberg, 69112
Study site
Marburg, Hesse, 35043
Study site
Rheinfelden, Baden-Wurttemberg, 79618
Study site
Rostock, Mecklenburg-Vorpommern, 18057
Study site
Sommerfeld, Brandenburg, 16766
Study site
Stuttgart, Baden-Wurttemberg, 70176
Study site
Wiesbaden, Hesse, 65191
Study site
Witten, North Rhine-Westphalia, 58448
Study site
Würzburg, Bavaria, 97080
Spain16 sites
Study site
Alcorcón, Madrid, 28922
Study site
Badalona, Barcelona, 08916
Study site
Barcelona, Barcelona, 08003
Study site
Barcelona, Barcelona, 08006
Study site
Barcelona, Barcelona, 08025
Study site
Barcelona, Barcelona, 08035
Study site
Barcelona, Barcelona, 08036
Study site
Castellon, Castellón de La Plana, 12004
Study site
Jaén, Jaén, 23007
Study site
L'Hospitalet de Llobregat, Barcelona, 08906
Study site
Madrid, Madrid, 28040
Study site
Oviedo, Principality of Asturias, 33006
Study site
Pamplona, Pamplona, 31008
Study site
Santiago de Compostela, A Coruña, 15706
Study site
Valencia, Valencia, 46010
Study site
Vitoria-Gasteiz, Vitoria, 01009
United States13 sites
Study site
Aurora, Colorado, 80012
Study site
Benton, Arkansas, 72015
Study site
Birmingham, Alabama, 35205
Study site
Charleston, South Carolina, 29414
Study site
Dallas, Texas, 75231
Study site
Decatur, Georgia, 30033
Study site
Grapevine, Texas, 76051
Study site
La Jolla, California, 92037
Study site
Lubbock, Texas, 79410
Study site
Missoula, Montana, 59802
Study site
Northport, Alabama, 35476
Study site
Phoenix, Arizona, 85023
Study site
San Antonio, Texas, 78233
France13 sites
Study site
Bois-Guillaume, 76230
Study site
Le Chesnay, 78150
Study site
Liévin, 62806
Study site
Monaco, 98000
Study site
Nantes, 44277
Study site
Paris, 75019
Study site
Paris, 75674
Study site
Paris, 75877
Study site
Paris, 75960
Study site
Saint-Herblain, 44819
Study site
Soyaux, 16800
Study site
Vandœuvre-lès-Nancy, 54511
Study site
Vannes, 56000
Belgium10 sites
Study site
Antwerp, 2020
Study site
Brasschaat, 2930
Study site
Bruges, 8000
Study site
Genk, 3600
Study site
Hasselt, 3500
Study site
Huy, 4500
Study site
Merksem, 2170
Study site
Pellenberg, 3212
Study site
Reet, 2840
Study site
Roeselare, 8800
Czechia10 sites
Study site
České Budějovice, 370 87
Study site
Hradec Králové, 500 05
Study site
Jindřichův Hradec, 377 38
Study site
Karlovy Vary, 360 66
Study site
Mladá Boleslav, 293 50
Study site
Olomouc, 775 20
Study site
Pilsen, 304 60
Study site
Prague, 169 02
Study site
Pribram I, 261 26
Study site
Prostějov, 796 04
Canada9 sites
Study site
Edmonton, Alberta, T6G 2B7
Study site
Kitchener, Ontario, N2G 1G3
Study site
Montreal, Quebec, H3G 1A4
Study site
Montreal, Quebec, H3T 1M5
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Oakville, Ontario, L6J 3L7
Study site
Oshawa, Ontario, L1J 2J2
Study site
Peterborough, Ontario, K9J 7C6
Study site
Québec, Quebec, G1L 3L5
Study site
Stratford, Ontario, N5A 2Y6
Hungary9 sites
Study site
Békéscsaba, 5600
Study site
Budapest, 1076
Study site
Budapest, 1089
Study site
Győr, 9024
Study site
Kaposvár, Hungary, 7400
Study site
Kecskemét, 6000
Study site
Szeged, 6725
Study site
Székesfehérvár, 8000
Study site
Szekszárd, 7100
Austria8 sites
Study site
Graz, Styria, 8036
Study site
Innsbruck, Tyrol, 6020
Study site
Linz, Upper Austria, 4010
Study site
Linz, Upper Austria, 4020
Study site
Ried, Upper Austria, 4910
Study site
Vienna, State of Vienna, 1140
Study site
Wels, Upper Austria, 4600
Study site
Wiener Neustadt, Lower Austria, 2700
Israel8 sites
Study site
Beersheba, Israel, 84101
Study site
Haifa, Israel, 31096
Study site
Holon, Israel, 58100
Study site
Kfar Saba, Israel, 44281
Study site
Petah Tikva, Israel, 49100
Study site
Tel Aviv, Israel, 64239
Study site
Tel HaShomer, 52621
Study site
Tsrifin, Israel, 70300
Argentina7 sites
Study site
Avellaneda, Buenos Aires, 1870
Study site
Berazategui, Buenos Aires, 1884
Study site
Buenos Aires, Buenos Aires F.D., 1426
Study site
Buenos Aires, Buenos Aires F.D., C1039AAO
Study site
Buenos Aires, Buenos Aires F.D., C1280AEB
Study site
Buenos Aires, Buenos Aires F.D., C1406FWY
Study site
Buenos Aires, Buenos Aires F.D., C1425AGP
Netherlands7 sites
Study site
Amsterdam, 1105 AZ
Study site
Hilversum, 1213 XZ
Study site
Hoofddorp, 2134 TM
Study site
Leiden, 2334 CK
Study site
Nijmegen, 6522 JV
Study site
Oss, 5342 BT
Study site
Zwolle, 8011 JW
Sweden6 sites
Study site
Gothenburg, 416 85
Study site
Halmstad, 301 85
Study site
Jönköping, 551 85
Study site
Lidköping, 531 85
Study site
Varberg, 432 81
Study site
Västervik, 593 81
Australia5 sites
Study site
Adelaide, South Australia, 5042
Study site
Fremantle, Western Australia, 6160
Study site
