Trial Outcomes & Findings for 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 (NCT NCT01094886)

NCT ID: NCT01094886

Last Updated: 2017-03-17

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 56 participants
• Primary outcome timeframe: Day 1, Day 3
• Results posted on: 2017-03-17

Participant Flow

Participant milestones

Measure	Rivaroxaban 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)
Overall Study STARTED	53
Overall Study COMPLETED	46
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Measure	Rivaroxaban 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)
Overall Study Adverse Event	2
Overall Study Withdrawal by Subject	5

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Rivaroxaban n=53 Participants 10 mg PO qd for up to 35 days for THR and 14 days for TKR
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants
Age, Categorical >=65 years	41 Participants n=5 Participants
Age, Continuous	70.5 years STANDARD_DEVIATION 11.14 • n=5 Participants
Sex: Female, Male Female	29 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants
Region of Enrollment UNITED STATES	53 participants n=5 Participants
Surgical Type Hip	26 participants n=5 Participants
Surgical Type Knee	27 participants n=5 Participants
Baseline BMI	29.5 kg/m^2 STANDARD_DEVIATION 6.78 • n=5 Participants
Baseline Estimated Glomerular Filtration Rate (eGFR) From Local Lab eGFR >= 60 mL/min	47 participants n=5 Participants
Baseline Estimated Glomerular Filtration Rate (eGFR) From Local Lab eGFR Between 30 and 59 mL/min	6 participants n=5 Participants
Ethnicity Hispanic or Latino	1 participants n=5 Participants
Ethnicity Not Hispanic or Latino	52 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1, Day 3

Population: ITT population: All subjects who received study drug and had valid post-dose data collected for efficacy analysis.

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

Outcome measures

Measure	Rivaroxaban n=52 Participants 10 mg PO qd for up to 35 days for THR and 14 days for TKR
Summary of Change From Day 3 to Day 1 in Maximum Anti-Factor Xa (aFXa) Day 1	1.66 IU/ml Standard Deviation 0.422
Summary of Change From Day 3 to Day 1 in Maximum Anti-Factor Xa (aFXa) Day 3	1.83 IU/ml Standard Deviation 0.305

PRIMARY outcome

Timeframe: Day 1, Day 3

Population: ITT population: All subjects who received study drug and had valid post-dose data collected for efficacy analysis

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

Outcome measures

Measure	Rivaroxaban n=52 Participants 10 mg PO qd for up to 35 days for THR and 14 days for TKR
Summary of Change From Day 3 to Day 1 in Maximum Prothrombin Time Day 1	21.57 sec Standard Deviation 3.405
Summary of Change From Day 3 to Day 1 in Maximum Prothrombin Time Day 3	20.51 sec Standard Deviation 3.179

SECONDARY outcome

Timeframe: Day 1, Day 3

Population: ITT population: All subjects who received study drug and had valid post-dose data collected for efficacy analysis

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

Outcome measures

Measure	Rivaroxaban n=52 Participants 10 mg PO qd for up to 35 days for THR and 14 days for TKR
Summary of Change From Day 1 to Day 3 in Area Under the Curve (AUC) of aFXa Day 1	21.35 IU/ml*hour Standard Deviation 7.086
Summary of Change From Day 1 to Day 3 in Area Under the Curve (AUC) of aFXa Day 3	20.74 IU/ml*hour Standard Deviation 7.17

SECONDARY outcome

Timeframe: Day 1, Day 3

Population: ITT population: All subjects who received study drug and had valid post-dose data collected for efficacy analysis

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

Outcome measures

Measure	Rivaroxaban n=52 Participants 10 mg PO qd for up to 35 days for THR and 14 days for TKR
Summary of Change From Day 1 to Day 3 in AUC of Prothrombin Time Day 1	420.46 sec*hour Standard Deviation 44.361
Summary of Change From Day 1 to Day 3 in AUC of Prothrombin Time Day 3	391.37 sec*hour Standard Deviation 42.664

Adverse Events

Rivaroxaban

Serious events: 3 serious events

Other events: 38 other events

Deaths: 0 deaths

Serious adverse events

Measure	Rivaroxaban n=53 participants at risk 10 mg PO qd for up to 35 days for THR and 14 days for TKR
Infections and infestations Arthritis Infective	1.9% 1/53 • 30 days From the first dose day to the final evaluation day.
Injury, poisoning and procedural complications Lumbar Vertebral Fracture	1.9% 1/53 • 30 days From the first dose day to the final evaluation day.
Psychiatric disorders Anxiety	1.9% 1/53 • 30 days From the first dose day to the final evaluation day.

Other adverse events

Measure	Rivaroxaban n=53 participants at risk 10 mg PO qd for up to 35 days for THR and 14 days for TKR
Gastrointestinal disorders Constipation	22.6% 12/53 • 30 days From the first dose day to the final evaluation day.
Gastrointestinal disorders Nausea	17.0% 9/53 • 30 days From the first dose day to the final evaluation day.
General disorders Asthenia	13.2% 7/53 • 30 days From the first dose day to the final evaluation day.
General disorders Pyrexia	13.2% 7/53 • 30 days From the first dose day to the final evaluation day.
General disorders Oedema	7.5% 4/53 • 30 days From the first dose day to the final evaluation day.
Investigations Blood Iron Decreased	9.4% 5/53 • 30 days From the first dose day to the final evaluation day.
Musculoskeletal and connective tissue disorders Muscle Spasms	9.4% 5/53 • 30 days From the first dose day to the final evaluation day.
Psychiatric disorders Insomnia	9.4% 5/53 • 30 days From the first dose day to the final evaluation day.
Injury, poisoning and procedural complications Fall	5.7% 3/53 • 30 days From the first dose day to the final evaluation day.
Surgical and medical procedures Transfusion	5.7% 3/53 • 30 days From the first dose day to the final evaluation day.

Additional Information

VP Medical Affairs, Internal Medicine

Janssen Scientific Affairs, LLC

Phone: 1 908 218-7250

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60