Trial · NCT01830543
A Study Exploring Two Strategies of Rivaroxaban (JNJ39039039; BAY-59-7939) and One of Oral Vitamin K Antagonist in Patients With Atrial Fibrillation Who Undergo Percutaneous Coronary Intervention
NCT01830543, Phase 3, Completed, Janssen Scientific Affairs, LLC; results first posted 2017-07-31
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study Exploring Two Strategies of Rivaroxaban (JNJ39039039; BAY-59-7939) and One of Oral Vitamin K Antagonist in Patients With Atrial Fibrillation Who Undergo Percutaneous Coronary Intervention. Trials, record NCT01830543. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01830543
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study Exploring Two Strategies of Rivaroxaban (JNJ39039039; BAY-59-7939) and One of Oral Vitamin K Antagonist in Patients With Atrial Fibrillation Who Undergo Percutaneous Coronary Intervention
- NCT number
- NCT01830543
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,124 participants, actual
- Lead sponsor
- Janssen Scientific Affairs, LLC
- Conditions
- Atrial Fibrillation, Percutaneous Coronary Intervention
- Interventions
- rivaroxaban 2.5 mg, rivaroxaban 15 mg, rivaroxaban 10 mg, aspirin (ASA), vitamin K antagonist (VKA), clopidogrel, prasugrel, ticagrelor
- First posted
- 2013-04-12
- Last updated
- 2017-09-19
- Other registries' IDs
- eudract:2012-001491-11
- Results first posted
- 2017-07-31
- Limitations and caveats
First the stratification to either 1, 6 or 12 months of DAPT was based upon clinician choice and was not randomized. Secondly there was not sufficient power to definitively assess efficacy due to the modest number of adverse CV events.
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Clinically Significant Bleeding | Up to Month 12 | Clinically significant bleeding is a composite of Thrombolysis in Myocardial Infarction (TIMI) major bleeding, minor bleeding, and bleeding requiring medical attention (BRMA). TIMI major bleeding is defined as any symptomatic intracranial hemorrhage, clinically overt signs of hemorrhage (including imaging) associated with a drop in hemoglobin of greater than or equal to (\>=) 5 grams per deciliter (g/dL) (or when the hemoglobin concentration is not available, an absolute drop in hematocrit of \>=15 percent (%)). TIMI minor bleeding event is defined as any clinically overt sign of hemorrhage (including imaging) that is associated with a fall in hemoglobin concentration of 3 to less than (\<) 5 g/dL (or, when hemoglobin concentration is not available, a fall in hematocrit of 9 percent to \<15 percent). A BRMA event is defined as any bleeding event that requires medical treatment, surgical treatment, or laboratory evaluation, and does not meet criteria for a major or minor bleeding event. |
| Secondary | Percentage of Participants With Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding | Up to Month 12 and end of DAPT-Month 1, 6 and 12 | TIMI major bleeding is defined as any symptomatic intracranial hemorrhage, Clinically overt signs of hemorrhage (including imaging) associated with a drop in hemoglobin of \>= 5 g/dL (or when the hemoglobin concentration is not available, an absolute drop in hematocrit of \>=15 percent). |
| Secondary | Percentage of Participants With Thrombolysis in Myocardial Infarction (TIMI) Minor Bleeding | Up to Month 12 and end of DAPT-Month 1, 6 and 12 | TIMI minor bleeding event is defined as any clinically overt sign of hemorrhage (including imaging) that is associated with a fall in hemoglobin concentration of 3 to \<5 g/dL (or, when hemoglobin concentration is not available, a fall in hematocrit of 9 percent to \<15 percent). |
| Secondary | Percentage of Participants With Bleeding Requiring Medical Attention (BRMA) | Up to Month 12 and end of DAPT-Month 1, 6 and 12 | A BRMA event is defined as any bleeding event that requires medical treatment, surgical treatment, or laboratory evaluation, and does not meet criteria for a major or minor bleeding event. |
| Secondary | Percentage of Participants With Composite of Adverse Cardiovascular Events (Cardiovascular Death, Myocardial Infarction (MI) and Stroke) | Up to Month 12 and end of DAPT-Month 1, 6 and 12 | Percentage of participants who experienced adverse cardiovascular events (cardiovascular death, myocardial Infarction (MI) and stroke) collectively, were assessed. |
