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Switching Drug Therapy for the Prevention of Blood Clot Formation From Enoxaparin to Rivaroxaban After Orthopedic Surgery for Either Total Hip or Total Knee Replacement

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ClinicalTrials.gov Identifier: NCT01094886
Recruitment Status : Completed
First Posted : March 29, 2010
Results First Posted : February 27, 2012
Last Update Posted : March 17, 2017
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Ortho-McNeil Janssen Scientific Affairs, LLC

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Arthritis
Osteoarthritis, Knee
Osteoarthritis, Hip
Thromboembolism
Intervention Drug: Rivaroxaban
Enrollment 56
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Rivaroxaban
Hide Arm/Group Description 10 mg PO (orally) qd (once daily) for up to 35 days for total hip replacement (THR) and 14 days for total knee replacement (TKR)
Period Title: Overall Study
Started 53
Completed 46
Not Completed 7
Reason Not Completed
Adverse Event             2
Withdrawal by Subject             5
Arm/Group Title Rivaroxaban
Hide Arm/Group Description 10 mg PO qd for up to 35 days for THR and 14 days for TKR
Overall Number of Baseline Participants 53
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 53 participants
<=18 years
0
   0.0%
Between 18 and 65 years
12
  22.6%
>=65 years
41
  77.4%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 53 participants
70.5  (11.14)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 53 participants
Female
29
  54.7%
Male
24
  45.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
UNITED STATES Number Analyzed 53 participants
53
Surgical Type  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 53 participants
Hip 26
Knee 27
Baseline BMI  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 53 participants
29.5  (6.78)
Baseline Estimated Glomerular Filtration Rate (eGFR) From Local Lab  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 53 participants
eGFR >= 60 mL/min 47
eGFR Between 30 and 59 mL/min 6
Ethnicity  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 53 participants
Hispanic or Latino 1
Not Hispanic or Latino 52
1.Primary Outcome
Title Summary of Change From Day 3 to Day 1 in Maximum Anti-Factor Xa (aFXa)
Hide Description Descriptive statistics for per-patient maximum Anti-Factor Xa laboratory value selected from the 7 consecutive blood draws (0, 2, 4, 6, 8, 12 and 24 hrs post dose) on Day 1 and Day 3
Time Frame Day 1, Day 3
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population: All subjects who received study drug and had valid post-dose data collected for efficacy analysis.
Arm/Group Title Rivaroxaban
Hide Arm/Group Description:
10 mg PO qd for up to 35 days for THR and 14 days for TKR
Overall Number of Participants Analyzed 52
Mean (Standard Deviation)
Unit of Measure: IU/ml
Day 1 1.66  (0.422)
Day 3 1.83  (0.305)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rivaroxaban
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .008
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.20
Confidence Interval (2-Sided) 95%
-0.05 to 0.34
Parameter Dispersion
Type: Standard Deviation
Value: 0.5
Estimation Comments [Not Specified]
2.Primary Outcome
Title Summary of Change From Day 3 to Day 1 in Maximum Prothrombin Time
Hide Description Descriptive statistics for per-patient maximum prothrombin time laboratory value selected from the 7 consecutive blood draws (0, 2, 4, 6, 8, 12 and 24 hrs post dose) on Day 1 and Day 3
Time Frame Day 1, Day 3
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population: All subjects who received study drug and had valid post-dose data collected for efficacy analysis
Arm/Group Title Rivaroxaban
Hide Arm/Group Description:
10 mg PO qd for up to 35 days for THR and 14 days for TKR
Overall Number of Participants Analyzed 52
Mean (Standard Deviation)
Unit of Measure: sec
Day 1 21.57  (3.405)
Day 3 20.51  (3.179)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rivaroxaban
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.111
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.91
Confidence Interval (2-Sided) 95%
-2.048 to 0.219
Parameter Dispersion
Type: Standard Deviation
Value: -1.10
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Summary of Change From Day 1 to Day 3 in Area Under the Curve (AUC) of aFXa
Hide Description Descriptive statistics for Area Under the Curve (AUC) on Study Day 1 and Day 3 for Anti-Factor Xa, based on the 7 consecutive blood draws at 0, 2, 4, 6, 8, 12 and 24 hours post dose
Time Frame Day 1, Day 3
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population: All subjects who received study drug and had valid post-dose data collected for efficacy analysis
Arm/Group Title Rivaroxaban
Hide Arm/Group Description:
10 mg PO qd for up to 35 days for THR and 14 days for TKR
Overall Number of Participants Analyzed 52
Mean (Standard Deviation)
Unit of Measure: IU/ml*hour
Day 1 21.35  (7.086)
Day 3 20.74  (7.17)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rivaroxaban
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.87
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.21
Confidence Interval (2-Sided) 95%
-2.77 to 2.35
Parameter Dispersion
Type: Standard Deviation
Value: 6.977
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Summary of Change From Day 1 to Day 3 in AUC of Prothrombin Time
Hide Description Descriptive statistics for AUC on Study Day 1 and Day 3 for prothrombin time, based on the 7 consecutive blood draws at 0, 2, 4, 6, 8, 12 and 24 hours post dose
Time Frame Day 1, Day 3
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population: All subjects who received study drug and had valid post-dose data collected for efficacy analysis
Arm/Group Title Rivaroxaban
Hide Arm/Group Description:
10 mg PO qd for up to 35 days for THR and 14 days for TKR
Overall Number of Participants Analyzed 52
Mean (Standard Deviation)
Unit of Measure: sec*hour
Day 1 420.46  (44.361)
Day 3 391.37  (42.664)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rivaroxaban
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -35.13
Confidence Interval (2-Sided) 95%
-48.01 to -22.26
Parameter Dispersion
Type: Standard Deviation
Value: 36.316
Estimation Comments [Not Specified]
Time Frame 30 days
Adverse Event Reporting Description From the first dose day to the final evaluation day.
 
