Trial Outcomes & Findings for A Study Exploring Two Treatment Strategies in Patients With Atrial Fibrillation Who Undergo Catheter Ablation Therapy (NCT NCT01729871)
NCT ID: NCT01729871
Last Updated: 2017-03-06
Results Overview
Post-procedure major bleeding events include Thrombolysis in Myocardial Infarction (TIMI), International Society on Thrombosis and Haemostasis (ISTH) and Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) Severe/life threatening bleeding.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
253 participants
Primary outcome timeframe
Up to 30 plus or minus (+-) 5 days after the catheter ablation procedure
Results posted on
2017-03-06
Participant Flow
Participants were randomized at 37 sites in 5 countries.
248 participants were randomized correctly to study, with an equal number of participants randomized to both treatment arms. The intention to treat (ITT) analysis set includes all participants who were correctly randomized into study. There are 5 screen failures who were not included in ITT analysis set because they were incorrectly randomized.
Participant milestones
| Measure |
Rivaroxaban
Participants were received Rivaroxaban 20 milligram (mg) orally once-daily administered preferably with the evening meal for 8-10 weeks.
|
Vitamin K Antagonist
Participants were received dose-adjusted vitamin K antagonist (VKA) to achieve a recommended International Normalized Ratio (INR) of 2.0 to 3.0 for 8-10 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
124
|
124
|
|
Overall Study
COMPLETED
|
112
|
101
|
|
Overall Study
NOT COMPLETED
|
12
|
23
|
Reasons for withdrawal
| Measure |
Rivaroxaban
Participants were received Rivaroxaban 20 milligram (mg) orally once-daily administered preferably with the evening meal for 8-10 weeks.
|
Vitamin K Antagonist
Participants were received dose-adjusted vitamin K antagonist (VKA) to achieve a recommended International Normalized Ratio (INR) of 2.0 to 3.0 for 8-10 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
7
|
7
|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
|
Overall Study
Physician Decision
|
0
|
2
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
3
|
|
Overall Study
Other
|
4
|
9
|
Baseline Characteristics
A Study Exploring Two Treatment Strategies in Patients With Atrial Fibrillation Who Undergo Catheter Ablation Therapy
Baseline characteristics by cohort
| Measure |
Rivaroxaban
n=124 Participants
Participants were received Rivaroxaban 20 milligram (mg) orally once-daily administered preferably with the evening meal for 8-10 weeks.
|
Vitamin K Antagonist
n=124 Participants
Participants were received dose-adjusted vitamin K antagonist (VKA) to achieve a recommended International Normalized Ratio (INR) of 2.0 to 3.0 for 8-10 weeks.
|
Total
n=248 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.6 years
STANDARD_DEVIATION 9.86 • n=5 Participants
|
60.5 years
STANDARD_DEVIATION 10.51 • n=7 Participants
|
59.5 years
STANDARD_DEVIATION 10.21 • n=5 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
86 Participants
n=5 Participants
|
90 Participants
n=7 Participants
|
176 Participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
24 participants
n=5 Participants
|
24 participants
n=7 Participants
|
48 participants
n=5 Participants
|
|
Region of Enrollment
France
|
19 participants
n=5 Participants
|
19 participants
n=7 Participants
|
38 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
18 participants
n=5 Participants
|
19 participants
n=7 Participants
|
37 participants
n=5 Participants
|
|
Region of Enrollment
Great Britain
|
24 participants
n=5 Participants
|
24 participants
n=7 Participants
|
48 participants
n=5 Participants
|
|
Region of Enrollment
United States of America
|
39 participants
n=5 Participants
|
38 participants
n=7 Participants
|
77 participants
n=5 Participants
|
|
Race
ASIAN
|
5 participants
n=5 Participants
|
2 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Race
BLACK
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Race
N/A
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Race
WHITE
|
112 participants
n=5 Participants
|
116 participants
n=7 Participants
|
228 participants
n=5 Participants
|
|
Ethnicity
HISPANIC/LATINO
|
0 participants
n=5 Participants
|
4 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Ethnicity
N/A
|
34 participants
n=5 Participants
|
26 participants
n=7 Participants
|
60 participants
n=5 Participants
|
|
Ethnicity
NOT HISPANIC/LATINO
|
90 participants
n=5 Participants
|
94 participants
n=7 Participants
|
184 participants
n=5 Participants
|
|
Body-Mass Index
|
29.8 kg/m^2
STANDARD_DEVIATION 5.74 • n=5 Participants
|
28.9 kg/m^2
STANDARD_DEVIATION 5.49 • n=7 Participants
|
29.4 kg/m^2
STANDARD_DEVIATION 5.62 • n=5 Participants
|
|
Diastolic Blood Pressure
|
81 mmHg
STANDARD_DEVIATION 9.85 • n=5 Participants
|
79.4 mmHg
STANDARD_DEVIATION 10.78 • n=7 Participants
|
80.2 mmHg
STANDARD_DEVIATION 10.34 • n=5 Participants
|
|
Systolic Blood Pressure
|
133.3 mmHg
STANDARD_DEVIATION 15.6 • n=5 Participants
|
131.2 mmHg
STANDARD_DEVIATION 17.68 • n=7 Participants
|
132.2 mmHg
STANDARD_DEVIATION 16.67 • n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 30 plus or minus (+-) 5 days after the catheter ablation procedurePopulation: Per-protocol analysis set included all randomized participants who took at least 1 dose of study drug and had undergone the catheter ablation procedure.
