Trial · NCT01674647
Explore the Efficacy and Safety of Once-daily Oral Rivaroxaban for the Prevention of Cardiovascular Events in Subjects With Nonvalvular Atrial Fibrillation Scheduled for Cardioversion
NCT01674647, Phase 3, Completed, Bayer; results first posted 2015-02-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Explore the Efficacy and Safety of Once-daily Oral Rivaroxaban for the Prevention of Cardiovascular Events in Subjects With Nonvalvular Atrial Fibrillation Scheduled for Cardioversion. Trials, record NCT01674647. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01674647
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Explore the Efficacy and Safety of Once-daily Oral Rivaroxaban for the Prevention of Cardiovascular Events in Subjects With Nonvalvular Atrial Fibrillation Scheduled for Cardioversion
- NCT number
- NCT01674647
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,504 participants, actual
- Lead sponsor
- Bayer
- Conditions
- Atrial Fibrillation
- Interventions
- Rivaroxaban (Xarelto, BAY59-7939), Vitamin K antagonist (VKA)
- First posted
- 2012-08-29
- Last updated
- 2015-04-30
- Other registries' IDs
- eudract:2011-002234-39
- Results first posted
- 2015-02-03
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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 | 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. |
| Primary | Number of Participants With Major Bleedings as Per Central Adjudication | From randomization up to the date of the last dose of study drug + 2 days | 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. |
| Secondary | Number of Participants With Composite of Strokes and Non-central Nervous System Systemic Embolisms | 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 | 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. |
| Secondary | Number of Participants With Composite of Strokes, Transient Ischemic Attacks, Non-central Nervous System Systemic Embolisms, Myocardial Infarctions and All-cause Mortality | 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 | 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. |
| Secondary | Number of Participants With Strokes | 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 | 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. |
| Secondary | Number of Participants With Transient Ischemic Attacks | 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 | All events were adjudicated and confirmed by a CEC blinded to treatment. Number of subjects with TIA were reported. |
| Secondary | Number of Participants With Non-central Nervous System Systemic Embolisms | 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 | 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. |
| Secondary | Number of Participants With Myocardial Infarctions | 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 | 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. |
| Secondary | Number of Participants With Cardiovascular Deaths | 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 | 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. |
| Secondary | Number of Participants With All-cause Mortality | 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 | 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. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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 | 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 | The primary population for the efficacy analysis was the modified intention-to-treat (mITT) population. mITT population included all the randomized subjects in whom a left atrial/left atrial appendage (LA/LAA) thrombus was not diagnosed during a transesophageal echocardiogram (TEE) performed before the first planned cardioversion in the study. | Participants | NUMBER |
| PRIMARY | Number of Participants With Major Bleedings as Per Central Adjudication | From randomization up to the date of the last dose of study drug + 2 days | The safety profile was analyzed using the safety analysis set (SAF) population. SAF population included all randomized subjects who received at least 1 dose of study medication. | Participants | NUMBER |
| SECONDARY | Number of Participants With Composite of Strokes and Non-central Nervous System Systemic Embolisms | 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 | The primary population for the efficacy analysis was the mITT population. mITT population included all the randomized subjects in whom a LA/LAA thrombus was not diagnosed during a TEE performed before the first planned cardioversion in the study. | Participants | NUMBER |
