RECORD 4 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 - RECORD 4

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2006-002402-60-SE
• Date of registration: 28/03/2007
• Prospective Registration: Yes
• Primary sponsor: Bayer Pharmaceutical Corporation
• Public title: RECORD 4 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 - RECORD 4
• Scientific title: RECORD 4 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 - RECORD 4
• Date of first enrolment: 24/05/2007
• Target sample size: 2300
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-002402-60
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no

Countries of recruitment

Bulgaria, Denmark, Lithuania, Sweden

Key inclusion & exclusion criteria

Inclusion criteria:
•Male and female patients aged 18 years or above
•Subjects scheduled for elective total knee replacement
•Subjects' written informed consent for participation after receiving detailed written and oral information prior to any study specific procedures
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
•Active bleeding or high risk of bleeding contraindicating treatment with low molecular weight heparin
•Contraindication listed in the labeling or conditions precluding subjects treatment with enoxaparin or requiring dose adjustment (eg, severe renal impairment)
•Conditions prohibiting bilateral venography (eg, amputation of one leg, allergy to contrast media)
•Pregnant and breast-feeding women. Women with child-bearing potential not using adequate birth control method. (Note: as adequate method of birth control oral contraception is recommended. If oral contraception is not feasible both partners should use adequate barrier birth control).
•Drug- or alcohol abuse
•Concomitant use of human immunodeficiency virus (HIV)-protease inhibitors
•Significant liver disease (eg, acute clinical hepatitis, chronic active hepatitis, cirrhosis)
•Therapy with another investigational product within 30 days prior to start of study
•Planned intermittent pneumatic compression during active treatment period
•Concomitant participation in another trial or study
•Other concomitant medications not allowed (see Section 4.5.7 of the protocol)
•Subjects for whom therapy with anticoagulants cannot be stopped in the opinion of the investigator/physician (eg, phenprocoumon, warfarin-sodium, heparins, and Factor Xa inhibitors other than study medication)


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Prevention of venous thromboembolism
MedDRA version: 8.1 Level: LLT Classification code 10012108 Term: Deep venous thrombosis prophylaxis

Intervention(s)

Product Name: BAY 59-7939
Product Code: BAY 59-7939
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Rivaroxaban
CAS Number: 366789-02-8
Current Sponsor code: BAY 59-7939
Other descriptive name: 5-Chloro-N-({(5S)-2-oxo-3-[4-(3-oxo-4-morpholinyl)phenyl]-1,3-oxazolidin-5-yl}methyl)-2-thiophene...
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Trade Name: Lovenox (enoxaparin sodium injection)
Product Name: Enoxaparin
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Enoxaparin sodium
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 30-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

Primary end point(s): The primary efficacy endpoint is defined as a composite endpoint of:
•Any DVT (proximal and/or distal) and
•Non fatal PE and
•Death from all causes.
The analysis of the primary efficacy endpoint will be solely based on the assessments made by the ICAC and the AC/VTE.

The major secondary efficacy endpoint is:
•Incidence of the composite endpoint comprising proximal DVT, non-fatal PE and VTE-related death (referred to as ‘major VTE’)

Further secondary endpoints are given by:
•Incidence of DVT (total, proximal, distal)
•Incidence of symptomatic VTE (DVT, PE)
•Incidence of symptomatic VTE during follow-up (i.e. after the end of the time window for primary efficacy assessment).
•'Net clinical benefit' assessed by the composite endpoint comprising major VTE and treatment-emergent major bleeding (as defined in Section 4.6.2)
•Incidence of the composite endpoint that results from the primary endpoint by substituting VTE related death for all death (composite of any DVT [proximal and/or distal] and nonfatal PE and VTE-related death)
•Incidence of the composite endpoint that results from major VTE by substituting all cause mortality for VTE-related death (composite of proximal DVT and nonfatal PE and death from all causes)
The analysis of the secondary efficacy endpoints related to VTE will be solely based on the assessments made by the ICAC and AC/VTE.

Secondary Objective: A further study endpoint is health care resource utilization, assessed by duration of hospitalization, any re-hospitalization during the entire study period, and rehabilitation center stay following hospital discharge.

Main Objective: The objective is to assess the efficacy and safety of BAY 59-7939 10 mg once daily dosing in prevention of VTE in men and women aged 18 years or above undergoing elective total knee replacement.

Secondary ID(s)

BAY 59-7939/11355

2006-002402-60-BG