Post-procedure major bleeding events include Thrombolysis in Myocardial Infarction (TIMI), International Society on Thrombosis and Haemostasis (ISTH) and Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) Severe/life threatening bleeding.
Outcome measures
| Measure |
Rivaroxaban
n=114 Participants
Participants were received Rivaroxaban 20 milligram (mg) orally once-daily administered preferably with the evening meal for 8-10 weeks.
|
Vitamin K Antagonist
n=107 Participants
Participants were received dose-adjusted vitamin K antagonist (VKA) to achieve a recommended International Normalized Ratio (INR) of 2.0 to 3.0 for 8-10 weeks.
|
|---|---|---|
|
Number of Participants With Incidence of Post-Procedure Major Bleeding Events
TIMI Major Bleeding
|
0 Participants
|
0 Participants
|
|
Number of Participants With Incidence of Post-Procedure Major Bleeding Events
ISTH Major Bleeding
|
0 Participants
|
1 Participants
|
|
Number of Participants With Incidence of Post-Procedure Major Bleeding Events
GUSTO Severe/Life Threatening Bleeding
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 30 plus or minus (+-) 5 days after the catheter ablation procedurePopulation: Per-protocol analysis set included all randomized participants who took at least 1 dose of study drug and had undergone the catheter ablation procedure.
The composite endpoint include Myocardial Infarction (MI), Ischemic Stroke, Non-Central Nervous System (non-CNS) Systemic Embolism and Vascular Death.
Outcome measures
| Measure |
Rivaroxaban
n=114 Participants
Participants were received Rivaroxaban 20 milligram (mg) orally once-daily administered preferably with the evening meal for 8-10 weeks.
|
Vitamin K Antagonist
n=107 Participants
Participants were received dose-adjusted vitamin K antagonist (VKA) to achieve a recommended International Normalized Ratio (INR) of 2.0 to 3.0 for 8-10 weeks.
|
|---|---|---|
|
Number of Participants With Composite Endpoint of Myocardial Infarction (MI), Ischemic Stroke, Non-Central Nervous System (Non-CNS) Systemic Embolism and Vascular Death
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to 30 plus or minus (+-) 5 days after the catheter ablation procedurePopulation: Per-protocol analysis set included all randomized participants who took at least 1 dose of study drug and had undergone the catheter ablation procedure.
The MI was defined as clinical symptoms consistent with myocardial ischemia and cardiac biomarker elevation greater than the site's upper limit of normal (ULN) or development of new pathological Q waves in at least 2 contiguous leads on the electrocardiogram (ECG) or autopsy confirmation, OR Creatine kinase-muscle and brain subunit \[or creatine kinase (CK) in the absence of CK-MB\] greater than (\>) 3 or 5 or 10 x ULN for samples obtained within 24 hours of the procedure if the baseline values were normal or at least a 50 percent (%) increase over elevated baseline values that were stable or decreasing or development of new pathological Q waves in at least 2 contiguous leads on the electrocardiogram. Symptoms of cardiac ischemia were not required.
