AzTrials
AzTrials

PreventionPhase 3RECORD 2NCT00332020

Regulation of Coagulation in Orthopedic Surgery to Prevent DVT and PE, a Controlled, Double-blind, Randomized Study of BAY 59-7939 in the Extended Prevention of VTE in Patients Undergoing Elective Total Hip Replacement

A Phase 3 study testing Rivaroxaban (BAY59-7939) and Enoxaparin in people with Prevention and Venous Thromboembolism, run by Bayer at 126 sites in 23 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 purpose of this study is to assess if 10 mg BAY 59-7939, taken once daily as a tablet, is safe and can help prevent blood clots forming after a hip 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
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,457 participants
Where
126 sitesin 23 countries
Study dates
Feb 2006to Jun 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

126 sites in 23 countries.

126 sites in 23 countries

Canada11 sites

  • Study site

    Oshawa, Ontario, L1G 2B9

  • Study site

    Ottawa, Ontario, K1H 8L6

  • Study site

    Ottawa, Ontario, K1Y 4E9

  • Study site

    Penticton, British Columbia, V2A 5C8

  • Study site

    Red Deer, Alberta, T4N 4E7

  • Study site

    Saint John, New Brunswick, E2L 4L2

  • Study site

    Scarborough Village, Ontario, M1M 3W3

  • Study site

    Scarborough Village, Ontario, M1P 2V5

  • Study site

    Thunder Bay, Ontario, P7B 6V4

  • Study site

    Windsor, Ontario, N9A 1E1

  • Study site

    Winnipeg, Manitoba, R3J 3M7

Other trials in Canada

China11 sites

  • Study site

    Beijing, 100035

  • Study site

    Beijing, 100044

  • Study site

    Beijing, 100853

  • Study site

    Guangzhou, Guangdong, 510405

  • Study site

    Jinan, Shandong, 250014

  • Study site

    Qingdao, Shandong, 266003

  • Study site

    Shanghai, 200025

  • Study site

    Shanghai, 200032

  • Study site

    Shanghai, 200233

  • Study site

    Shanghai, 200433

  • Study site

    Xi’an, Shanxi, 710004

Other trials in China

Brazil10 sites

  • Study site

    Batatais, São Paulo, 14300 000

  • Study site

    Belo Horizonte, Minas Gerais, 30170-132

  • Study site

    Belo Horizonte, Minas Gerais, 30380 090

  • Study site

    Curitiba, Paraná, 80050-350

  • Study site

    Marília, São Paulo, 17515-900

  • Study site

    Passo Fundo, Rio Grande do Sul, 99010-100

  • Study site

    Rio de Janeiro

  • Study site

    São Paulo, São Paulo, 0122-1020

  • Study site

    São Paulo, São Paulo, 04023-900

  • Study site

    São Paulo, São Paulo, 04262-000

Other trials in Brazil

Denmark9 sites

  • Study site

    Copenhagen, 2300

  • Study site

    Copenhagen, 2400

  • Study site

    Frederiksberg, 2000

  • Study site

    Glostrup Municipality, 2600

  • Study site

    Herlev, 2730

  • Study site

    Holbæk, 4300

  • Study site

    Hvidovre, 2650

  • Study site

    Silkeborg, 8600

  • Study site

    Viborg, 8800

Other trials in Denmark

Sweden9 sites

  • Study site

    Falköping, 521 85

  • Study site

    Hässleholm, 281 25

  • Study site

    Kungälv, 442 83

  • Study site

    Lidköping, 531 85

  • Study site

    Örebro, 701 85

  • Study site

    Stockholm, 112 81

  • Study site

    Sundsvall, 851 86

  • Study site

    Varberg, 432 81

  • Study site

    Vaxjo, 351 85

Other trials in Sweden

United Kingdom8 sites

  • Study site

    Chesterfield, Derbyshire, S44 5BL

  • Study site

    Dumfries, Dumfries and Galloway, DG1 4EP

  • Study site

    Epsom, Surrey, KT18 7EG

  • Study site

    Great Yarmouth, Norfolk, NR31 6LA

  • Study site

    Kirkcaldy, Fife, KY2 5AH

  • Study site

    Liverpool, Merseyside, L14 3LB

  • Study site

    London, Greater London, SE5 9RS

  • Study site

    Northampton, Northamptonshire, NN1 5BD

Other trials in United Kingdom

Italy7 sites

  • Study site

    Genova, 16132

  • Study site

    Lecco, 23900

  • Study site

    Modena, 41100

  • Study site

    Naples, 80131

  • Study site

    Parma, 43100

  • Study site

    Siena, 53100

  • Study site

    Udine, 33100

Other trials in Italy

Australia6 sites

  • Study site

    Canberra, Australian Capital Territory, 2605

  • Study site

    Geelong, Victoria, 3220

  • Study site

    Lismore, New South Wales, 2480

  • Study site

    Melbourne, Victoria, 3128

  • Study site

    Southport, Queensland, 4215

  • Study site

    Sydney, New South Wales, 2065

Other trials in Australia

India6 sites

  • Study site

    Bangalore, Bangalore, 560034

  • Study site

    Bangalore, 560001

  • Study site

    Hyderabad, Andhra Pradesh, 500034

  • Study site

    Ludhiana, Punjab, 141001

  • Study site

    Mumbai, 400012

  • Study site

    Secundrabad, Andhra Pradesh, 500003

Other trials in India

Peru6 sites

  • Study site

    Callao, CALLAO 2

  • Study site

    Lima, 01

  • Study site

    Lima, 31

  • Study site

    Lima, LIMA 11

  • Study site

    Lima, LIMA 1

  • Study site

    Lima Cercado, LIMA 1

Other trials in Peru

United States5 sites

  • Study site

    Bay Pines, Florida, 33744

  • Study site

    Birmingham, Alabama, 35205

  • Study site

