Trial Outcomes & Findings for Rivaroxaban vs. Warfarin for Post Cardiac Surgery Atrial Fibrillation (NCT NCT03702582)
NCT ID: NCT03702582
Last Updated: 2026-05-19
Results Overview
Length of inpatient stay in days from time of departure from the operating room
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
100 participants
Primary outcome timeframe
Up to 6 months following the cardiac operation
Results posted on
2026-05-19
Participant Flow
The study was conducted at a large quaternary referral hospital in the United States, and patients were enrolled from April 2019 to June 2023. Patients were screened for enrollment after developing persistent or recurrent atrial fibrillation during their index hospitalization after undergoing an eligible cardiac surgery operation.
No events occurred between enrollment and assignment to a study arm.
Participant milestones
| Measure |
Rivaroxaban
Rivaroxaban: Direct inhibitor of Factor Xa, an enzyme that stimulates the formation of thrombin from prothrombin (A critical step in both the intrinsic and extrinsic aspects of the coagulation cascade)
Dosage form: Per Os (Oral)
Dosage and Frequency: 20 mg every evening with the evening meal (No titration requirements). For patients with decreased glomerular filtration rate (GFR between 15 ml/min and 50 ml/min), dosing will be decreased to 15 mg every evening with the evening meal.
Duration: 30 days (Possibility of continuation after post-operative cardiology clinic visit)
Rivaroxaban: Anticoagulant drug that works via direct inhibition of factor Xa. FDA approved for prophylaxis against stroke in non-valvular atrial fibrillation
|
Warfarin
Warfarin: Competitive inhibitor of vitamin K epoxide reductase complex 1, an important enzyme in the activation pathway for vitamin K dependent coagulation factors
Dosage form: Per Os (Oral)
Dosage and Frequency: Initial dose of 2 - 5 mg nightly after the evening meal (QHS) with appropriate titration to goal INR 2.0 - 3.0 (Initial dose based on weight, age, gender, co-morbidities and concurrent medications). INR will be checked daily to weekly depending on stability of dosing and medication regimen.
Duration: 30 days (Possibility of continuation after post-operative Cardiology clinic visit)
Warfarin: Anticoagulation drug that works via inhibition of vitamin K dependent clotting factors. FDA approved for prophylaxis against stroke in atrial fibrillation
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
|
Overall Study
COMPLETED
|
46
|
45
|
|
Overall Study
NOT COMPLETED
|
4
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Rivaroxaban vs. Warfarin for Post Cardiac Surgery Atrial Fibrillation
Baseline characteristics by cohort
| Measure |
Warfarin
n=50 Participants
Warfarin: Competitive inhibitor of vitamin K epoxide reductase complex 1, an important enzyme in the activation pathway for vitamin K dependent coagulation factors
Dosage form: Per Os (Oral)
Dosage and Frequency: Initial dose of 2 - 5 mg nightly after the evening meal (QHS) with appropriate titration to goal INR 2.0 - 3.0 (Initial dose based on weight, age, gender, co-morbidities and concurrent medications). INR will be checked daily to weekly depending on stability of dosing and medication regimen.
Duration: 30 days (Possibility of continuation after post-operative Cardiology clinic visit)
|
Rivaroxaban
n=50 Participants
Rivaroxaban: Direct inhibitor of Factor Xa, an enzyme that stimulates the formation of thrombin from prothrombin (A critical step in both the intrinsic and extrinsic aspects of the coagulation cascade)
Dosage form: Per Os (Oral)
Dosage and Frequency: 20 mg every evening with the evening meal (No titration requirements). For patients with decreased glomerular filtration rate (GFR between 15 ml/min and 50 ml/min), dosing will be decreased to 15 mg every evening with the evening meal.