Outcome measures
| Measure |
Rivaroxaban
n=114 Participants
Participants were received Rivaroxaban 20 milligram (mg) orally once-daily administered preferably with the evening meal for 8-10 weeks.
|
Vitamin K Antagonist
n=107 Participants
Participants were received dose-adjusted vitamin K antagonist (VKA) to achieve a recommended International Normalized Ratio (INR) of 2.0 to 3.0 for 8-10 weeks.
|
|---|---|---|
|
Number of Participants With Myocardial Infarction (MI)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 30 plus or minus (+-) 5 days after the catheter ablation procedurePopulation: Per-protocol analysis set included all randomized participants who took at least 1 dose of study drug and had undergone the catheter ablation procedure.
Stroke was defined as a new, sudden, focal neurological deficit resulting from a presumed cerebrovascular cause that was not reversible within 24 hours and not due to a readily identifiable cause such as a tumor or seizure.
Outcome measures
| Measure |
Rivaroxaban
n=114 Participants
Participants were received Rivaroxaban 20 milligram (mg) orally once-daily administered preferably with the evening meal for 8-10 weeks.
|
Vitamin K Antagonist
n=107 Participants
Participants were received dose-adjusted vitamin K antagonist (VKA) to achieve a recommended International Normalized Ratio (INR) of 2.0 to 3.0 for 8-10 weeks.
|
|---|---|---|
|
Number of Participants With Ischemic Stroke
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 30 plus or minus (+-) 5 days after the catheter ablation procedurePopulation: Per-protocol analysis set included all randomized participants who took at least 1 dose of study drug and had undergone the catheter ablation procedure.
The Non-CNS systemic embolism was defined as abrupt vascular insufficiency associated with clinical or radiological evidence of arterial occlusion in the absence of other likely mechanisms, (example; trauma, atherosclerosis, instrumentation).
Outcome measures
| Measure |
Rivaroxaban
n=114 Participants
Participants were received Rivaroxaban 20 milligram (mg) orally once-daily administered preferably with the evening meal for 8-10 weeks.
|
Vitamin K Antagonist
n=107 Participants
Participants were received dose-adjusted vitamin K antagonist (VKA) to achieve a recommended International Normalized Ratio (INR) of 2.0 to 3.0 for 8-10 weeks.
|
|---|---|---|
|
Number of Participants With Non-Central Nervous System (Non-CNS) Systemic Embolism
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 30 plus or minus (+-) 5 days after the catheter ablation procedurePopulation: Per-protocol analysis set included all randomized participants who took at least 1 dose of study drug and had undergone the catheter ablation procedure.
Any death that was not clearly non-vascular. Examples of vascular death included deaths due to bleeding, Myocardial Infarction (MI), stroke, heart failure and arrhythmias.
Outcome measures
| Measure |
Rivaroxaban
n=114 Participants
Participants were received Rivaroxaban 20 milligram (mg) orally once-daily administered preferably with the evening meal for 8-10 weeks.
|
Vitamin K Antagonist
n=107 Participants
Participants were received dose-adjusted vitamin K antagonist (VKA) to achieve a recommended International Normalized Ratio (INR) of 2.0 to 3.0 for 8-10 weeks.
|
|---|---|---|
|
Number of Participants With Vascular Death
|
0 Participants
|
1 Participants
|
Adverse Events
Rivaroxaban
Serious events: 17 serious events
Other events: 26 other events
Deaths: 0 deaths
Vitamin K Antagonist
Serious events: 20 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Rivaroxaban
n=123 participants at risk
Participants were received Rivaroxaban 20 milligram (mg) orally once-daily administered preferably with the evening meal for 8-10 weeks.
|
Vitamin K Antagonist
n=121 participants at risk
Participants were received dose-adjusted vitamin K antagonist (VKA) to achieve a recommended International Normalized Ratio (INR) of 2.0 to 3.0 for 8-10 weeks.
|
|---|---|---|
|
General disorders
Asthenia
|
0.00%
0/123 • Screening up to Week 8-10
The overall treatment-emergent adverse event (TEAEs), serious adverse events, and adverse events leading to discontinuation are based on 244 participants who were randomized and received at least 1 dose of study drug.