| Secondary | Percentage of Participants With Cardiovascular Death | Up to Month 12 and end of DAPT-Month 1, 6 and 12 | The percentage of participants with the first occurrence of cardiovascular death were evaluated. |
| Secondary | Percentage of Participants With Myocardial Infarction | Up to Month 12 and end of DAPT-Month 1, 6 and 12 | The percentage of participants with the first occurrence of Myocardial Infarction were evaluated. |
| Secondary | Percentage of Participants With Stroke | Up to Month 12 and end of DAPT-Month 1, 6 and 12 | The percentage of participants with the first occurrence of Stroke were evaluated. |
| Secondary | Percentage of Participants With Stent Thrombosis | Up to Month 12 and end of DAPT-Month 1, 6 and 12 | The percentage of participants with the first occurrence of stent thrombosis were evaluated. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Clinically Significant Bleeding | Up to Month 12 | The safety analysis set is defined as all randomized participants who received at least 1 dose of study drug. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding | Up to Month 12 and end of DAPT-Month 1, 6 and 12 | The safety analysis set is defined as all randomized participants who received at least 1 dose of study drug. Here, 'n' signifies number of participants analyzed at specific time-point in this outcome measure. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Thrombolysis in Myocardial Infarction (TIMI) Minor Bleeding | Up to Month 12 and end of DAPT-Month 1, 6 and 12 | The safety analysis set is defined as all randomized participants who received at least 1 dose of study drug. Here 'n' signifies number of participants analyzed at specific time-point in this outcome measure. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Bleeding Requiring Medical Attention (BRMA) | Up to Month 12 and end of DAPT-Month 1, 6 and 12 | The safety analysis set is defined as all randomized participants who received at least 1 dose of study drug. Here 'n' signifies number of participants analyzed at specific time-point in this outcome measure. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Composite of Adverse Cardiovascular Events (Cardiovascular Death, Myocardial Infarction (MI) and Stroke) | Up to Month 12 and end of DAPT-Month 1, 6 and 12 | The safety analysis set is defined as all randomized participants who received at least 1 dose of study drug. Here 'N' signifies number of participants who were evaluable for this outcome measure, 'n' signifies number of participants analyzed at specific time-point in this outcome measure. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Cardiovascular Death | Up to Month 12 and end of DAPT-Month 1, 6 and 12 | The safety analysis set is defined as all randomized participants who received at least 1 dose of study drug. Here 'N' signifies number of participants who were evaluable for this outcome measure, 'n' signifies number of participants analyzed at specific time-point in this outcome measure. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Myocardial Infarction | Up to Month 12 and end of DAPT-Month 1, 6 and 12 | The safety analysis set is defined as all randomized participants who received at least 1 dose of study drug. Here 'N' signifies number of participants who were evaluable for this outcome measure, 'n' signifies number of participants analyzed at specific time-point in this outcome measure. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Stroke | Up to Month 12 and end of DAPT-Month 1, 6 and 12 | The safety analysis set is defined as all randomized participants who received at least 1 dose of study drug. Here 'N' signifies number of participants who were evaluable for this outcome measure, 'n' signifies number of participants analyzed at specific time-point in this outcome measure. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Stent Thrombosis | Up to Month 12 and end of DAPT-Month 1, 6 and 12 | The safety analysis set is defined as all randomized participants who received at least 1 dose of study drug. Here 'N' signifies number of participants who were evaluable for this outcome measure, 'n' signifies number of participants analyzed at specific time-point in this outcome measure. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group99
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Clinically Significant Bleeding | Rivaroxaban 15 mg | 15.7 | percentage of participants | ||
| Percentage of Participants With Clinically Significant Bleeding | Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD) | 16.6 | percentage of participants | ||