Duration: 30 days (Possibility of continuation after post-operative cardiology clinic visit)
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.5 years
STANDARD_DEVIATION 7.3 • n=30 Participants
|
70.1 years
STANDARD_DEVIATION 7.6 • n=30 Participants
|
68.8 years
STANDARD_DEVIATION 7.53 • n=60 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=30 Participants
|
13 Participants
n=30 Participants
|
23 Participants
n=60 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=30 Participants
|
37 Participants
n=30 Participants
|
77 Participants
n=60 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=30 Participants
|
1 Participants
n=30 Participants
|
1 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
White
|
48 Participants
n=30 Participants
|
47 Participants
n=30 Participants
|
95 Participants
n=60 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=30 Participants
|
2 Participants
n=30 Participants
|
4 Participants
n=60 Participants
|
|
Procedure
Coronary Artery Bypass
|
20 Participants
n=30 Participants
|
21 Participants
n=30 Participants
|
41 Participants
n=60 Participants
|
|
Procedure
Aortic Valve Surgery - Repair
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
|
Procedure
Aortic Valve Surgery - Replacement - Biological
|
5 Participants
n=30 Participants
|
8 Participants
n=30 Participants
|
13 Participants
n=60 Participants
|
|
Procedure
Mitral Valve Surgery - Repair
|
5 Participants
n=30 Participants
|
2 Participants
n=30 Participants
|
7 Participants
n=60 Participants
|
|
Procedure
Aortic Root
|
2 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
2 Participants
n=60 Participants
|
|
Procedure
Ascending Aorta - Replacement
|
0 Participants
n=30 Participants
|
1 Participants
n=30 Participants
|
1 Participants
n=60 Participants
|
|
Procedure
Aortic Arch
|
0 Participants
n=30 Participants
|
1 Participants
n=30 Participants
|
1 Participants
n=60 Participants
|
|
Procedure
Combination of Procedures
|
18 Participants
n=30 Participants
|
17 Participants
n=30 Participants
|
35 Participants
n=60 Participants
|
PRIMARY outcome
Timeframe: Up to 6 months following the cardiac operationLength of inpatient stay in days from time of departure from the operating room
Outcome measures
| Measure |
Warfarin
n=50 Participants
Warfarin: Competitive inhibitor of vitamin K epoxide reductase complex 1, an important enzyme in the activation pathway for vitamin K dependent coagulation factors
Dosage form: Per Os (Oral)
Dosage and Frequency: Initial dose of 2 - 5 mg nightly after the evening meal (QHS) with appropriate titration to goal INR 2.0 - 3.0 (Initial dose based on weight, age, gender, co-morbidities and concurrent medications). INR will be checked daily to weekly depending on stability of dosing and medication regimen.
Duration: 30 days (Possibility of continuation after post-operative Cardiology clinic visit)
Warfarin: Anticoagulation drug that works via inhibition of vitamin K dependent clotting factors. FDA approved for prophylaxis against stroke in atrial fibrillation
|
Rivaroxaban
n=50 Participants
Rivaroxaban: Direct inhibitor of Factor Xa, an enzyme that stimulates the formation of thrombin from prothrombin (A critical step in both the intrinsic and extrinsic aspects of the coagulation cascade)
Dosage form: Per Os (Oral)
Dosage and Frequency: 20 mg every evening with the evening meal (No titration requirements). For patients with decreased glomerular filtration rate (GFR between 15 ml/min and 50 ml/min), dosing will be decreased to 15 mg every evening with the evening meal.
Duration: 30 days (Possibility of continuation after post-operative cardiology clinic visit)
Rivaroxaban: Anticoagulant drug that works via direct inhibition of factor Xa. FDA approved for prophylaxis against stroke in non-valvular atrial fibrillation
|
|---|---|---|
|
Postoperative Length of Stay
|
8 days
Interval 6.0 to 9.0
|
7 days
Interval 6.0 to 9.0
|
SECONDARY outcome
Timeframe: Up to 30 days after discharge from the initial postoperative hospitalizationMajor bleeding defined as re-operation or other therapeutic intervention for bleeding (including but not limited to colonoscopy, upper endoscopy and urologic procedures for hematuria), development of any intracranial bleeding, cessation of study drug for bleeding concerns, reversal of study drug for bleeding concerns and/or new transfusion requirement \> 2 units of blood after drug administration
Outcome measures
| Measure |
Warfarin
n=50 Participants
Warfarin: Competitive inhibitor of vitamin K epoxide reductase complex 1, an important enzyme in the activation pathway for vitamin K dependent coagulation factors
Dosage form: Per Os (Oral)
Dosage and Frequency: Initial dose of 2 - 5 mg nightly after the evening meal (QHS) with appropriate titration to goal INR 2.0 - 3.0 (Initial dose based on weight, age, gender, co-morbidities and concurrent medications). INR will be checked daily to weekly depending on stability of dosing and medication regimen.
