A Phase 3 interventional study of Rivaroxaban (Xarelto, BAY59-7939) and Vitamin K antagonist (VKA) in Atrial Fibrillation, sponsored by Bayer. Completed at 178 sites in 17 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-04-30.
Sponsored by Bayer · Phase 3, Interventional, and Prevention
A study for patients with abnormal heart rhythm (atrial fibrillation) who need to undergo cardioversion (procedure to restore normal heart rhythm). The study will compare patients assigned randomly (like flipping a coin) to either Rivaroxaban or vitamin K antagonist (VKA). The study will measure common medical outcomes for this type of patient such as bleeding and stroke.
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
This study's enrollment of 1,504 is above the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.
Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
A Direct Cardioversion Strategy can be performed only if sufficient anticoagulation is proven during the last 21 days prior to randomization and/or a transesophageal echocardiogram (TEE) is planned before cardioversion. Rivaroxaban will be given for 1-5 days before planned direct cardioversion. The run-in of 1-5 days is needed due to potential pretreatment with VKA. Treatment with rivaroxaban will be continued for 42 days after the cardioversion. A Delayed Cardioversion Strategy will be chosen if sufficient anticoagulation is not proven during the last 21 days prior to randomization and no TEE is planned. Rivaroxaban will be given for at least 21 (+4) days before the planned cardioversion, to a maximum of 56 (+4) days prior to planned cardioversion.
Drug: Rivaroxaban (Xarelto, BAY59-7939)
A Direct Cardioversion Strategy can be performed only if sufficient anticoagulation is proven during the last 21 days prior to randomization and/or a transesophageal echocardiogram (TEE) is planned before cardioversion. VKA will be given for 1-5 days before planned direct cardioversion. The run-in of 1-5 days is needed due to potential pretreatment with VKA. Treatment with VKA will be continued for 42 days after the cardioversion. A Delayed Cardioversion Strategy will be chosen if sufficient anticoagulation is not proven during the last 21 days prior to randomization and no TEE is planned. VKA will be given for at least 21 (+4) days before the planned cardioversion, to a maximum of 56 (+4) days prior to planned cardioversion.
Drug: Vitamin K antagonist (VKA)
Rivaroxaban 20 mg orally once daily; subjects with moderate renal impairment (ie, CrCl of 30 to 49 mL/min, inclusive) will receive the adjusted dose of 15 mg orally once daily in the study
VKA orally once daily titrated to a target international normalized ratio (INR) of 2.5 (range 2.0-3.0, inclusive); the VKA type (eg, warfarin, acenocoumarol, phenprocoumon, fluindione, etc) will be assigned by the investigator according to local treatment standards
Number of Participants With Composite of the Following Events, Adjudicated Centrally: Stroke, Transient Ischemic Attack, Non-central Nervous System Systemic Embolism, Myocardial Infarction and Cardiovascular Death
Stroke, TIA, Non-CNS Embolism, MI and cardiovascular death were adjudicated and confirmed by Clinical Endpoints Committee (CEC). Stroke included hemorrhagic and ischemic infarction. TIA including information if with or without matching lesion. Non CNS systemic embolism included emboli in peripheral arterial of the upper and lower extremities, ocular and retinal (pulmonary embolism and MI were excluded from the category). MI was assessed based on either cardiac biomarkers, new abnormal Q waves appeared on electrocardiogram for \>= 2 leads, or autopsy confirmation. Cardiovascular death included death in subjects with non-valvular atrial fibrillation (AF). Number of subjects with composite events were reported.
Time frame: From randomization to the date of last dose of study drug +2 days for subjects who completed planned treatment or the earlier date [last planned dose, follow-up visit at the end of 30-day follow-up period] for subjects who prematurely stopped treatment
Number of Participants With Major Bleedings as Per Central Adjudication
Bleeding events were adjudicated and confirmed by CEC blinded to treatment. The CEC categorized the bleeding events as major or non-major. The bleeding events were defined per the International Society on Thrombosis and Hemostasis (ISTH) criteria. Major bleeding was clinically overt bleeding associated with a fall in hemoglobin of 2 gram per deciliter (g/dL) or higher, leading to a transfusion of 2 or more units of packed red blood cells or whole blood, occurring in a critical site or contributing to death. Number of subjects with confirmed adjudicated bleeding events occurring in greater than (\>)1 total subjects were reported.