|
0.83%
1/121 • Screening up to Week 8-10
The overall treatment-emergent adverse event (TEAEs), serious adverse events, and adverse events leading to discontinuation are based on 244 participants who were randomized and received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/123 • Screening up to Week 8-10
The overall treatment-emergent adverse event (TEAEs), serious adverse events, and adverse events leading to discontinuation are based on 244 participants who were randomized and received at least 1 dose of study drug.
|
0.83%
1/121 • Screening up to Week 8-10
The overall treatment-emergent adverse event (TEAEs), serious adverse events, and adverse events leading to discontinuation are based on 244 participants who were randomized and received at least 1 dose of study drug.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/123 • Screening up to Week 8-10
The overall treatment-emergent adverse event (TEAEs), serious adverse events, and adverse events leading to discontinuation are based on 244 participants who were randomized and received at least 1 dose of study drug.
|
0.83%
1/121 • Screening up to Week 8-10
The overall treatment-emergent adverse event (TEAEs), serious adverse events, and adverse events leading to discontinuation are based on 244 participants who were randomized and received at least 1 dose of study drug.
|
|
Cardiac disorders
Atrial fibrillation
|
2.4%
3/123 • Screening up to Week 8-10
The overall treatment-emergent adverse event (TEAEs), serious adverse events, and adverse events leading to discontinuation are based on 244 participants who were randomized and received at least 1 dose of study drug.
|
4.1%
5/121 • Screening up to Week 8-10
The overall treatment-emergent adverse event (TEAEs), serious adverse events, and adverse events leading to discontinuation are based on 244 participants who were randomized and received at least 1 dose of study drug.
|
|
Cardiac disorders
Atrial flutter
|
0.81%
1/123 • Screening up to Week 8-10
The overall treatment-emergent adverse event (TEAEs), serious adverse events, and adverse events leading to discontinuation are based on 244 participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/121 • Screening up to Week 8-10
The overall treatment-emergent adverse event (TEAEs), serious adverse events, and adverse events leading to discontinuation are based on 244 participants who were randomized and received at least 1 dose of study drug.
|
|
Cardiac disorders
Atrial tachycardia
|
0.00%
0/123 • Screening up to Week 8-10
The overall treatment-emergent adverse event (TEAEs), serious adverse events, and adverse events leading to discontinuation are based on 244 participants who were randomized and received at least 1 dose of study drug.
|
0.83%
1/121 • Screening up to Week 8-10
The overall treatment-emergent adverse event (TEAEs), serious adverse events, and adverse events leading to discontinuation are based on 244 participants who were randomized and received at least 1 dose of study drug.
|
|
Cardiac disorders
Bradycardia
|
1.6%
2/123 • Screening up to Week 8-10
The overall treatment-emergent adverse event (TEAEs), serious adverse events, and adverse events leading to discontinuation are based on 244 participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/121 • Screening up to Week 8-10
The overall treatment-emergent adverse event (TEAEs), serious adverse events, and adverse events leading to discontinuation are based on 244 participants who were randomized and received at least 1 dose of study drug.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/123 • Screening up to Week 8-10
The overall treatment-emergent adverse event (TEAEs), serious adverse events, and adverse events leading to discontinuation are based on 244 participants who were randomized and received at least 1 dose of study drug.
|
0.83%
1/121 • Screening up to Week 8-10
The overall treatment-emergent adverse event (TEAEs), serious adverse events, and adverse events leading to discontinuation are based on 244 participants who were randomized and received at least 1 dose of study drug.
|
|
Cardiac disorders
Pericarditis
|
0.81%
1/123 • Screening up to Week 8-10
The overall treatment-emergent adverse event (TEAEs), serious adverse events, and adverse events leading to discontinuation are based on 244 participants who were randomized and received at least 1 dose of study drug.
|
0.83%
1/121 • Screening up to Week 8-10
The overall treatment-emergent adverse event (TEAEs), serious adverse events, and adverse events leading to discontinuation are based on 244 participants who were randomized and received at least 1 dose of study drug.
|
|
Cardiac disorders
Sinus arrest
|
0.00%
0/123 • Screening up to Week 8-10
The overall treatment-emergent adverse event (TEAEs), serious adverse events, and adverse events leading to discontinuation are based on 244 participants who were randomized and received at least 1 dose of study drug.