| Percentage of Participants With Clinically Significant Bleeding | Vitamin K Antagonist (VKA) | 24.0 | percentage of participants | ||
| Percentage of Participants With Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding | Rivaroxaban 15 mg | Up to Month 12 (n= 696, 706, 697) | 2.0 | percentage of participants | |
| Percentage of Participants With Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding | Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD) | Up to Month 12 (n= 696, 706, 697) | 1.7 | percentage of participants | |
| Percentage of Participants With Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding | Vitamin K Antagonist (VKA) | Up to Month 12 (n= 696, 706, 697) | 2.9 | percentage of participants | |
| Percentage of Participants With Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding | Rivaroxaban 15 mg | End of DAPT-1 Month (n= 0, 108,113) | NA | percentage of participants | |
| Percentage of Participants With Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding | Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD) | End of DAPT-1 Month (n= 0, 108,113) | 0.9 | percentage of participants | |
| Percentage of Participants With Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding | Vitamin K Antagonist (VKA) | End of DAPT-1 Month (n= 0, 108,113) | 4.4 | percentage of participants | |
| Percentage of Participants With Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding | Rivaroxaban 15 mg | End of DAPT-6 Month (n= 0, 248,243) | NA | percentage of participants |
1 to 10 of 99Source ClinicalTrials.gov
See all 99 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Rivaroxaban 15 mg | 709 | |
| Overall Study | STARTED | Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD) | 709 | |
| Overall Study | STARTED | Vitamin K Antagonist (VKA) | 706 | |
| Overall Study | Treated | Rivaroxaban 15 mg | 696 | |
| Overall Study | Treated | Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD) | 706 | |
| Overall Study | Treated | Vitamin K Antagonist (VKA) | 697 | |
| Overall Study | COMPLETED | Rivaroxaban 15 mg | 550 | |
| Overall Study | COMPLETED | Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD) | 557 | |
| Overall Study | COMPLETED | Vitamin K Antagonist (VKA) | 492 | |
| Overall Study | NOT COMPLETED | Rivaroxaban 15 mg | 159 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events1,230
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 | Angina Pectoris | Cardiac disorders | Rivaroxaban 15 mg | 13 | 696 | |
| other | Angina Pectoris | Cardiac disorders | Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD) | 18 | 706 | |
| other | Angina Pectoris | Cardiac disorders | Vitamin K Antagonist (VKA) | 12 | 697 | |
| other | Diarrhoea | Gastrointestinal disorders | Rivaroxaban 15 mg | 12 | 696 | |
| other | Diarrhoea | Gastrointestinal disorders | Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD) | 18 | 706 | |
| other | Diarrhoea | Gastrointestinal disorders | Vitamin K Antagonist (VKA) | 11 | 697 | |
| other | Gingival Bleeding | Gastrointestinal disorders | Rivaroxaban 15 mg | 17 | 696 | |
| other | Gingival Bleeding | Gastrointestinal disorders | Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD) | 16 | 706 | |
| other | Gingival Bleeding | Gastrointestinal disorders | Vitamin K Antagonist (VKA) | 18 | 697 | |
| other | Oedema Peripheral | General disorders | Rivaroxaban 15 mg | 14 | 696 |
1 to 10 of 1,230Source ClinicalTrials.gov
See all 1,230 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Rivaroxaban 15 mg | ||
| Total, all-cause mortality | Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD) | ||
| Total, all-cause mortality | Vitamin K Antagonist (VKA) | ||
| Total, other adverse events | Rivaroxaban 15 mg | 174 | 696 |
| Total, other adverse events | Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD) | 210 | 706 |
| Total, other adverse events | Vitamin K Antagonist (VKA) | 234 | 697 |
| Total, serious adverse events | Rivaroxaban 15 mg | 237 | 696 |
| Total, serious adverse events | Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD) | 225 | 706 |
| Total, serious adverse events | Vitamin K Antagonist (VKA) | 271 | 697 |
Source ClinicalTrials.gov
Papers9
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
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/NCT01830543
GET https://conductscience.org/api/trials/v1/NCT01830543/results?page=2