Time frame: From randomization up to the date of the last dose of study drug + 2 days
Number of Participants With Composite of Strokes and Non-central Nervous System Systemic Embolisms
Stroke and Non-CNS Embolism were adjudicated and confirmed by CEC. Stroke included hemorrhagic and ischemic infarction. Non CNS systemic embolism included emboli in peripheral arterial of the upper and lower extremities, ocular and retinal (pulmonary embolism and MI were excluded from the category). Number of subjects with composite events were reported.
Time frame: From randomization to the date of last dose of study drug +2 days for subjects who completed planned treatment or the earlier date [last planned dose, follow-up visit at the end of 30-day follow-up period] for subjects who prematurely stopped treatment
Number of Participants With Composite of Strokes, Transient Ischemic Attacks, Non-central Nervous System Systemic Embolisms, Myocardial Infarctions and All-cause Mortality
Stroke, TIA, Non- CNS systemic embolism, MI and all-cause mortality were adjudicated and confirmed by CEC. Stroke included hemorrhagic and ischemic infarction. TIA including information if with or without matching lesion. Non CNS systemic embolism included emboli in peripheral arterial of the upper and lower extremities, ocular and retinal (pulmonary embolism and MI were excluded from the category). MI was assessed based on either cardiac biomarkers, new abnormal Q waves appeared on electrocardiogram for \>= 2 leads, or autopsy confirmation. All-cause mortality included vascular death and non-vascular death. Number of subjects with composite events were reported.
Time frame: From randomization to the date of last dose of study drug +2 days for subjects who completed planned treatment or the earlier date [last planned dose, follow-up visit at the end of 30-day follow-up period] for subjects who prematurely stopped treatment
Number of Participants With Strokes
All events were adjudicated and confirmed by a CEC blinded to treatment. Stroke included hemorrhagic (Stroke with local collections of intraparenchymal blood. Subarachnoid hemorrhage, subdural hemorrhage, and epidural hemorrhage were excluded), ischemic infarction (Stroke without focal collection of intracranial blood) and unknown (No imaging data and anatomic findings were available). Number of subjects with strokes were reported.
Time frame: From randomization to the date of last dose of study drug +2 days for subjects who completed planned treatment or the earlier date [last planned dose, follow-up visit at the end of 30-day follow-up period] for subjects who prematurely stopped treatment
Number of Participants With Transient Ischemic Attacks
All events were adjudicated and confirmed by a CEC blinded to treatment. Number of subjects with TIA were reported.
Time frame: From randomization to the date of last dose of study drug +2 days for subjects who completed planned treatment or the earlier date [last planned dose, follow-up visit at the end of 30-day follow-up period] for subjects who prematurely stopped treatment
Number of Participants With Non-central Nervous System Systemic Embolisms
All events were adjudicated and confirmed by a CEC blinded to treatment. Non CNS systemic embolism included emboli in peripheral arterial of the upper and lower extremities, ocular and retinal (pulmonary embolism and MI were excluded from the category). Number of subjects with non-CNS embolism were reported.
Time frame: From randomization to the date of last dose of study drug +2 days for subjects who completed planned treatment or the earlier date [last planned dose, follow-up visit at the end of 30-day follow-up period] for subjects who prematurely stopped treatment
Number of Participants With Myocardial Infarctions
All events were adjudicated and confirmed by a CEC blinded to treatment. MI was assessed based onmeither cardiac biomarkers, new abnormal Q waves appeared on electrocardiogram for \>= 2 leads, or autopsy confirmation. Number of subjects with MI were reported.
Time frame: From randomization to the date of last dose of study drug +2 days for subjects who completed planned treatment or the earlier date [last planned dose, follow-up visit at the end of 30-day follow-up period] for subjects who prematurely stopped treatment
Number of Participants With Cardiovascular Deaths
All events were adjudicated and confirmed by a CEC blinded to treatment. Any death that was not clearly non-vascular (e.g., deaths due to spontaneous bleeding, myocardial infarction, stroke, cardiac failure, and arrhythmia). Number of subjects with cardiovascular deaths were reported.