| SECONDARY | Number of Participants With Composite of Strokes, Transient Ischemic Attacks, Non-central Nervous System Systemic Embolisms, Myocardial Infarctions and All-cause Mortality | 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 | The primary population for the efficacy analysis was the mITT population. mITT population included all the randomized subjects in whom a LA/LAA thrombus was not diagnosed during a TEE performed before the first planned cardioversion in the study. | Participants | NUMBER |
| SECONDARY | Number of Participants With Strokes | 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 | The primary population for the efficacy analysis was the mITT population. mITT population included all the randomized subjects in whom a LA/LAA thrombus was not diagnosed during a TEE performed before the first planned cardioversion in the study. | Participants | NUMBER |
| SECONDARY | Number of Participants With Transient Ischemic Attacks | 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 | The primary population for the efficacy analysis was the mITT population. mITT population included all the randomized subjects in whom a LA/LAA thrombus was not diagnosed during a TEE performed before the first planned cardioversion in the study. | Participants | NUMBER |
| SECONDARY | Number of Participants With Non-central Nervous System Systemic Embolisms | 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 | The primary population for the efficacy analysis was the mITT population. mITT population included all the randomized subjects in whom a LA/LAA thrombus was not diagnosed during a TEE performed before the first planned cardioversion in the study. | Participants | NUMBER |
| SECONDARY | Number of Participants With Myocardial Infarctions | 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 | The primary population for the efficacy analysis was the mITT population. mITT population included all the randomized subjects in whom a LA/LAA thrombus was not diagnosed during a TEE performed before the first planned cardioversion in the study. | Participants | NUMBER |
| SECONDARY | Number of Participants With Cardiovascular Deaths | 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 | The primary population for the efficacy analysis was the mITT population. mITT population included all the randomized subjects in whom a LA/LAA thrombus was not diagnosed during a TEE performed before the first planned cardioversion in the study. | Participants | NUMBER |
| SECONDARY | Number of Participants With All-cause Mortality | 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 | The primary population for the efficacy analysis was the mITT population. mITT population included all the randomized subjects in whom a LA/LAA thrombus was not diagnosed during a TEE performed before the first planned cardioversion in the study. | Participants | NUMBER |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group22
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
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 | Rivaroxaban (Xarelto, BAY59-7939) | 5 | Participants | ||
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 | Vitamin K Antagonist (VKA) | 5 | Participants | ||
| Number of Participants With Major Bleedings as Per Central Adjudication | Rivaroxaban (Xarelto, BAY59-7939) | 6 | Participants | ||
| Number of Participants With Major Bleedings as Per Central Adjudication | Vitamin K Antagonist (VKA) | 4 | Participants | ||
| Number of Participants With Composite of Strokes and Non-central Nervous System Systemic Embolisms | Rivaroxaban (Xarelto, BAY59-7939) | 2 | Participants | ||
| Number of Participants With Composite of Strokes and Non-central Nervous System Systemic Embolisms | Vitamin K Antagonist (VKA) | 3 | Participants | ||
| Number of Participants With Composite of Strokes, Transient Ischemic Attacks, Non-central Nervous System Systemic Embolisms, Myocardial Infarctions and All-cause Mortality | Rivaroxaban (Xarelto, BAY59-7939) | 6 | Participants | ||
| Number of Participants With Composite of Strokes, Transient Ischemic Attacks, Non-central Nervous System Systemic Embolisms, Myocardial Infarctions and All-cause Mortality | Vitamin K Antagonist (VKA) | 6 | Participants | ||