|
0.83%
1/121 • Screening up to Week 8-10
The overall treatment-emergent adverse event (TEAEs), serious adverse events, and adverse events leading to discontinuation are based on 244 participants who were randomized and received at least 1 dose of study drug.
|
|
Cardiac disorders
Tachyarrhythmia
|
0.00%
0/123 • Screening up to Week 8-10
The overall treatment-emergent adverse event (TEAEs), serious adverse events, and adverse events leading to discontinuation are based on 244 participants who were randomized and received at least 1 dose of study drug.
|
0.83%
1/121 • Screening up to Week 8-10
The overall treatment-emergent adverse event (TEAEs), serious adverse events, and adverse events leading to discontinuation are based on 244 participants who were randomized and received at least 1 dose of study drug.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.81%
1/123 • Screening up to Week 8-10
The overall treatment-emergent adverse event (TEAEs), serious adverse events, and adverse events leading to discontinuation are based on 244 participants who were randomized and received at least 1 dose of study drug.
|
0.83%
1/121 • Screening up to Week 8-10
The overall treatment-emergent adverse event (TEAEs), serious adverse events, and adverse events leading to discontinuation are based on 244 participants who were randomized and received at least 1 dose of study drug.
|
|
General disorders
Chest pain
|
0.00%
0/123 • Screening up to Week 8-10
The overall treatment-emergent adverse event (TEAEs), serious adverse events, and adverse events leading to discontinuation are based on 244 participants who were randomized and received at least 1 dose of study drug.
|
0.83%
1/121 • Screening up to Week 8-10
The overall treatment-emergent adverse event (TEAEs), serious adverse events, and adverse events leading to discontinuation are based on 244 participants who were randomized and received at least 1 dose of study drug.
|
|
General disorders
Death
|
0.00%
0/123 • Screening up to Week 8-10
The overall treatment-emergent adverse event (TEAEs), serious adverse events, and adverse events leading to discontinuation are based on 244 participants who were randomized and received at least 1 dose of study drug.
|
0.83%
1/121 • Screening up to Week 8-10
The overall treatment-emergent adverse event (TEAEs), serious adverse events, and adverse events leading to discontinuation are based on 244 participants who were randomized and received at least 1 dose of study drug.
|
|
General disorders
Puncture site haemorrhage
|
0.00%
0/123 • Screening up to Week 8-10
The overall treatment-emergent adverse event (TEAEs), serious adverse events, and adverse events leading to discontinuation are based on 244 participants who were randomized and received at least 1 dose of study drug.
|
0.83%
1/121 • Screening up to Week 8-10
The overall treatment-emergent adverse event (TEAEs), serious adverse events, and adverse events leading to discontinuation are based on 244 participants who were randomized and received at least 1 dose of study drug.
|
|
General disorders
Pyrexia
|
1.6%
2/123 • Screening up to Week 8-10
The overall treatment-emergent adverse event (TEAEs), serious adverse events, and adverse events leading to discontinuation are based on 244 participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/121 • Screening up to Week 8-10
The overall treatment-emergent adverse event (TEAEs), serious adverse events, and adverse events leading to discontinuation are based on 244 participants who were randomized and received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.81%
1/123 • Screening up to Week 8-10
The overall treatment-emergent adverse event (TEAEs), serious adverse events, and adverse events leading to discontinuation are based on 244 participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/121 • Screening up to Week 8-10
The overall treatment-emergent adverse event (TEAEs), serious adverse events, and adverse events leading to discontinuation are based on 244 participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/123 • Screening up to Week 8-10
The overall treatment-emergent adverse event (TEAEs), serious adverse events, and adverse events leading to discontinuation are based on 244 participants who were randomized and received at least 1 dose of study drug.
|
0.83%
1/121 • Screening up to Week 8-10
The overall treatment-emergent adverse event (TEAEs), serious adverse events, and adverse events leading to discontinuation are based on 244 participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Pharyngitis
|
0.81%
1/123 • Screening up to Week 8-10
The overall treatment-emergent adverse event (TEAEs), serious adverse events, and adverse events leading to discontinuation are based on 244 participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/121 • Screening up to Week 8-10
The overall treatment-emergent adverse event (TEAEs), serious adverse events, and adverse events leading to discontinuation are based on 244 participants who were randomized and received at least 1 dose of study drug.