Duration: 30 days (Possibility of continuation after post-operative Cardiology clinic visit)
Warfarin: Anticoagulation drug that works via inhibition of vitamin K dependent clotting factors. FDA approved for prophylaxis against stroke in atrial fibrillation
|
Rivaroxaban
n=50 Participants
Rivaroxaban: Direct inhibitor of Factor Xa, an enzyme that stimulates the formation of thrombin from prothrombin (A critical step in both the intrinsic and extrinsic aspects of the coagulation cascade)
Dosage form: Per Os (Oral)
Dosage and Frequency: 20 mg every evening with the evening meal (No titration requirements). For patients with decreased glomerular filtration rate (GFR between 15 ml/min and 50 ml/min), dosing will be decreased to 15 mg every evening with the evening meal.
Duration: 30 days (Possibility of continuation after post-operative cardiology clinic visit)
Rivaroxaban: Anticoagulant drug that works via direct inhibition of factor Xa. FDA approved for prophylaxis against stroke in non-valvular atrial fibrillation
|
|---|---|---|
|
Episode of Major Bleeding (Defined as the Occurrence of Any of Several Events Listed in the Description. No Specific Scale, Questionnaire or Instrument Will be Used)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 30 days after discharge from the initial postoperative hospitalizationRates of cerebrovascular accident including stroke and transient ischemic attack (TIA)
Outcome measures
| Measure |
Warfarin
n=50 Participants
Warfarin: Competitive inhibitor of vitamin K epoxide reductase complex 1, an important enzyme in the activation pathway for vitamin K dependent coagulation factors
Dosage form: Per Os (Oral)
Dosage and Frequency: Initial dose of 2 - 5 mg nightly after the evening meal (QHS) with appropriate titration to goal INR 2.0 - 3.0 (Initial dose based on weight, age, gender, co-morbidities and concurrent medications). INR will be checked daily to weekly depending on stability of dosing and medication regimen.
Duration: 30 days (Possibility of continuation after post-operative Cardiology clinic visit)
Warfarin: Anticoagulation drug that works via inhibition of vitamin K dependent clotting factors. FDA approved for prophylaxis against stroke in atrial fibrillation
|
Rivaroxaban
n=50 Participants
Rivaroxaban: Direct inhibitor of Factor Xa, an enzyme that stimulates the formation of thrombin from prothrombin (A critical step in both the intrinsic and extrinsic aspects of the coagulation cascade)
Dosage form: Per Os (Oral)
Dosage and Frequency: 20 mg every evening with the evening meal (No titration requirements). For patients with decreased glomerular filtration rate (GFR between 15 ml/min and 50 ml/min), dosing will be decreased to 15 mg every evening with the evening meal.
Duration: 30 days (Possibility of continuation after post-operative cardiology clinic visit)
Rivaroxaban: Anticoagulant drug that works via direct inhibition of factor Xa. FDA approved for prophylaxis against stroke in non-valvular atrial fibrillation
|
|---|---|---|
|
Cerebrovascular Accident (CVA)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 30 days after discharge from the initial postoperative hospitalizationRates of non-neurological systemic arterial embolism involving any organ system
Outcome measures
| Measure |
Warfarin
n=50 Participants
Warfarin: Competitive inhibitor of vitamin K epoxide reductase complex 1, an important enzyme in the activation pathway for vitamin K dependent coagulation factors
Dosage form: Per Os (Oral)
Dosage and Frequency: Initial dose of 2 - 5 mg nightly after the evening meal (QHS) with appropriate titration to goal INR 2.0 - 3.0 (Initial dose based on weight, age, gender, co-morbidities and concurrent medications). INR will be checked daily to weekly depending on stability of dosing and medication regimen.
