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AzTrials

Venous ThromboembolismPhase 3RECORD 4NCT00362232

Regulation of Coagulation in Orthopedic Surgery to Prevent Deep Vein Thromboembolism (DVT) and Pulmonary Embolism (PE). A Study of BAY59-7939 in the Prevention of Venous Thrombo Embolism (VTE) in Subjects Undergoing Elective Total Knee Replacement.

A Phase 3 study testing Rivaroxaban (Xarelto, BAY59-7939) and Enoxaparin in people with Venous Thromboembolism, run by Bayer at 124 sites in 13 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 BAY59-7939, 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
Venous Thromboembolism
What is being tested?
Rivaroxaban (Xarelto, BAY59-7939) and Enoxaparin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
3,148 participants
Where
124 sitesin 13 countries
Study dates
Jun 2006to Jan 2008
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

  • Male and female patients aged 18 years or above
  • Patients scheduled for elective total knee replacement

Who cannot join

  • Active bleeding or high risk of bleeding contraindicating treatment with Low Molecular Weight Heparin (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

124 sites in 13 countries.

124 sites in 13 countries

United States40 sites

  • Study site

    Bakersfield, California, 93309

  • Study site

    Birmingham, Alabama, 35209

  • Study site

    Boise, Idaho, 83702

  • Study site

    Boynton Beach, Florida, 33472-2952

  • Study site

    Centennial, Colorado, 80112

  • Study site

    Charleston, South Carolina, 29414

  • Study site

    Cincinnati, Ohio, 45242

  • Study site

    Clearwater, Florida, 33756

  • Study site

    Dallas, Texas, 75231

  • Study site

    Decatur, Georgia, 30033

  • Study site

    DeLand, Florida, 32720

  • Study site

    Denver, Colorado, 80230

  • Study site

    Encinitas, California, 92024

  • Study site

    Englewood, Colorado, 80110

  • Study site

    Fountain Valley, California, 92708

  • Study site

    Grapevine, Texas, 76051

  • Study site

    Greensboro, North Carolina, 27401

  • Study site

    Hollywood, Florida, 33021

  • Study site

    Houston, Texas, 77030

  • Study site

    Jacksonville, Florida, 32216

  • Study site

    Johnstown, Pennsylvania, 15901

  • Study site

    La Jolla, California, 92037

  • Study site

    Little Rock, Arkansas, 72205

  • Study site

    Lubbock, Texas, 79410

  • Study site

    Meridian, Idaho, 83642

  • Study site

    Missoula, Montana, 59802

  • Study site

    Oklahoma City, Oklahoma, 73162

  • Study site

    Pensacola, Florida, 32501

  • Study site

    Phoenix, Arizona, 85023

  • Study site

    Pinellas Park, Florida, 33781

  • Study site

    Plano, Texas, 75093

  • Study site

    San Antonio, Texas, 78205

  • Study site

    San Antonio, Texas, 78233

  • Study site

    Spokane, Washington, 99218

  • Study site

    State College, Pennsylvania, 16801

  • Study site

    Teaneck, New Jersey, 07666

  • Study site

    Torrance, California, 90502-2004

  • Study site

    Towson, Maryland, 21204

  • Study site

    Tuscaloosa, Alabama, 35406

  • Study site

    Yuba City, California, 95991

Other trials in United States

Canada18 sites

  • Study site

    Ajax, Ontario, L1S 2J4

  • Study site

    Brantford, Ontario, N3R 1G9

  • Study site

    Charlottetown, Prince Edward Island, C1A 8T5

  • Study site

    Fredericton, New Brunswick, E3B 5N5

  • Study site

    Greater Sudbury, Ontario, P3A 1Y8

  • Study site

    Kelowna, British Columbia, V1W 4V5

  • Study site

    Montreal, Quebec, H3G 1A4

  • Study site

    Montreal, Quebec, H3T 1E2

  • 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

    Red Deer, Alberta, T4N 6V7

