PreventionPhase 3RECORD 3NCT00361894
Regulation of Coagulation in Orthopedic Surgery to Prevent Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE). A Study of BAY 59-7939 in the Prevention of VTE in Subjects Undergoing Elective Total Knee Replacement.
A Phase 3 study testing Rivaroxaban (BAY59-7939) and Enoxaparin in people with Prevention and Venous Thromboembolism, run by Bayer at 143 sites in 19 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 prevents blood clot which may form after a knee replacement operation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prevention, 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
- 2,531 participants
- Where
- 143 sitesin 19 countries
- Study dates
- Feb 2006to Jan 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
Inclusion Criteria:- Male and female patients aged 18 years or above- Patients scheduled for elective total knee replacement Exclusion Criteria:- Active bleeding or high risk of bleeding contraindicating treatment with LMWH- Contraindication listed in the labeling or conditions precluding subject treatment with enoxaparin or requiring dose adjustment (e.g. severe renal impairment, please refer to the local label of enoxaparin in your country)- Conditions prohibiting bilateral venography (e.g. amputation of 1 leg, allergy to contrast media)
Trial locations and contacts
143 sites in 19 countries.
143 sites in 19 countries
France14 sites
Study site
Bois-Guillaume, 76230
Study site
Clermont-Ferrand, 63050
Study site
Liévin, 62806
Study site
Marseille, 13008
Study site
Monaco, 98000
Study site
Nantes, 44277
Study site
Nice, 06000
Study site
Nice, 06002
Study site
Paris, 75019
Study site
Paris, 75674
Study site
Paris, 75877
Study site
Paris, 75960
Study site
Soyaux, 16800
Study site
Vandœuvre-lès-Nancy, 54511
Italy12 sites
Study site
Abano Terme, Padova, 35031
Study site
Alghero, Sassari, 07041
Study site
Bologna, 40136
Study site
Florence, 50139
Study site
Gubbio, Perugia, 06024
Study site
Lecco, 23900
Study site
Padova, 35127
Study site
Parma, 43100
Study site
Roma, 00168
Study site
San Donato Milanese, Milano, 20097
Study site
Udine, 33100
Study site
Varese, 21100
Germany11 sites
Study site
Bad Mergentheim, Baden-Wurttemberg, 97980
Study site
Bremen, Free Hanseatic City of Bremen, 28205
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
Rheinfelden, Baden-Wurttemberg, 79618
Study site
Sommerfeld, Brandenburg, 16766
Study site
Witten, North Rhine-Westphalia, 58448
Study site
Würzburg, Bavaria, 97080
Canada10 sites
Study site
Burlington, Ontario, L7R 4C4
Study site
Kitchener, Ontario, N2G 1G3
Study site
Oakville, Ontario, L6J 3M5
Study site
Oshawa, Ontario, L1G 2B9
Study site
Ottawa, Ontario, K1Y 4E9
Study site
Penticton, British Columbia, V2A 5C8
Study site
Peterborough, Ontario, K9J 7C6
Study site
Saint John, New Brunswick, E2L 4L2
Study site
Scarborough Village, Ontario, M1E 4B9
Study site
Windsor, Ontario, N9A 1E1
Poland10 sites
Study site
Bialystok, 15-276
Study site
Bydgoszcz, 85-094
Study site
Gdansk, 80-803
Study site
Krakow, 31-826
Study site
Lodz, 91-002
Study site
Lublin, 20-090
Study site
Lublin, 20-718
Study site
Szczecin, 71-252
Study site
Warsaw, 00-909
Study site
Warsaw, 02-637
South Africa10 sites
Study site
Bloemfontein, Freestate, 9300
Study site
Durban, KwaZulu-Natal, 4030
Study site
Johannesburg, Gauteng, 2132
Study site
Newcastle, KwaZulu-Natal, 2940
Study site
Pretoria, Gauteng, 0084
Study site
Pretoria, Gauteng, PRETORIA
Study site
Pretoria, Gauteng
Study site
Randburg, Gauteng, 2125
Study site
Somerset West, Western Cape, 7130
Study site
Worcester, Western Cape, 6850
Spain10 sites
Study site
Alcorcón, Madrid, 28922
Study site
Badalona, Barcelona, 08916
Study site
Barcelona, Barcelona, 08006
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
Madrid, Madrid, 28040
Study site
Pamplona, Pamplona, 31008
Study site
Valencia, Valencia, 46010
Czechia8 sites
Study site
Brno, 62500
Study site
Chomutov, 430 01
Study site
Havlíčkův Brod, 580 01
Study site
Jihlava, 586 01
Study site
Kolín, 280 00
Study site
Pardubice, 530 03
Study site
Pilsen, 304 60
Study site
Prague, Tschechien, 180 81
Sweden8 sites
Study site
Falköping, 521 85
Study site
Gothenburg, 416 85
Study site
Halmstad, 301 85
Study site
Hässleholm, 281 25
Study site
Jönköping, 551 85
Study site
Kungälv, 442 83
Study site
Lidköping, 531 85
Study site
Varberg, 432 81
Belgium7 sites
Study site
Antwerp, 2020
Study site
Hasselt, 3500
Study site
Liège, 4000
Study site
Merksem, 2170
Study site
Pellenberg, 3212
Study site
Reet, 2840
Study site
Roeselare, 8800
Israel7 sites
Study site
Beersheba, Israel, 84101
Study site
Haifa, Israel, 31096
Study site
Holon, Israel, 58100
Study site
Kfar Saba, Israel, 44281
Study site
Tel Aviv, Israel, 64239
Study site
Tel HaShomer, 52621
Study site
Tsrifin, Israel, 70300
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
China6 sites
Study site
Beijing, 100035
Study site
Beijing, 100044
Study site
Beijing, 100853
Study site
Shanghai, 200025
Study site
Shanghai, 200032
Study site
Shanghai, 200233
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
Elverum, 2409
Study site
Gjøvik, 2819
Study site
Kongsvinger, 2212
Study site
Lillehammer, 2609
Study site
Namsos, 7800
Austria4 sites
Study site
Graz, Styria, 8036
Study site
Innsbruck, Tyrol, 6020
Study site
Linz, Upper Austria, 4010
Study site
Vienna, State of Vienna, 1140
Mexico3 sites
Study site
Chihuahua, Chih., Chihuahua, 31000
Study site
Guadalajara, Jalisco, 44280
Study site
Hermosillo, Sonora, 83000
Peru3 sites
Study site
Callao, CALLAO 2
Study site
Lima, LIMA 11
Study site
Lima, LIMA 1
About this study
Official title: RECORD 3 Study: REgulation of Coagulation in ORthopedic Surgery to Prevent DVT and PE; a Controlled., Double-blind, Randomized Study of BAY 59-7939 in the Prevention of VTE in Subjects Undergoing Elective Total Knee Replacement.