Duration: 30 days (Possibility of continuation after post-operative Cardiology clinic visit)
Warfarin: Anticoagulation drug that works via inhibition of vitamin K dependent clotting factors. FDA approved for prophylaxis against stroke in atrial fibrillation
|
Rivaroxaban
n=50 Participants
Rivaroxaban: Direct inhibitor of Factor Xa, an enzyme that stimulates the formation of thrombin from prothrombin (A critical step in both the intrinsic and extrinsic aspects of the coagulation cascade)
Dosage form: Per Os (Oral)
Dosage and Frequency: 20 mg every evening with the evening meal (No titration requirements). For patients with decreased glomerular filtration rate (GFR between 15 ml/min and 50 ml/min), dosing will be decreased to 15 mg every evening with the evening meal.
Duration: 30 days (Possibility of continuation after post-operative cardiology clinic visit)
Rivaroxaban: Anticoagulant drug that works via direct inhibition of factor Xa. FDA approved for prophylaxis against stroke in non-valvular atrial fibrillation
|
|---|---|---|
|
Other Systemic Embolism
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 30 days after discharge from the initial postoperative hospitalizationOccurrence of pathologic venous thrombo-embolism including DVT and PE
Outcome measures
| Measure |
Warfarin
n=50 Participants
Warfarin: Competitive inhibitor of vitamin K epoxide reductase complex 1, an important enzyme in the activation pathway for vitamin K dependent coagulation factors
Dosage form: Per Os (Oral)
Dosage and Frequency: Initial dose of 2 - 5 mg nightly after the evening meal (QHS) with appropriate titration to goal INR 2.0 - 3.0 (Initial dose based on weight, age, gender, co-morbidities and concurrent medications). INR will be checked daily to weekly depending on stability of dosing and medication regimen.
Duration: 30 days (Possibility of continuation after post-operative Cardiology clinic visit)
Warfarin: Anticoagulation drug that works via inhibition of vitamin K dependent clotting factors. FDA approved for prophylaxis against stroke in atrial fibrillation
|
Rivaroxaban
n=50 Participants
Rivaroxaban: Direct inhibitor of Factor Xa, an enzyme that stimulates the formation of thrombin from prothrombin (A critical step in both the intrinsic and extrinsic aspects of the coagulation cascade)
Dosage form: Per Os (Oral)
Dosage and Frequency: 20 mg every evening with the evening meal (No titration requirements). For patients with decreased glomerular filtration rate (GFR between 15 ml/min and 50 ml/min), dosing will be decreased to 15 mg every evening with the evening meal.
Duration: 30 days (Possibility of continuation after post-operative cardiology clinic visit)
Rivaroxaban: Anticoagulant drug that works via direct inhibition of factor Xa. FDA approved for prophylaxis against stroke in non-valvular atrial fibrillation
|
|---|---|---|
|
Deep Venous Thrombosis (DVT) and/or Pulmonary Embolism (PE)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 30 days after discharge from the initial postoperative hospitalizationMinor bleeding defined as blood transfusions \<= 2 units or drop in hemoglobin greater 3g/dL following administration of study drugs
Outcome measures
| Measure |
Warfarin
n=50 Participants
Warfarin: Competitive inhibitor of vitamin K epoxide reductase complex 1, an important enzyme in the activation pathway for vitamin K dependent coagulation factors
Dosage form: Per Os (Oral)
Dosage and Frequency: Initial dose of 2 - 5 mg nightly after the evening meal (QHS) with appropriate titration to goal INR 2.0 - 3.0 (Initial dose based on weight, age, gender, co-morbidities and concurrent medications). INR will be checked daily to weekly depending on stability of dosing and medication regimen.
Duration: 30 days (Possibility of continuation after post-operative Cardiology clinic visit)
Warfarin: Anticoagulation drug that works via inhibition of vitamin K dependent clotting factors. FDA approved for prophylaxis against stroke in atrial fibrillation
|
Rivaroxaban
n=50 Participants
Rivaroxaban: Direct inhibitor of Factor Xa, an enzyme that stimulates the formation of thrombin from prothrombin (A critical step in both the intrinsic and extrinsic aspects of the coagulation cascade)
Dosage form: Per Os (Oral)
Dosage and Frequency: 20 mg every evening with the evening meal (No titration requirements). For patients with decreased glomerular filtration rate (GFR between 15 ml/min and 50 ml/min), dosing will be decreased to 15 mg every evening with the evening meal.