  • Study site

    Scarborough Village, Ontario, M1M 3W3

  • Study site

    Scarborough Village, Ontario, M1P 2V5

  • Study site

    Thunder Bay, Ontario, P7B 6V4

  • Study site

    Woodstock, Ontario, N4S 5B2

Other trials in Canada

India14 sites

  • Study site

    Ahmedabad, Gujarat, 380006

  • Study site

    Ahmedabad, Gujarat, 380054

  • Study site

    Bangalore, 560001

  • Study site

    Bangalore, 560034

  • Study site

    Baroda, 390007

  • Study site

    Chennai, Tamil Nadu, 600 006

  • Study site

    Hyderabad, Andhra Pradesh, 500004

  • Study site

    Hyderabad

  • Study site

    Ludhiana, Punjab, 141001

  • Study site

    New Delhi, 110029

  • Study site

    Pune, Maharashtra, 411001

  • Study site

    Pune, Maharashtra, 411009

  • Study site

    Secunderabad, Andhra Pradesh, 500 003

  • Study site

    Secundrabad, Andhra Pradesh, 500003

Other trials in India

Poland10 sites

  • Study site

    Bydgoszcz, 85-094

  • Study site

    Elblag, 82-300

  • Study site

    Gdansk, 80-803

  • Study site

    Gmina Końskie, 26-200

  • Study site

    Kielce

  • Study site

    Krakow, 31-913

  • Study site

    Lublin, 20-718

  • Study site

    Sosnowiec, 41-200

  • Study site

    Warsaw, 02-005

  • Study site

    Warsaw, 02-507

Other trials in Poland

Mexico7 sites

  • Study site

    Edo. de Mexico, 53120

  • Study site

    Guadalajara, Jalisco, 44200

  • Study site

    Guadalajara, Jalisco, 44350

  • Study site

    Mérida, Yucatán, 97150

  • Study site

    Monterrey, Nuevo León, 64000

  • Study site

    Monterrey, Nuevo León, 64380

  • Study site

    Zapopan, Jalisco, 45100

Other trials in Mexico

Denmark6 sites

  • Study site

    Hellerup, DK-2900

  • Study site

    Herlev, 2730

  • Study site

    Hørsholm, 2970

  • Study site

    Hvidovre, 2650

  • Study site

    Silkeborg, 8600

  • Study site

    Viborg, 8800

Other trials in Denmark

Israel6 sites

  • Study site

    Beersheba, 85025

  • Study site

    Holon, 58100

  • Study site

    Kfar Saba, 44281

  • Study site

    Petah Tikva, Israel, 49100

  • Study site

    Tel Aviv, 64239

  • Study site

    Tsrifin, Israel, 70300

Other trials in Israel

Sweden6 sites

  • Study site

    Gothenburg, 416 85

  • Study site

    Hässleholm, 281 25

  • Study site

    Örebro, 701 85

  • Study site

    Stockholm, 112 81

  • Study site

    Västervik, 593 81

  • Study site

    Vaxjo, 351 85

Other trials in Sweden

Lithuania5 sites

  • Study site

    Kaunas, 44320

  • Study site

    Kaunas, LT-50009

  • Study site

    Klaipėda, 92288

  • Study site

    Panevezys, 35144

  • Study site

    Vilnius, LT-04130

Other trials in Lithuania

Norway4 sites

  • Study site

    Baerum Postterminal, 1306

  • Study site

    Gjøvik, 2819

  • Study site

    Kongsvinger, 2212

  • Study site

    Lillehammer, 2609

Other trials in Norway

Bulgaria3 sites

  • Study site

    Pleven, 5800

  • Study site

    Plovdiv, 4002

  • Study site

    Sofia, 1431

Other trials in Bulgaria

Sri Lanka3 sites

  • Study site

    Colombo-80

  • Study site

    Ragama

  • Study site

    Sri Jayewardenepura Kotte

Other trials in Sri Lanka

Pakistan2 sites

  • Study site

    Karachi, Sindh, 74800

  • Study site

    Karachi, Sindh

Other trials in Pakistan

About this study

Official title: RECORD 4 Study: REgulation of Coagulation in ORthopedic Surgery to Prevent DVT and PE; a Controlled, Double-blind, Randomized Study of BAY59-7939 in the Prevention of VTE in Subjects Undergoing Elective Total Knee Replacement

The purpose of this study is to assess if 10 mg BAY59-7939, taken once daily as a tablet, is safe and prevents blood clot which may form after a knee replacement operation.