Arm/Group Title Rivaroxaban
Hide Arm/Group Description 10 mg PO qd for up to 35 days for THR and 14 days for TKR
All-Cause Mortality
Rivaroxaban
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Rivaroxaban
Affected / at Risk (%)
Total   3/53 (5.66%) 
Infections and infestations   
Arthritis Infective * 1  1/53 (1.89%) 
Injury, poisoning and procedural complications   
Lumbar Vertebral Fracture * 1  1/53 (1.89%) 
Psychiatric disorders   
Anxiety * 1  1/53 (1.89%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 13.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Rivaroxaban
Affected / at Risk (%)
Total   38/53 (71.70%) 
Gastrointestinal disorders   
Constipation * 1  12/53 (22.64%) 
Nausea * 1  9/53 (16.98%) 
General disorders   
Asthenia * 1  7/53 (13.21%) 
Pyrexia * 1  7/53 (13.21%) 
Oedema * 1  4/53 (7.55%) 
Injury, poisoning and procedural complications   
Fall * 1  3/53 (5.66%) 
Investigations   
Blood Iron Decreased * 1  5/53 (9.43%) 
Musculoskeletal and connective tissue disorders   
Muscle Spasms * 1  5/53 (9.43%) 
Psychiatric disorders   
Insomnia * 1  5/53 (9.43%) 
Surgical and medical procedures   
Transfusion * 1  3/53 (5.66%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 13.0
There were 56 subjects enrolled in the study, but only 53 of them were treated with study medication.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: VP Medical Affairs, Internal Medicine
Organization: Janssen Scientific Affairs, LLC
Phone: 1 908 218-7250
Responsible Party: Ortho-McNeil Janssen Scientific Affairs, LLC
ClinicalTrials.gov Identifier: NCT01094886     History of Changes
Other Study ID Numbers: CR016531
RIVAROXCPK3001 ( Other Identifier: Ortho-McNeil Janssen Scientific Affairs, LLC )
First Submitted: March 25, 2010
First Posted: March 29, 2010
Results First Submitted: December 1, 2011
Results First Posted: February 27, 2012
Last Update Posted: March 17, 2017