Duration: 30 days (Possibility of continuation after post-operative cardiology clinic visit)
Rivaroxaban: Anticoagulant drug that works via direct inhibition of factor Xa. FDA approved for prophylaxis against stroke in non-valvular atrial fibrillation
|
|---|---|---|
|
Minor Bleeding
|
1 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Up to 30 days after discharge from the initial postoperative hospitalizationPopulation: Twelve participants did not complete the follow-up questionnaire. One participant did not complete the Usual Activities section of the EQ-5D-3L
Participants will be administered the EUROQOL-5D-3L (5 dimensions, 3 levels) questionnaire to derive an estimate of the health state. This is comprised of a 5 questions survey and a single visual analog scale highlighting perceived health levels For the 5 questions survey, each question related to mobility, selfcare, mood, pain and/or functionality is answered on a three point scale with higher number representing worse outcomes. The entire dataset is used to generate a health state based on the unique pattern of answers. These health states are then compared against standardized country-based value sets which provide an assessment of quality of life based on societal preferences.
Outcome measures
| Measure |
Warfarin
n=43 Participants
Warfarin: Competitive inhibitor of vitamin K epoxide reductase complex 1, an important enzyme in the activation pathway for vitamin K dependent coagulation factors
Dosage form: Per Os (Oral)
Dosage and Frequency: Initial dose of 2 - 5 mg nightly after the evening meal (QHS) with appropriate titration to goal INR 2.0 - 3.0 (Initial dose based on weight, age, gender, co-morbidities and concurrent medications). INR will be checked daily to weekly depending on stability of dosing and medication regimen.
Duration: 30 days (Possibility of continuation after post-operative Cardiology clinic visit)
Warfarin: Anticoagulation drug that works via inhibition of vitamin K dependent clotting factors. FDA approved for prophylaxis against stroke in atrial fibrillation
|
Rivaroxaban
n=45 Participants
Rivaroxaban: Direct inhibitor of Factor Xa, an enzyme that stimulates the formation of thrombin from prothrombin (A critical step in both the intrinsic and extrinsic aspects of the coagulation cascade)
Dosage form: Per Os (Oral)
Dosage and Frequency: 20 mg every evening with the evening meal (No titration requirements). For patients with decreased glomerular filtration rate (GFR between 15 ml/min and 50 ml/min), dosing will be decreased to 15 mg every evening with the evening meal.
Duration: 30 days (Possibility of continuation after post-operative cardiology clinic visit)
Rivaroxaban: Anticoagulant drug that works via direct inhibition of factor Xa. FDA approved for prophylaxis against stroke in non-valvular atrial fibrillation
|
|---|---|---|
|
Performance on the EUROQOL (EQ-5D) Quality of Life Instrument
Mobility · No problems
|
35 Participants
|
26 Participants
|
|
Performance on the EUROQOL (EQ-5D) Quality of Life Instrument
Mobility · Some problems
|
8 Participants
|
19 Participants
|
|
Performance on the EUROQOL (EQ-5D) Quality of Life Instrument
Mobility · A lot of problems
|
0 Participants
|
0 Participants
|
|
Performance on the EUROQOL (EQ-5D) Quality of Life Instrument
Self-Care · No problems
|
36 Participants
|
35 Participants
|
|
Performance on the EUROQOL (EQ-5D) Quality of Life Instrument
Self-Care · Some problems
|
7 Participants
|
10 Participants
|
|
Performance on the EUROQOL (EQ-5D) Quality of Life Instrument
Self-Care · A lot of problems
|
0 Participants
|
0 Participants
|
|
Performance on the EUROQOL (EQ-5D) Quality of Life Instrument
Usual Activities · No problems
|
13 Participants
|
18 Participants
|
|
Performance on the EUROQOL (EQ-5D) Quality of Life Instrument
Usual Activities · Some problems
|
21 Participants
|
16 Participants
|
|
Performance on the EUROQOL (EQ-5D) Quality of Life Instrument
Usual Activities · A lot of problems
|
9 Participants
|
10 Participants
|
|
Performance on the EUROQOL (EQ-5D) Quality of Life Instrument
Pain/Discomfort · No problems
|
20 Participants
|
30 Participants
|
|
Performance on the EUROQOL (EQ-5D) Quality of Life Instrument
Pain/Discomfort · Some problems
|
22 Participants
|
15 Participants
|
|
Performance on the EUROQOL (EQ-5D) Quality of Life Instrument
Pain/Discomfort · A lot of problems
|
1 Participants
|
0 Participants
|
|
Performance on the EUROQOL (EQ-5D) Quality of Life Instrument
Anxiety/Depression · No problems
|
36 Participants
|
32 Participants
|
|
Performance on the EUROQOL (EQ-5D) Quality of Life Instrument
Anxiety/Depression · Some problems
|
6 Participants
|
13 Participants
|
|
Performance on the EUROQOL (EQ-5D) Quality of Life Instrument
Anxiety/Depression · A lot of problems
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 30 days after discharge from the initial postoperative hospitalizationPopulation: Twelve participants did not complete the follow-up questionnaire.