Melbourne, Victoria, 3128
Study site
Melbourne, Victoria, 3181
Study site
Sydney, New South Wales, 2217
Denmark5 sites
Study site
Frederiksberg, 2000
Study site
Hellerup, 2900
Study site
Herlev, 2730
Study site
Hørsholm, DK-2970
Study site
Silkeborg, 8600
Norway5 sites
Study site
Baerum Postterminal, 1306
Study site
Elverum, 2409
Study site
Gjøvik, 2819
Study site
Lillehammer, 2609
Study site
Notodden, NO-3675
Turkey (Türkiye)5 sites
Study site
Adana, 01330
Study site
Istanbul, 34093
Study site
Istanbul, 34662
Study site
Istanbul, 34722
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Izmir, 35340
Brazil4 sites
Study site
Porto Alegre, Rio Grande do Sul, 90470 340
Study site
Porto Alegre, Rio Grande do Sul, 90610-000
Study site
Rio de Janeiro, Rio de Janeiro, 20 232 092
Study site
São Paulo, São Paulo, 04039-004
Finland3 sites
Study site
Jyväskylä, 40620
Study site
Mikkeli, FIN-50100
Study site
Seinäjoki, FIN 60220
Mexico3 sites
Study site
Edo. de Mexico, 53120
Study site
Monterrey, Nuevo León, 64380
Study site
Monterrey, Nuevo León, 64460
Slovakia3 sites
Study site
Bratislava, 826 06
Study site
Kosice - Saca, Slovakia, 040 15
Study site
Žilina, 012 07
South Africa3 sites
Study site
Pretoria, Gauteng, 0084
Study site
Somerset West, Western Cape, 7130
Study site
Worcester, Western Cape, 6850
Greece2 sites
Study site
Haidari, Attica, 12462
Study site
Kifissia, Attica, 14561
About this study
Official title: RECORD 1 Study: REgulation of Coagulation in ORthopedic Surgery to Prevent DVT and PE, Controlled, Double-blind, Randomized Study of BAY 59-7939 in the Extended Prevention of VTE in Patients Undergoing Elective Total Hip Replacement
The purpose of this study is to assess if 10 mg BAY 59-7939, taken once daily as a tablet, is safe and prevent blood clot which may form after total hip replacement operation.
- Conditions
- Venous Thromboembolism
- Being tested
- Rivaroxaban (BAY59-7939), Enoxaparin
- Keywords
- Prevention, Thromboembolism
- Medical subject headings
- Venous Thromboembolism, Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rivaroxaban (BAY59-7939)Drug
10 mg OD tablet of rivaroxaban administered for 36 +/- 4 days
EnoxaparinDrug
Syringe of Enoxaparin active substance at a dose of 40 mg administered for 13 +/- 2 days
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Rivaroxaban (BAY59-7939) |
| Arm 2 | Active comparator | Not described Receives: Drug: Enoxaparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite endpoint of total VTE i.e.: Any DVT (proximal and/or distal), Non fatal PE, Death of all causes
Measured: Treatment period : up to day 36+/-6
Secondary outcomes (8)
Incidence of the composite endpoint comprising proximal DVT, non-fatal PE and VTE- related death (major VTE)
Measured: Treatment period : up to day 36+/-6
Incidence of symptomatic VTE (DVT, PE)
Measured: Treatment period : up to day 36+/-6
Incidence of DVT (total, proximal, distal)
Measured: Treatment period : up to day 36+/-6
Incidence of symptomatic VTE during follow-up
Measured: Follow-up period: following 36+/-6 days
The composite endpoint comprising major VTE and treatment-emergent major bleeding
Measured: For major VTE, treatment period: up to Day 36+/-6 ; for major bleeding, from first dose of double-blind study medication to up to two days after last dose of double-blind study medication
Incidence of the composite endpoint that results from the primary endpoint by substituting VTE related death for all death
Measured: Treatment period : up to day 36+/-6
Incidence of the composite endpoint that results from major VTE by substituting all cause mortality for VTE-related death
Measured: Treatment period : up to day 36+/-6
Treatment-emergent major bleedings
Measured: From first dose of double-blind study medication to up to two days after last dose of double-blind study medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2006 (estimated)
- Study startFeb 2006
- Primary completionMar 2007
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 BayerThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 4,541 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00329628
- Sponsor's protocol ID
- 11354
- Other IDs
- EudraCT: 2005-004351-35
- Status last verified
- Oct 2014
- First submitted
- 24 May 2006
- Last updated
- 28 Oct 2014
- Results posted
- No
Publications
Eriksson BI, Borris LC, Friedman RJ, Haas S, Huisman MV, Kakkar AK, Bandel TJ, Beckmann H, Muehlhofer E, Misselwitz F, Geerts W; RECORD1 Study Group. Rivaroxaban versus enoxaparin for thromboprophylaxis after hip arthroplasty. N Engl J Med. 2008 Jun 26;358(26):2765-75. doi: 10.1056/NEJMoa0800374.