Time frame: From randomization to the date of last dose of study drug +2 days for subjects who completed planned treatment or the earlier date [last planned dose, follow-up visit at the end of 30-day follow-up period] for subjects who prematurely stopped treatment
Number of Participants With All-cause Mortality
All events were adjudicated and confirmed by a CEC blinded to treatment. All-cause mortality included vascular death and non-vascular death. Number of subjects with all-cause mortality were reported.
Time frame: From randomization to the date of last dose of study drug +2 days for subjects who completed planned treatment or the earlier date [last planned dose, follow-up visit at the end of 30-day follow-up period] for subjects who prematurely stopped treatment
Number of Participants With Composite of Major and Non-major Bleeding Events
All events were adjudicated and confirmed by a CEC blinded to treatment. The CEC categorized the bleeding events as major or non-major. The bleeding events were defined per the ISTH criteria. Clinically relevant bleeding included major bleeding (overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of 2 or more units of packed red blood cells or whole blood, occurring in a critical site or contributing to death) and non-major bleeding associated with medical intervention, unscheduled physician contact, (temporary) cessation of study treatment, discomfort for the participants such as pain, or impairment of activities of daily life. Number of subjects with clinically relevant major and non-major bleeding events were reported.
Time frame: From randomization up to the date of the last dose of study drug + 2 days
The study was conducted at 141 centers (involving 144 investigators) in Europe, South Africa, North America, and Asia Pacific.
| Milestone | Rivaroxaban (Xarelto, BAY59-7939) | Vitamin K Antagonist (VKA) |
|---|---|---|
| Started | 1002 | 502 |
| Subjects received treatment | 988 | 499 |
| Completed | 846 | 400 |
| Not completed | 156 | 102 |
| Withdrew: Death | 4 | 1 |
| Withdrew: Efficacy outcome reached | 0 | 1 |
| Withdrew: Physician decision | 3 | 1 |
| Withdrew: Adverse event | 60 | 22 |
| Withdrew: Non-compliance with study drug | 3 | 0 |
| Withdrew: Lost to follow-up | 1 | 1 |
| Withdrew: Withdrawal by subject | 19 | 16 |
| Withdrew: Switching to other therapy | 5 | 2 |
| Withdrew: Logistical difficulties | 5 | 8 |
| Withdrew: Treatment failure | 0 | 14 |
| Withdrew: Protocol violation | 56 | 36 |
| Milestone | Rivaroxaban (Xarelto, BAY59-7939) | Vitamin K Antagonist (VKA) |
|---|---|---|
| Started | 982 | 487 |
| Completed | 924 | 446 |
| Not completed | 58 | 41 |
| Withdrew: Death | 3 | 2 |
| Withdrew: Non-compliance with study drug | 0 | 1 |
| Withdrew: Protocol violation | 39 | 22 |
| Withdrew: Logistical difficulties | 1 | 3 |
| Withdrew: Withdrawal by subject | 7 | 8 |
| Withdrew: Lost to follow-up | 8 | 5 |
Stroke, TIA, Non-CNS Embolism, MI and cardiovascular death were adjudicated and confirmed by Clinical Endpoints Committee (CEC). Stroke included hemorrhagic and ischemic infarction. TIA including information if with or without matching lesion. Non CNS systemic embolism included emboli in peripheral arterial of the upper and lower extremities, ocular and retinal (pulmonary embolism and MI were excluded from the category). MI was assessed based on either cardiac biomarkers, new abnormal Q waves appeared on electrocardiogram for \>= 2 leads, or autopsy confirmation. Cardiovascular death included death in subjects with non-valvular atrial fibrillation (AF). Number of subjects with composite events were reported.
| Participants | Rivaroxaban (Xarelto, BAY59-7939) | Vitamin K Antagonist (VKA) |
|---|---|---|
| Number of Participants With Composite of the Following Events, Adjudicated Centrally: Stroke, Transient Ischemic Attack, Non-central Nervous System Systemic Embolism, Myocardial Infarction and Cardiovascular Death | 5 | 5 |
Bleeding events were adjudicated and confirmed by CEC blinded to treatment. The CEC categorized the bleeding events as major or non-major. The bleeding events were defined per the International Society on Thrombosis and Hemostasis (ISTH) criteria. Major bleeding was clinically overt bleeding associated with a fall in hemoglobin of 2 gram per deciliter (g/dL) or higher, leading to a transfusion of 2 or more units of packed red blood cells or whole blood, occurring in a critical site or contributing to death. Number of subjects with confirmed adjudicated bleeding events occurring in greater than (\>)1 total subjects were reported.