Participants will be administered the EUROQOL-5D-3L (5 dimensions, 3 levels) questionnaire to derive an estimate of the health state. This is comprised of a 5 questions survey and a single visual analog scale highlighting perceived health levels For the 5 questions survey, each question related to mobility, selfcare, mood, pain and/or functionality is answered on a three point scale with higher number representing worse outcomes. The entire dataset is used to generate a health state based on the unique pattern of answers. These health states are then compared against standardized country-based value sets which provide an assessment of quality of life based on societal preferences. The visual analog scale is single answer between 0 and 100 representing the patient's perception of their health state. 0 represents the worst health imaginable and 100 represents the best.
Outcome measures
| Measure |
Warfarin
n=43 Participants
Warfarin: Competitive inhibitor of vitamin K epoxide reductase complex 1, an important enzyme in the activation pathway for vitamin K dependent coagulation factors
Dosage form: Per Os (Oral)
Dosage and Frequency: Initial dose of 2 - 5 mg nightly after the evening meal (QHS) with appropriate titration to goal INR 2.0 - 3.0 (Initial dose based on weight, age, gender, co-morbidities and concurrent medications). INR will be checked daily to weekly depending on stability of dosing and medication regimen.
Duration: 30 days (Possibility of continuation after post-operative Cardiology clinic visit)
Warfarin: Anticoagulation drug that works via inhibition of vitamin K dependent clotting factors. FDA approved for prophylaxis against stroke in atrial fibrillation
|
Rivaroxaban
n=45 Participants
Rivaroxaban: Direct inhibitor of Factor Xa, an enzyme that stimulates the formation of thrombin from prothrombin (A critical step in both the intrinsic and extrinsic aspects of the coagulation cascade)
Dosage form: Per Os (Oral)
Dosage and Frequency: 20 mg every evening with the evening meal (No titration requirements). For patients with decreased glomerular filtration rate (GFR between 15 ml/min and 50 ml/min), dosing will be decreased to 15 mg every evening with the evening meal.
Duration: 30 days (Possibility of continuation after post-operative cardiology clinic visit)
Rivaroxaban: Anticoagulant drug that works via direct inhibition of factor Xa. FDA approved for prophylaxis against stroke in non-valvular atrial fibrillation
|
|---|---|---|
|
Performance on the EUROQOL (EQ-5D) Quality of Life Instrument - VAS
|
75 Units on a scale
Interval 63.0 to 80.0
|
75 Units on a scale
Interval 65.0 to 85.0
|
SECONDARY outcome
Timeframe: Up to 30 days after discharge from the initial postoperative hospitalizationPopulation: Twenty-six participants did not complete the follow-up questionnaire.
Participants will be administered the PACT-Q2 questionnaire which is comprised of a convenience subscale and a satisfaction subscale. For the convenience subscale, each of 13 questions is answered on a 1-5 rating scale with higher numbers representing worse outcomes. A sub-scale score is generated by inverting the score from each element and calculating the sum. Range on the inverted scale is 13 - 65. Higher scores represent better outcomes. For the satisfaction subscale, each of 7 questions is answered on a 1-5 rating scale with higher numbers representing better outcomes. The total score on this subscale is generated by adding up scores from all elements. Range on this subscale is 7-35. Higher scores represent better outcomes. A composite score is generated by adding up scores from both subscales and recalibrating on a 0-100 scale by adding the scores together and applying the formula: COMPOSITE SCORE=100×(Sum-20)/80. Higher scores represent more favorable outcomes.