Being tested
Rivaroxaban (Xarelto, BAY59-7939), Enoxaparin, Placebo: tablet of Rivaroxaban, Placebo: syringes of Enoxaparin
Keywords
Prevention of venous thromboembolism
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 (Xarelto, BAY59-7939)Drug

    Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening.

  • EnoxaparinDrug

    Syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.

  • Placebo: tablet of RivaroxabanDrug

    Placebo tablet of rivaroxaban administered once daily in the evening.

  • Placebo: syringes of EnoxaparinDrug

    Placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.

Study groups in NCT00362232
Study groupRoleWhat they receive
Rivaroxaban 10 mg Once Daily (OD) ((Xarelto, BAY59-7939))ExperimentalRivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.
Receives: Drug: Rivaroxaban (Xarelto, BAY59-7939); Drug: Placebo: syringes of Enoxaparin
Enoxaparin 30 mg twice a day (bid)Active comparatorPlacebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.
Receives: Drug: Enoxaparin; Drug: Placebo: tablet of Rivaroxaban

What is being measured

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

  1. Composite Endpoint of Total Venous Thrombo Embolism (VTE) i.e.: Any Deep Vein Thromboembolism (DVT) (Proximal and/or Distal), Non Fatal Pulmonary Embolism (PE), Death of All Causes Per Protocol Population

    Blinded, adjudicated assessment of bilateral venography, clinical signs of deep vein thrombosis (DVT) and pulmonary embolism (PE), ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography

    Measured: Up to 16 days after surgery

  2. Composite Endpoint of Total VTE i.e.: Any DVT (Proximal and/or Distal), Non Fatal PE, Death of All Causes Per Modified Intent to Treat Population.

    Blinded, adjudicated assessment of bilateral venography, clinical signs of deep vein thrombosis (DVT) and pulmonary embolism (PE), ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography

    Measured: Up to 16 days after surgery

Secondary outcomes (14)

  1. Incidence of the Composite Endpoint Comprising Proximal DVT, Non-fatal PE and VTE- Related Death (Major VTE) Per Protocol Population of Major VTE

    Blinded, adjudicated assessment of bilateral venography, clinical signs of deep vein thrombosis (DVT) and pulmonary embolism (PE), ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography

    Measured: Up to 16 days after surgery

  2. Incidence of the Composite Endpoint Comprising Proximal DVT, Non-fatal PE and VTE- Related Death (Major VTE) Per Modified Intent to Treat Population of Major VTE.

    Blinded, adjudicated assessment of bilateral venography, clinical signs of deep vein thrombosis (DVT) and pulmonary embolism (PE), ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography

    Measured: Up to 16 days after surgery

  3. Incidence of Symptomatic VTE (DVT, PE) Per Protocol Population.

    Blinded, adjudicated assessment of bilateral venography, clinical signs of DVT and PE, ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography

    Measured: Up to 16 days after surgery

  4. Incidence of Symptomatic VTE (DVT, PE) Per Modified Intent to Treat Population.

    Blinded, adjudicated assessment of bilateral venography, clinical signs of DVT and PE, ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography

    Measured: Up to 16 days after surgery

  5. Incidence of DVT (Proximal, Distal) Per Protocol Population.

    Blinded, adjudicated assessment of bilateral venography, clinical signs of DVT and PE, ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography

    Measured: Up to 16 days after surgery

  6. Incidence of DVT (Proximal, Distal) Per Modified Intent to Treat Population.

    Blinded, adjudicated assessment of bilateral venography, clinical signs of DVT and PE, ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography

    Measured: Up to 16 days after surgery

  7. Incidence of Symptomatic VTE During Follow-up Per Protocol Population.

    Blinded, adjudicated assessment of bilateral venography, clinical signs of DVT and PE, ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography

    Measured: Up to 47 days after surgery

  8. Incidence of Symptomatic VTE During Follow-up Per Modified Intent to Treat Population.

    Blinded, adjudicated assessment of bilateral venography, clinical signs of DVT and PE, ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography

    Measured: Up to 47 days after surgery

  9. The Composite Endpoint Comprising Major VTE and Treatment-emergent Major Bleeding Per Subjects Valid for Analysis of Net Clinical Benefit

    Blinded, adjudicated assessment of bilateral venography, clinical signs of DVT and PE, ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography, anesthesia and surgery reports, number of transfusions

    Measured: Up to 47 days after surgery

  10. Incidence of the Composite Endpoint That Results From the Primary Endpoint by Substituting VTE Related Death for All Death Per Protocol Population.

    Blinded, adjudicated assessment of bilateral venography, clinical signs of DVT and PE, ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography

    Measured: Up to 16 days after surgery

  11. Incidence of the Composite Endpoint That Results From the Primary Endpoint by Substituting VTE Related Death for All Death Per Modified Intent to Treat Population.

    Blinded, adjudicated assessment of bilateral venography, clinical signs of DVT and PE, ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography

    Measured: Up to 16 days after surgery

  12. Incidence of the Composite Endpoint That Results From Major VTE by Substituting All Cause Mortality for VTE-related Death Per Protocol of Major VTE Population.

    Blinded, adjudicated assessment of bilateral venography, clinical signs of DVT and PE, ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography

    Measured: Up to 16 days after surgery

  13. Incidence of the Composite Endpoint That Results From Major VTE by Substituting All Cause Mortality for VTE-related Death Per Modified Intent to Treat of Major VTE Population.

    Blinded, adjudicated assessment of bilateral venography, clinical signs of DVT and PE, ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography

    Measured: Up to 16 days after surgery

  14. Treatment-emergent Major Bleedings Per Safety Population.

    Blinded, adjudicated assessments of all available information (eg, anesthesia and surgery reports, laboratory results, number of transfusions, autopsy report)

    Measured: from start of double-blind study medication to last dose of double-blind study medication plus two days. The average duration of double-blind treatment was 12 days in each treatment group (safety population).

Timeline

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

  1. First posted9 Aug 2006 (estimated)
  2. Study startJun 2006
  3. Primary completionJan 2007
  4. Study completionJan 2008

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
3,148 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00362232
Sponsor's protocol ID
11355
Other IDs
2006-002402-60
Acronym
RECORD 4
Status last verified
Oct 2014
First submitted
8 Aug 2006
Last updated
4 Nov 2014
Data monitoring committee
Yes

Publications

  • Turpie AG, Lassen MR, Davidson BL, Bauer KA, Gent M, Kwong LM, Cushner FD, Lotke PA, Berkowitz SD, Bandel TJ, Benson A, Misselwitz F, Fisher WD; RECORD4 Investigators. Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty (RECORD4): a randomised trial. Lancet. 2009 May 16;373(9676):1673-80. doi: 10.1016/S0140-6736(09)60734-0. Epub 2009 May 4.

    PubMed 19411100

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rivaroxaban (Xarelto, BAY59-7939) and Enoxaparin in people with Venous Thromboembolism, run by Bayer at 124 sites in 13 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 3 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 4 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 124 sites in United States, Canada, India, Poland, Mexico and 8 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 13 Jun 2012). 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?

Composite Endpoint of Total Venous Thrombo Embolism (VTE) i.e.: Any Deep Vein Thromboembolism (DVT) (Proximal and/or Distal), Non Fatal Pulmonary Embolism (PE), Death of All Causes Per Protocol Population (time frame: Up to 16 days after surgery). The study lists 2 primary outcomes in all. 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 NCT00362232, 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 4 Nov 2014.

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