| Participants | Rivaroxaban (Xarelto, BAY59-7939) | Vitamin K Antagonist (VKA) |
|---|---|---|
| Number of Participants With Major Bleedings as Per Central Adjudication | 6 | 4 |
Stroke and Non-CNS Embolism were adjudicated and confirmed by CEC. Stroke included hemorrhagic and ischemic infarction. Non CNS systemic embolism included emboli in peripheral arterial of the upper and lower extremities, ocular and retinal (pulmonary embolism and MI were excluded from the category). Number of subjects with composite events were reported.
| Participants | Rivaroxaban (Xarelto, BAY59-7939) | Vitamin K Antagonist (VKA) |
|---|---|---|
| Number of Participants With Composite of Strokes and Non-central Nervous System Systemic Embolisms | 2 | 3 |
Stroke, TIA, Non- CNS systemic embolism, MI and all-cause mortality were adjudicated and confirmed by CEC. Stroke included hemorrhagic and ischemic infarction. TIA including information if with or without matching lesion. Non CNS systemic embolism included emboli in peripheral arterial of the upper and lower extremities, ocular and retinal (pulmonary embolism and MI were excluded from the category). MI was assessed based on either cardiac biomarkers, new abnormal Q waves appeared on electrocardiogram for \>= 2 leads, or autopsy confirmation. All-cause mortality included vascular death and non-vascular death. Number of subjects with composite events were reported.
| Participants | Rivaroxaban (Xarelto, BAY59-7939) | Vitamin K Antagonist (VKA) |
|---|---|---|
| Number of Participants With Composite of Strokes, Transient Ischemic Attacks, Non-central Nervous System Systemic Embolisms, Myocardial Infarctions and All-cause Mortality | 6 | 6 |
All events were adjudicated and confirmed by a CEC blinded to treatment. Stroke included hemorrhagic (Stroke with local collections of intraparenchymal blood. Subarachnoid hemorrhage, subdural hemorrhage, and epidural hemorrhage were excluded), ischemic infarction (Stroke without focal collection of intracranial blood) and unknown (No imaging data and anatomic findings were available). Number of subjects with strokes were reported.
| Participants | Rivaroxaban (Xarelto, BAY59-7939) | Vitamin K Antagonist (VKA) |
|---|---|---|
| Number of Participants With Strokes | 2 | 2 |
All events were adjudicated and confirmed by a CEC blinded to treatment. Number of subjects with TIA were reported.
| Participants | Rivaroxaban (Xarelto, BAY59-7939) | Vitamin K Antagonist (VKA) |
|---|---|---|
| Number of Participants With Transient Ischemic Attacks | 0 | 0 |
All events were adjudicated and confirmed by a CEC blinded to treatment. Non CNS systemic embolism included emboli in peripheral arterial of the upper and lower extremities, ocular and retinal (pulmonary embolism and MI were excluded from the category). Number of subjects with non-CNS embolism were reported.
| Participants | Rivaroxaban (Xarelto, BAY59-7939) | Vitamin K Antagonist (VKA) |
|---|---|---|
| Number of Participants With Non-central Nervous System Systemic Embolisms | 0 | 1 |
All events were adjudicated and confirmed by a CEC blinded to treatment. MI was assessed based onmeither cardiac biomarkers, new abnormal Q waves appeared on electrocardiogram for \>= 2 leads, or autopsy confirmation. Number of subjects with MI were reported.
| Participants | Rivaroxaban (Xarelto, BAY59-7939) | Vitamin K Antagonist (VKA) |
|---|---|---|
| Number of Participants With Myocardial Infarctions | 1 | 1 |
All events were adjudicated and confirmed by a CEC blinded to treatment. Any death that was not clearly non-vascular (e.g., deaths due to spontaneous bleeding, myocardial infarction, stroke, cardiac failure, and arrhythmia). Number of subjects with cardiovascular deaths were reported.
| Participants | Rivaroxaban (Xarelto, BAY59-7939) | Vitamin K Antagonist (VKA) |
|---|---|---|
| Number of Participants With Cardiovascular Deaths | 4 | 2 |
All events were adjudicated and confirmed by a CEC blinded to treatment. All-cause mortality included vascular death and non-vascular death. Number of subjects with all-cause mortality were reported.