Outcome measures
| Measure |
Warfarin
n=38 Participants
Warfarin: Competitive inhibitor of vitamin K epoxide reductase complex 1, an important enzyme in the activation pathway for vitamin K dependent coagulation factors
Dosage form: Per Os (Oral)
Dosage and Frequency: Initial dose of 2 - 5 mg nightly after the evening meal (QHS) with appropriate titration to goal INR 2.0 - 3.0 (Initial dose based on weight, age, gender, co-morbidities and concurrent medications). INR will be checked daily to weekly depending on stability of dosing and medication regimen.
Duration: 30 days (Possibility of continuation after post-operative Cardiology clinic visit)
Warfarin: Anticoagulation drug that works via inhibition of vitamin K dependent clotting factors. FDA approved for prophylaxis against stroke in atrial fibrillation
|
Rivaroxaban
n=36 Participants
Rivaroxaban: Direct inhibitor of Factor Xa, an enzyme that stimulates the formation of thrombin from prothrombin (A critical step in both the intrinsic and extrinsic aspects of the coagulation cascade)
Dosage form: Per Os (Oral)
Dosage and Frequency: 20 mg every evening with the evening meal (No titration requirements). For patients with decreased glomerular filtration rate (GFR between 15 ml/min and 50 ml/min), dosing will be decreased to 15 mg every evening with the evening meal.
Duration: 30 days (Possibility of continuation after post-operative cardiology clinic visit)
Rivaroxaban: Anticoagulant drug that works via direct inhibition of factor Xa. FDA approved for prophylaxis against stroke in non-valvular atrial fibrillation
|
|---|---|---|
|
Average Score on the Perception of Anticoagulant Treatment Questionnaire (PACT-Q2)
|
83.1 score
Interval 77.5 to 85.0
|
86.9 score
Interval 82.5 to 90.0
|
Adverse Events
Rivaroxaban
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Warfarin
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Rivaroxaban
n=50 participants at risk
Rivaroxaban: Direct inhibitor of Factor Xa, an enzyme that stimulates the formation of thrombin from prothrombin (A critical step in both the intrinsic and extrinsic aspects of the coagulation cascade)
Dosage form: Per Os (Oral)
Dosage and Frequency: 20 mg every evening with the evening meal (No titration requirements). For patients with decreased glomerular filtration rate (GFR between 15 ml/min and 50 ml/min), dosing will be decreased to 15 mg every evening with the evening meal.
Duration: 30 days (Possibility of continuation after post-operative cardiology clinic visit)
Rivaroxaban: Anticoagulant drug that works via direct inhibition of factor Xa. FDA approved for prophylaxis against stroke in non-valvular atrial fibrillation
|
Warfarin
n=50 participants at risk
Warfarin: Competitive inhibitor of vitamin K epoxide reductase complex 1, an important enzyme in the activation pathway for vitamin K dependent coagulation factors
Dosage form: Per Os (Oral)
Dosage and Frequency: Initial dose of 2 - 5 mg nightly after the evening meal (QHS) with appropriate titration to goal INR 2.0 - 3.0 (Initial dose based on weight, age, gender, co-morbidities and concurrent medications). INR will be checked daily to weekly depending on stability of dosing and medication regimen.
Duration: 30 days (Possibility of continuation after post-operative Cardiology clinic visit)
Warfarin: Anticoagulation drug that works via inhibition of vitamin K dependent clotting factors. FDA approved for prophylaxis against stroke in atrial fibrillation
|
|---|---|---|
|
Blood and lymphatic system disorders
Minor bleeding
|
6.0%
3/50 • Patients were followed throughout their hospitalization and for 30 days postdischarge. Follow-up included a phone call from study staff at 2 to 3 weeks after discharge and an in-person cardiac surgery follow-up visit at 30 days after discharge.
No differences in recording of adverse events as defined
|
2.0%
1/50 • Patients were followed throughout their hospitalization and for 30 days postdischarge. Follow-up included a phone call from study staff at 2 to 3 weeks after discharge and an in-person cardiac surgery follow-up visit at 30 days after discharge.
No differences in recording of adverse events as defined
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place