|
|
Infections and infestations
Respiratory tract infection
|
0.81%
1/123 • Screening up to Week 8-10
The overall treatment-emergent adverse event (TEAEs), serious adverse events, and adverse events leading to discontinuation are based on 244 participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/121 • Screening up to Week 8-10
The overall treatment-emergent adverse event (TEAEs), serious adverse events, and adverse events leading to discontinuation are based on 244 participants who were randomized and received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/123 • Screening up to Week 8-10
The overall treatment-emergent adverse event (TEAEs), serious adverse events, and adverse events leading to discontinuation are based on 244 participants who were randomized and received at least 1 dose of study drug.
|
0.83%
1/121 • Screening up to Week 8-10
The overall treatment-emergent adverse event (TEAEs), serious adverse events, and adverse events leading to discontinuation are based on 244 participants who were randomized and received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.81%
1/123 • Screening up to Week 8-10
The overall treatment-emergent adverse event (TEAEs), serious adverse events, and adverse events leading to discontinuation are based on 244 participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/121 • Screening up to Week 8-10
The overall treatment-emergent adverse event (TEAEs), serious adverse events, and adverse events leading to discontinuation are based on 244 participants who were randomized and received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/123 • Screening up to Week 8-10
The overall treatment-emergent adverse event (TEAEs), serious adverse events, and adverse events leading to discontinuation are based on 244 participants who were randomized and received at least 1 dose of study drug.
|
0.83%
1/121 • Screening up to Week 8-10
The overall treatment-emergent adverse event (TEAEs), serious adverse events, and adverse events leading to discontinuation are based on 244 participants who were randomized and received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
1.6%
2/123 • Screening up to Week 8-10
The overall treatment-emergent adverse event (TEAEs), serious adverse events, and adverse events leading to discontinuation are based on 244 participants who were randomized and received at least 1 dose of study drug.
|
1.7%
2/121 • Screening up to Week 8-10
The overall treatment-emergent adverse event (TEAEs), serious adverse events, and adverse events leading to discontinuation are based on 244 participants who were randomized and received at least 1 dose of study drug.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/123 • Screening up to Week 8-10
The overall treatment-emergent adverse event (TEAEs), serious adverse events, and adverse events leading to discontinuation are based on 244 participants who were randomized and received at least 1 dose of study drug.
|
0.83%
1/121 • Screening up to Week 8-10
The overall treatment-emergent adverse event (TEAEs), serious adverse events, and adverse events leading to discontinuation are based on 244 participants who were randomized and received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/123 • Screening up to Week 8-10
The overall treatment-emergent adverse event (TEAEs), serious adverse events, and adverse events leading to discontinuation are based on 244 participants who were randomized and received at least 1 dose of study drug.
|
0.83%
1/121 • Screening up to Week 8-10
The overall treatment-emergent adverse event (TEAEs), serious adverse events, and adverse events leading to discontinuation are based on 244 participants who were randomized and received at least 1 dose of study drug.
|
|
Nervous system disorders
Atonic seizures
|
0.00%
0/123 • Screening up to Week 8-10
The overall treatment-emergent adverse event (TEAEs), serious adverse events, and adverse events leading to discontinuation are based on 244 participants who were randomized and received at least 1 dose of study drug.
|
0.83%
1/121 • Screening up to Week 8-10
The overall treatment-emergent adverse event (TEAEs), serious adverse events, and adverse events leading to discontinuation are based on 244 participants who were randomized and received at least 1 dose of study drug.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/123 • Screening up to Week 8-10
The overall treatment-emergent adverse event (TEAEs), serious adverse events, and adverse events leading to discontinuation are based on 244 participants who were randomized and received at least 1 dose of study drug.
|
0.83%
1/121 • Screening up to Week 8-10
The overall treatment-emergent adverse event (TEAEs), serious adverse events, and adverse events leading to discontinuation are based on 244 participants who were randomized and received at least 1 dose of study drug.
|
|
Nervous system disorders
Loss of consciousness
|
0.81%
1/123 • Screening up to Week 8-10
The overall treatment-emergent adverse event (TEAEs), serious adverse events, and adverse events leading to discontinuation are based on 244 participants who were randomized and received at least 1 dose of study drug.
