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 (RECORD 2)

January 26, 2015 updated by: Bayer

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2457

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Australian Capital Territory
      • Canberra, Australian Capital Territory, Australia, 2605
    • New South Wales
      • Lismore, New South Wales, Australia, 2480
      • Sydney, New South Wales, Australia, 2065
    • Queensland
      • Southport, Queensland, Australia, 4215
    • Victoria
      • Geelong, Victoria, Australia, 3220
      • Melbourne, Victoria, Australia, 3128
  • Brazil
      • Rio de Janeiro, Brazil
      • Sao Paulo, Brazil, 0122-1020
      • Sao Paulo, Brazil, 04262-000
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30170-132
      • Belo Horizonte, Minas Gerais, Brazil, 30380 090
    • Paraná
      • Curitiba, Paraná, Brazil, 80050-350
    • Rio Grande do Sul
      • Passo Fundo, Rio Grande do Sul, Brazil, 99010-100
    • SP
      • Sao Paulo, SP, Brazil, 04023-900
    • Sao Paulo
      • Batatais, Sao Paulo, Brazil, 14300 000
      • Marília, Sao Paulo, Brazil, 17515-900
  • Canada
    • Alberta
      • Red Deer, Alberta, Canada, T4N 4E7
    • British Columbia
      • Penticton, British Columbia, Canada, V2A 5C8
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3J 3M7
    • New Brunswick
      • St. John, New Brunswick, Canada, E2L 4L2
    • Ontario
      • Oshawa, Ontario, Canada, L1G 2B9
      • Ottawa, Ontario, Canada, K1H 8L6
      • Ottawa, Ontario, Canada, K1Y 4E9
      • Scarborough, Ontario, Canada, M1P 2V5
      • Scarborough, Ontario, Canada, M1M 3W3
      • Thunder Bay, Ontario, Canada, P7B 6V4
      • Windsor, Ontario, Canada, N9A 1E1
  • China
      • Beijing, China, 100044
      • Beijing, China, 100853
      • Beijing, China, 100035
      • Shanghai, China, 200032
      • Shanghai, China, 200233
      • Shanghai, China, 200025
      • Shanghai, China, 200433
    • Guangdong
      • Guangzhou,, Guangdong, China, 510405
    • Shandong
      • Jinan, Shandong, China, 250014
      • Qingdao, Shandong, China, 266003
    • Shanxi
      • Xi'an, Shanxi, China, 710004
  • Colombia
      • Barranquilla, Colombia
      • Bogotá, Colombia
      • Cali, Colombia
      • Medellín, Colombia
  • Denmark
      • Copenhagen, Denmark, 2400
      • Copenhagen, Denmark, 2300
      • Frederiksberg, Denmark, 2000
      • Glostrup, Denmark, 2600
      • Herlev, Denmark, 2730
      • Holbaek, Denmark, 4300
      • Hvidovre, Denmark, 2650
      • Silkeborg, Denmark, 8600
      • Viborg, Denmark, 8800
  • Estonia
      • Tallinn, Estonia, 10138
      • Tartu, Estonia, 51014
  • India
      • Bangalore, India, 560034
      • Bangalore, India, 560001
      • Mumbai, India, 400012
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, India, 500034
    • Andra Pradesh
      • Secundrabad, Andra Pradesh, India, 500003
    • Punjab
      • Ludhiana, Punjab, India, 141001
  • Indonesia
      • Surabaya, Indonesia
    • West Java
      • Bandung, West Java, Indonesia, 40161
  • Italy
      • Genova, Italy, 16132
      • Lecco, Italy, 23900
      • Modena, Italy, 41100
      • Napoli, Italy, 80131
      • Parma, Italy, 43100
      • Siena, Italy, 53100
      • Udine, Italy, 33100
  • Korea, Republic of
      • Daegu, Korea, Republic of, 700721
      • Kyunggido, Korea, Republic of, 471710
      • Seoul, Korea, Republic of, 138-736
      • Seoul, Korea, Republic of, 135-710
  • Latvia
      • Liepaja, Latvia, 3402
      • Riga, Latvia
  • Lithuania
      • Kaunas, Lithuania, 44320
      • Klaipeda, Lithuania, 92288
      • Panevezys, Lithuania, 35144
      • Siauliai, Lithuania, 76231
  • Mexico
    • Chihuahua
      • Chihuahua, Chih., Chihuahua, Mexico, 31000
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44280
  • New Zealand
      • Auckland, New Zealand, 1023
      • Auckland, New Zealand, 0622
  • Norway
      • Kongsvinger, Norway, 2212
      • Namsos, Norway, 7800
      • Oslo, Norway, 0440
      • Oslo, Norway, 0264
      • Tynset, Norway, 2501
  • Peru