| Participants | Rivaroxaban (Xarelto, BAY59-7939) | Vitamin K Antagonist (VKA) |
|---|---|---|
| Number of Participants With All-cause Mortality | 5 | 3 |
All events were adjudicated and confirmed by a CEC blinded to treatment. The CEC categorized the bleeding events as major or non-major. The bleeding events were defined per the ISTH criteria. Clinically relevant bleeding included major bleeding (overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of 2 or more units of packed red blood cells or whole blood, occurring in a critical site or contributing to death) and non-major bleeding associated with medical intervention, unscheduled physician contact, (temporary) cessation of study treatment, discomfort for the participants such as pain, or impairment of activities of daily life. Number of subjects with clinically relevant major and non-major bleeding events were reported.
| Participants | Rivaroxaban (Xarelto, BAY59-7939) | Vitamin K Antagonist (VKA) |
|---|---|---|
| Number of Participants With Composite of Major and Non-major Bleeding Events | 33 | 14 |
Collected over From first administration of study drug to date of last study drug + 2 days. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Rivaroxaban (Xarelto; BAY59-7939) | — | 93/988 (9.4%) | 272/988 (27.5%) |
| Vitamin K Antagonist | — | 38/499 (7.6%) | 126/499 (25.3%) |
| Event | Rivaroxaban (Xarelto; BAY59-7939) | Vitamin K Antagonist |
|---|---|---|
| Cardiac failure congestiveCardiac disorders | 10/988 | 2/499 |
| Atrial fibrillationCardiac disorders | 8/988 | 4/499 |
| Cardiac failureCardiac disorders | 8/988 | 2/499 |
| Atrial thrombosisCardiac disorders | 4/988 | 3/499 |
| BradycardiaCardiac disorders | 3/988 | 3/499 |
| PneumoniaInfections and infestations | 2/988 | 3/499 |
| Chest painGeneral disorders | 5/988 | 0/499 |
| Atrial flutterCardiac disorders | 4/988 | 1/499 |
| Abdominal painGastrointestinal disorders | 4/988 | 0/499 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 4/988 | 1/499 |
| Event | Rivaroxaban (Xarelto; BAY59-7939) | Vitamin K Antagonist |
|---|---|---|
| Atrioventricular block first degreeCardiac disorders | 40/988 | 25/499 |
| BradycardiaCardiac disorders | 30/988 | 13/499 |
| EpistaxisRespiratory, thoracic and mediastinal disorders | 30/988 | 9/499 |
| Sinus bradycardiaCardiac disorders | 25/988 | 12/499 |
| DizzinessNervous system disorders | 25/988 | 9/499 |
| HeadacheNervous system disorders | 25/988 | 7/499 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 16/988 | 12/499 |
| HypertensionVascular disorders | 22/988 | 4/499 |
| Oedema peripheralGeneral disorders | 20/988 | 5/499 |
| DiarrhoeaGastrointestinal disorders | 18/988 | 3/499 |
| Age, Continuous(years) | Rivaroxaban (Xarelto, BAY59-7939) | Vitamin K Antagonist (VKA) | Total |
|---|---|---|---|
| Mean | 64.9 ± 10.6 | 64.7 ± 10.5 | 64.9 ± 10.5 |
| Sex: Female, Male(Participants) | Rivaroxaban (Xarelto, BAY59-7939) | Vitamin K Antagonist (VKA) | Total |
|---|---|---|---|
| Female | 275 | 135 | 410 |
| Male | 727 | 367 | 1094 |
| CHADS 2 score(units on scale) | Rivaroxaban (Xarelto, BAY59-7939) | Vitamin K Antagonist (VKA) | Total |
|---|---|---|---|
| Mean | 1.3 ± 1.1 | 1.4 ± 1.1 | 1.4 ± 1.1 |
| CHA 2 DS 2 VASc score(units on scale) | Rivaroxaban (Xarelto, BAY59-7939) | Vitamin K Antagonist (VKA) | Total |
|---|---|---|---|
| Mean | 2.3 ± 1.6 | 2.3 ± 1.6 | 2.3 ± 1.6 |
Showing the first 100 of 178 sites across 17 countries.
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