PubMed 18579811
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RECORD 1 Study: REgulation of Coagulation in ORthopedic Surgery to Prevent DVT and PE, Controlled, Double-blind, Randomized Study of BAY 59-7939 in the Extended Prevention of VTE in Patients Undergoing Elective Total Hip Replacement
- ClinicalTrials.gov ID
- NCT00329628
- Acronym / sponsor ID
- 11354
- Conditions
- Venous Thromboembolism
- Keywords
- Prevention, Thromboembolism
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,541 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Feb 2006
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 25 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess if 10 mg BAY 59-7939, taken once daily as a tablet, is safe and prevent blood clot which may form after total hip replacement operation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Rivaroxaban (BAY59-7939) |
| Arm 2 | Active comparator | Drug: Enoxaparin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male and female patients aged 18 years or above
- Patients scheduled for elective total hip replacement
Key exclusion criteria (4 listed)
- Planned, staged total bilateral hip replacement
- Active bleeding or high risk of bleeding contraindicating treatment with low molecular weight heparin
- Contraindication listed in the labeling or conditions precluding patient treatment with enoxaparin
- Conditions prohibiting bilateral venography (e.g. amputation of one leg, allergy to contrast media)
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 |
|---|---|---|
| Rivaroxaban (BAY59-7939)10 mg OD tablet of rivaroxaban administered for 36 +/- 4 days | Drug | Arm 1 |
| EnoxaparinSyringe of Enoxaparin active substance at a dose of 40 mg administered for 13 +/- 2 days | Drug | Arm 2 |
Primary outcome
Composite endpoint of total VTE i.e.: Any DVT (proximal and/or distal), Non fatal PE, Death of all causes
Time frame: Treatment period : up to day 36+/-6
8 secondary outcomes
Incidence of the composite endpoint comprising proximal DVT, non-fatal PE and VTE- related death (major VTE)
Time frame: Treatment period : up to day 36+/-6
Incidence of symptomatic VTE (DVT, PE)
Time frame: Treatment period : up to day 36+/-6
Incidence of DVT (total, proximal, distal)
Time frame: Treatment period : up to day 36+/-6
Incidence of symptomatic VTE during follow-up
Time frame: Follow-up period: following 36+/-6 days
The composite endpoint comprising major VTE and treatment-emergent major bleeding
Time frame: For major VTE, treatment period: up to Day 36+/-6 ; for major bleeding, from first dose of double-blind study medication to up to two days after last dose of double-blind study medication
Incidence of the composite endpoint that results from the primary endpoint by substituting VTE related death for all death
Time frame: Treatment period : up to day 36+/-6
Incidence of the composite endpoint that results from major VTE by substituting all cause mortality for VTE-related death
Time frame: Treatment period : up to day 36+/-6
Treatment-emergent major bleedings
Time frame: From first dose of double-blind study medication to up to two days after last dose of double-blind study medication
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2014.
- Derived from this study: PubMed 18579811Eriksson BI, Borris LC, Friedman RJ, Haas S, Huisman MV, Kakkar AK, Bandel TJ, Beckmann H, Muehlhofer E, Misselwitz F, Geerts W; RECORD1 Study Group. Rivaroxaban versus enoxaparin for thromboprophylaxis after hip arthroplasty. N Engl J Med. 2008 Jun 26;358(26):2765-75. doi: 10.1056/NEJMoa0800374.
- Click here and search for information of Bayer products for EuropeLink provided by the sponsor.
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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.
Bayer Study Director study director
Bayer
215 sites in 28 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rivaroxaban (BAY59-7939) and Enoxaparin in people with Venous Thromboembolism, run by Bayer at 215 sites in 28 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 2 inclusion and 4 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 28 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 215 sites in Italy, Poland, Germany, Spain, United States and 23 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Composite endpoint of total VTE i.e.: Any DVT (proximal and/or distal), Non fatal PE, Death of all causes (time frame: Treatment period : up to day 36+/-6). 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 NCT00329628, which also lists 1 linked publication.
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 28 Oct 2014.