      • Callao, Peru, CALLAO 2
      • Lima, Peru, 01
      • Lima, Peru, Lima 11
      • Lima, Peru, 31
      • Lima, Peru, Lima 1
      • Lima Cercado, Peru, LIMA 1
  • Portugal
      • Lisboa, Portugal, 1069-166
      • Porto, Portugal, 4200-319
      • Setúbal, Portugal, 299-182
      • Torres Vedras, Portugal, 2560-324
  • South Africa
    • Freestate
      • Bloemfontein, Freestate, South Africa, 9300
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 2132
      • Randburg, Gauteng, South Africa, 2125
    • Kwa Zulu-Natal
      • Newcastle, Kwa Zulu-Natal, South Africa, 2940
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7505
  • Sweden
      • Falköping, Sweden, 521 85
      • Hässleholm, Sweden, 281 25
      • Kungälv, Sweden, 442 83
      • Lidköping, Sweden, 531 85
      • Stockholm, Sweden, 112 81
      • Sundsvall, Sweden, 851 86
      • Varberg, Sweden, 432 81
      • Växjö, Sweden, 351 85
      • Örebro, Sweden, 701 85
  • Taiwan
      • Kaohsiung, Taiwan, 833
      • Taoyuan, Taiwan, 333
  • United Kingdom
    • Derbyshire
      • Chesterfield, Derbyshire, United Kingdom, S44 5BL
    • Dumfries and Galloway
      • Dumfries, Dumfries and Galloway, United Kingdom, DG1 4EP
    • Fife
      • Kirkcaldy, Fife, United Kingdom, KY2 5AH
    • Greater London
      • London, Greater London, United Kingdom, SE5 9RS
    • Merseyside
      • Liverpool, Merseyside, United Kingdom, L14 3LB
    • Norfolk
      • Great Yarmouth, Norfolk, United Kingdom, NR31 6LA
    • Northamptonshire
      • Northampton, Northamptonshire, United Kingdom, NN1 5BD
    • Surrey
      • Epsom, Surrey, United Kingdom, KT18 7EG
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
    • Colorado
      • Denver, Colorado, United States, 80222
    • Florida
      • Bay Pines, Florida, United States, 33744
      • Miami, Florida, United States, 33186
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Arm 2
Drug: Enoxaparin
40 mg enoxaparin syringe administered for 12 +/- 2 days
Experimental: Arm 1
Drug: Rivaroxaban (BAY59-7939)
10 mg rivaroxaban (tablet) once daily administered for 35 +/- 4 days

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
Treatment period: up to day 35+/-6

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Incidence of the composite endpoint comprising proximal DVT, non-fatal PE and VTE- related death (major VTE)
Time Frame: Treatment period: up to day 35+/-6
Treatment period: up to day 35+/-6
Incidence of symptomatic VTE (DVT, PE)
Time Frame: Treatment period: up to day 35+/-6
Treatment period: up to day 35+/-6
Incidence of DVT (total, proximal, distal)
Time Frame: Treatment period: up to day 35+/-6
Treatment period: up to day 35+/-6
Incidence of symptomatic VTE during follow-up
Time Frame: Follow-up period: following 35+/-6 days
Follow-up period: following 35+/-6 days
The composite endpoint comprising major VTE and treatment-emergent major bleeding
Time Frame: 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
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
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 35+/-6
Treatment period: up to day 35+/-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 35+/-6
Treatment period: up to day 35+/-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
From first dose of double-blind study medication to up to two days after last dose of double-blind study medication

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2006

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2007

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2007

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 30, 2006

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 30, 2006

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 31, 2006

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 27, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 26, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 11357 (DAIDS ES)
  • 2005-004691-20 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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