    Denver, Colorado, 80222

  • Study site

    Miami, Florida, 33186

  • Study site

    Oklahoma City, Oklahoma, 73103

Other trials in United States

Norway5 sites

  • Study site

    Kongsvinger, 2212

  • Study site

    Namsos, 7800

  • Study site

    Oslo, 0264

  • Study site

    Oslo, 0440

  • Study site

    Tynset, 2501

Other trials in Norway

South Africa5 sites

  • Study site

    Bloemfontein, Freestate, 9300

  • Study site

    Cape Town, Western Cape, 7505

  • Study site

    Johannesburg, Gauteng, 2132

  • Study site

    Newcastle, KwaZulu-Natal, 2940

  • Study site

    Randburg, Gauteng, 2125

Other trials in South Africa

Colombia4 sites

  • Study site

    Barranquilla

  • Study site

    Bogotá

  • Study site

    Cali

  • Study site

    Medellín

Other trials in Colombia

Lithuania4 sites

  • Study site

    Kaunas, 44320

  • Study site

    Klaipėda, 92288

  • Study site

    Panevezys, 35144

  • Study site

    Šiauliai, 76231

Other trials in Lithuania

Portugal4 sites

  • Study site

    Lisbon, Lisbon District, 1069-166

  • Study site

    Porto, 4200-319

  • Study site

    Setúbal, Setúbal District, 299-182

  • Study site

    Torres Vedras, Torres Vedras, 2560-324

Other trials in Portugal

South Korea4 sites

  • Study site

    Daegu, 700721

  • Study site

    Kyunggido, Kyunggido, 471710

  • Study site

    Seoul, 135-710

  • Study site

    Seoul, 138-736

Other trials in South Korea

Estonia2 sites

  • Study site

    Tallinn, 10138

  • Study site

    Tartu, 51014

Other trials in Estonia

Indonesia2 sites

  • Study site

    Bandung, West Java, 40161

  • Study site

    Surabaya, Surabaya

Other trials in Indonesia

Latvia2 sites

  • Study site

    Liepāja, 3402

  • Study site

    Riga

Other trials in Latvia

Mexico2 sites

  • Study site

    Chihuahua, Chih., Chihuahua, 31000

  • Study site

    Guadalajara, Jalisco, 44280

Other trials in Mexico

New Zealand2 sites

  • Study site

    Auckland, 0622

  • Study site

    Auckland, 1023

Other trials in New Zealand

Taiwan2 sites

  • Study site

    Kaohsiung City, 833

  • Study site

    Taoyuan, 333

Other trials in Taiwan

About this study

Official title: RECORD 2 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 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 can help prevent blood clots forming after a hip replacement operation.

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 35 +/- 4 days

  • EnoxaparinDrug

    40 mg enoxaparin syringe administered for 12 +/- 2 days

Study groups in NCT00332020
Study groupRoleWhat they receive
Arm 1ExperimentalNot described
Receives: Drug: Rivaroxaban (BAY59-7939)
Arm 2Active comparatorNot described
Receives: Drug: Enoxaparin

What is being measured

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

  1. 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 35+/-6

Secondary outcomes (8)

  1. Incidence of the composite endpoint comprising proximal DVT, non-fatal PE and VTE- related death (major VTE)

    Measured: Treatment period: up to day 35+/-6

  2. Incidence of symptomatic VTE (DVT, PE)

    Measured: Treatment period: up to day 35+/-6

  3. Incidence of DVT (total, proximal, distal)

    Measured: Treatment period: up to day 35+/-6

  4. Incidence of symptomatic VTE during follow-up

    Measured: Follow-up period: following 35+/-6 days

  5. The composite endpoint comprising major VTE and treatment-emergent major bleeding

    Measured: For major VTE, treatment period: up to Day 35+/-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

  6. 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 35+/-6

  7. 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 35+/-6

  8. 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.

  1. First posted31 May 2006 (estimated)
  2. Study startFeb 2006
  3. Primary completionMay 2007
  4. Study completionJun 2007

Resources

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
2,457 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00332020
Sponsor's protocol ID
11357
Other IDs
2005-004691-20, 2005
Acronym
RECORD 2
Status last verified
Jan 2015
First submitted
30 May 2006
Last updated
27 Jan 2015
Results posted
No

Publications

  • Kakkar AK, Brenner B, Dahl OE, Eriksson BI, Mouret P, Muntz J, Soglian AG, Pap AF, Misselwitz F, Haas S; RECORD2 Investigators. Extended duration rivaroxaban versus short-term enoxaparin for the prevention of venous thromboembolism after total hip arthroplasty: a double-blind, randomised controlled trial. Lancet. 2008 Jul 5;372(9632):31-9. doi: 10.1016/S0140-6736(08)60880-6. Epub 2008 Jun 24.

    PubMed 18582928

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 126 sites in 23 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 27 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 126 sites in Canada, China, Brazil, Denmark, Sweden and 18 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 35+/-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 NCT00332020, 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 Jan 2015.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in