The purpose of this study is to assess if 10 mg Bay 59-7939, taken once daily as a tablet, is safe and prevents blood clot which may form after a knee replacement operation.
- Conditions
- Prevention, Venous Thromboembolism
- Being tested
- Rivaroxaban (BAY59-7939), Enoxaparin
- Medical subject headings
- Venous 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 rivaroxaban (tablet) once daily administered for 13 +/- 2 days
EnoxaparinDrug
Syringe of enoxaparin at a dose of 40 mg 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 13+/-4
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 13+/-4
Incidence of symptomatic VTE (DVT, PE)
Measured: Treatment period: up to Day 13+/-4
Incidence of DVT (total, proximal, distal)
Measured: Treatment period: up to Day 13+/-4
Incidence of symptomatic VTE during follow-up
Measured: Follow-up period: following 13+/-4 days
The composite endpoint comprising major VTE and treatment-emergent major bleeding
Measured: For major VTE, treatment period: up to Day 13+/-4 ; 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 13+/-4
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 13+/-4
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 posted9 Aug 2006 (estimated)
- Study startFeb 2006
- Primary completionJan 2007
- Study completionJan 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 PreventionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2,531 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
- NCT00361894
- Sponsor's protocol ID
- 11356
- Other IDs
- EudraCT: 2005-004620-40
- Acronym
- RECORD 3
- Status last verified
- Oct 2014
- First submitted
- 8 Aug 2006
- Last updated
- 27 Oct 2014
- Results posted
- No
Publications
Lassen MR, Ageno W, Borris LC, Lieberman JR, Rosencher N, Bandel TJ, Misselwitz F, Turpie AG; RECORD3 Investigators. Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty. N Engl J Med. 2008 Jun 26;358(26):2776-86. doi: 10.1056/NEJMoa076016.
PubMed 18579812
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RECORD 3 Study: REgulation of Coagulation in ORthopedic Surgery to Prevent DVT and PE; a Controlled., Double-blind, Randomized Study of BAY 59-7939 in the Prevention of VTE in Subjects Undergoing Elective Total Knee Replacement.
- ClinicalTrials.gov ID
- NCT00361894
- Acronym / sponsor ID
- RECORD 3 / 11356
- Conditions
- Prevention, Venous Thromboembolism
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,531 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Feb 2006
- Primary completion
- Jan 2007 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 9 Aug 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 prevents blood clot which may form after a knee replacement operation.
Study design
- Primary purpose
- Prevention
- 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
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 rivaroxaban (tablet) once daily administered for 13 +/- 2 days | Drug | Arm 1 |
| EnoxaparinSyringe of enoxaparin at a dose of 40 mg 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 13+/-4
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 13+/-4
Incidence of symptomatic VTE (DVT, PE)
Time frame: Treatment period: up to Day 13+/-4
Incidence of DVT (total, proximal, distal)
Time frame: Treatment period: up to Day 13+/-4
Incidence of symptomatic VTE during follow-up
Time frame: Follow-up period: following 13+/-4 days
The composite endpoint comprising major VTE and treatment-emergent major bleeding
Time frame: For major VTE, treatment period: up to Day 13+/-4 ; 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 13+/-4
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 13+/-4
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 27 Oct 2014.
- Derived from this study: PubMed 18579812Lassen MR, Ageno W, Borris LC, Lieberman JR, Rosencher N, Bandel TJ, Misselwitz F, Turpie AG; RECORD3 Investigators. Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty. N Engl J Med. 2008 Jun 26;358(26):2776-86. doi: 10.1056/NEJMoa076016.
- Click here to find information about studies related to Bayer Healthcare products conducted in 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
143 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 Rivaroxaban (BAY59-7939) and Enoxaparin in people with Prevention and Venous Thromboembolism, run by Bayer at 143 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?
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 27 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 143 sites in France, Italy, Germany, Canada, Poland 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?
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 13+/-4). 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 NCT00361894, 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 27 Oct 2014.