|
0.00%
0/121 • Screening up to Week 8-10
The overall treatment-emergent adverse event (TEAEs), serious adverse events, and adverse events leading to discontinuation are based on 244 participants who were randomized and received at least 1 dose of study drug.
|
|
Nervous system disorders
Migraine
|
0.00%
0/123 • Screening up to Week 8-10
The overall treatment-emergent adverse event (TEAEs), serious adverse events, and adverse events leading to discontinuation are based on 244 participants who were randomized and received at least 1 dose of study drug.
|
0.83%
1/121 • Screening up to Week 8-10
The overall treatment-emergent adverse event (TEAEs), serious adverse events, and adverse events leading to discontinuation are based on 244 participants who were randomized and received at least 1 dose of study drug.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/123 • Screening up to Week 8-10
The overall treatment-emergent adverse event (TEAEs), serious adverse events, and adverse events leading to discontinuation are based on 244 participants who were randomized and received at least 1 dose of study drug.
|
0.83%
1/121 • Screening up to Week 8-10
The overall treatment-emergent adverse event (TEAEs), serious adverse events, and adverse events leading to discontinuation are based on 244 participants who were randomized and received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/123 • Screening up to Week 8-10
The overall treatment-emergent adverse event (TEAEs), serious adverse events, and adverse events leading to discontinuation are based on 244 participants who were randomized and received at least 1 dose of study drug.
|
0.83%
1/121 • Screening up to Week 8-10
The overall treatment-emergent adverse event (TEAEs), serious adverse events, and adverse events leading to discontinuation are based on 244 participants who were randomized and received at least 1 dose of study drug.
|
|
Vascular disorders
Arteriovenous fistula
|
0.00%
0/123 • Screening up to Week 8-10
The overall treatment-emergent adverse event (TEAEs), serious adverse events, and adverse events leading to discontinuation are based on 244 participants who were randomized and received at least 1 dose of study drug.
|
0.83%
1/121 • Screening up to Week 8-10
The overall treatment-emergent adverse event (TEAEs), serious adverse events, and adverse events leading to discontinuation are based on 244 participants who were randomized and received at least 1 dose of study drug.
|
Other adverse events
| Measure |
Rivaroxaban
n=123 participants at risk
Participants were received Rivaroxaban 20 milligram (mg) orally once-daily administered preferably with the evening meal for 8-10 weeks.
|
Vitamin K Antagonist
n=121 participants at risk
Participants were received dose-adjusted vitamin K antagonist (VKA) to achieve a recommended International Normalized Ratio (INR) of 2.0 to 3.0 for 8-10 weeks.
|
|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
8.1%
10/123 • Screening up to Week 8-10
The overall treatment-emergent adverse event (TEAEs), serious adverse events, and adverse events leading to discontinuation are based on 244 participants who were randomized and received at least 1 dose of study drug.
|
8.3%
10/121 • Screening up to Week 8-10
The overall treatment-emergent adverse event (TEAEs), serious adverse events, and adverse events leading to discontinuation are based on 244 participants who were randomized and received at least 1 dose of study drug.
|
|
General disorders
Fatigue
|
6.5%
8/123 • Screening up to Week 8-10
The overall treatment-emergent adverse event (TEAEs), serious adverse events, and adverse events leading to discontinuation are based on 244 participants who were randomized and received at least 1 dose of study drug.
|
1.7%
2/121 • Screening up to Week 8-10
The overall treatment-emergent adverse event (TEAEs), serious adverse events, and adverse events leading to discontinuation are based on 244 participants who were randomized and received at least 1 dose of study drug.
|
|
Vascular disorders
Haematoma
|
7.3%
9/123 • Screening up to Week 8-10
The overall treatment-emergent adverse event (TEAEs), serious adverse events, and adverse events leading to discontinuation are based on 244 participants who were randomized and received at least 1 dose of study drug.
|
7.4%
9/121 • Screening up to Week 8-10
The overall treatment-emergent adverse event (TEAEs), serious adverse events, and adverse events leading to discontinuation are based on 244 participants who were randomized and received at least 1 dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
- Publication restrictions are in place
Restriction type: OTHER