| Number of Participants With Strokes | Rivaroxaban (Xarelto, BAY59-7939) | 2 | Participants | ||
| Number of Participants With Strokes | Vitamin K Antagonist (VKA) | 2 | Participants |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 results by groupParticipant flow14
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Period | STARTED | Rivaroxaban (Xarelto, BAY59-7939) | 1,002 | |
| Treatment Period | STARTED | Vitamin K Antagonist (VKA) | 502 | |
| Treatment Period | Subjects Received Treatment | Rivaroxaban (Xarelto, BAY59-7939) | 988 | |
| Treatment Period | Subjects Received Treatment | Vitamin K Antagonist (VKA) | 499 | |
| Treatment Period | COMPLETED | Rivaroxaban (Xarelto, BAY59-7939) | 846 | |
| Treatment Period | COMPLETED | Vitamin K Antagonist (VKA) | 400 | |
| Treatment Period | NOT COMPLETED | Rivaroxaban (Xarelto, BAY59-7939) | 156 | |
| Treatment Period | NOT COMPLETED | Vitamin K Antagonist (VKA) | 102 | |
| 30-day Safety Follow-up Period | STARTED | Rivaroxaban (Xarelto, BAY59-7939) | 982 | |
| 30-day Safety Follow-up Period | STARTED | Vitamin K Antagonist (VKA) | 487 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 participant flowAdverse events226
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Atrial fibrillation | Cardiac disorders | Rivaroxaban (Xarelto; BAY59-7939) | 2 | 988 | |
| other | Atrial fibrillation | Cardiac disorders | Vitamin K Antagonist | 7 | 499 | |
| other | Atrial thrombosis | Cardiac disorders | Rivaroxaban (Xarelto; BAY59-7939) | 16 | 988 | |
| other | Atrial thrombosis | Cardiac disorders | Vitamin K Antagonist | 6 | 499 | |
| other | Atrioventricular block first degree | Cardiac disorders | Rivaroxaban (Xarelto; BAY59-7939) | 40 | 988 | |
| other | Atrioventricular block first degree | Cardiac disorders | Vitamin K Antagonist | 25 | 499 | |
| other | Bradycardia | Cardiac disorders | Rivaroxaban (Xarelto; BAY59-7939) | 30 | 988 | |
| other | Bradycardia | Cardiac disorders | Vitamin K Antagonist | 13 | 499 | |
| other | Sinus bradycardia | Cardiac disorders | Rivaroxaban (Xarelto; BAY59-7939) | 25 | 988 | |
| other | Sinus bradycardia | Cardiac disorders | Vitamin K Antagonist | 12 | 499 |
1 to 10 of 226Source ClinicalTrials.gov
See all 226 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Rivaroxaban (Xarelto; BAY59-7939) | ||
| Total, all-cause mortality | Vitamin K Antagonist | ||
| Total, other adverse events | Rivaroxaban (Xarelto; BAY59-7939) | 272 | 988 |
| Total, other adverse events | Vitamin K Antagonist | 126 | 499 |
| Total, serious adverse events | Rivaroxaban (Xarelto; BAY59-7939) | 93 | 988 |
| Total, serious adverse events | Vitamin K Antagonist | 38 | 499 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons12
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
Rivaroxaban (Xarelto, BAY59-7939) vs 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 | Trial comparisons |
Rivaroxaban (Xarelto, BAY59-7939) vs 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 | Trial comparisons |
| Rivaroxaban (Xarelto, BAY59-7939) vs Vitamin K Antagonist (VKA): Number of Participants With All-cause Mortality | Trial comparisons |
| Rivaroxaban (Xarelto, BAY59-7939) vs Vitamin K Antagonist (VKA): Number of Participants With Composite of Strokes and Non-central Nervous System Systemic Embolisms | Trial comparisons |
| Rivaroxaban (Xarelto, BAY59-7939) vs Vitamin K Antagonist (VKA): Number of Participants With Non-central Nervous System Systemic Embolisms | Trial comparisons |
| Rivaroxaban (Xarelto, BAY59-7939) vs Vitamin K Antagonist (VKA): Number of Participants With Strokes | Trial comparisons |
| Rivaroxaban (Xarelto, BAY59-7939) vs Vitamin K Antagonist (VKA): Number of Participants With Composite of Major and Non-major Bleeding Events | Trial comparisons |
| Rivaroxaban (Xarelto, BAY59-7939) vs Vitamin K Antagonist (VKA): Number of Participants With Transient Ischemic Attacks | Trial comparisons |
| Rivaroxaban (Xarelto, BAY59-7939) vs Vitamin K Antagonist (VKA): Number of Participants With Cardiovascular Deaths | Trial comparisons |
| Rivaroxaban (Xarelto, BAY59-7939) vs Vitamin K Antagonist (VKA): Number of Participants With Myocardial Infarctions | Trial comparisons |
1 to 10 of 12
See all 12 trial comparisonsTests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01674647
GET https://conductscience.org/api/trials/v1/NCT01674647/results?page=2