Phase 3
Completed N=2,124
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
Source: ClinicalTrials.gov NCT01830543 ↗Enrolled (actual)
2,124
Serious AEs
34.9%
Results posted
Jul 2017
Primary outcomePrimary: Percentage of Participants With Clinically Significant Bleeding — 15.7; 16.6; 24.0 percentage of participants — p=<0.001
◆ Published Evidence
Established
74citations · ~12 / year
Machine learning versus traditional risk stratification methods in acute coronary syndrome: a pooled randomized clinical trial analysis.
Summary
The primary purpose of this study is to evaluate the safety for 2 different rivaroxaban treatment strategies and one Vitamin K Antagonist (VKA) treatment strategy utilizing various combinations of dual antiplatelet therapy (DAPT) or low-dose aspirin (ASA) or clopidogrel (or prasugrel or ticagrelor).
Linked Publications (5)
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Machine learning versus traditional risk stratification methods in acute coronary syndrome: a pooled randomized clinical trial analysis.
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Association of International Normalized Ratio Stability and Bleeding Outcomes Among Atrial Fibrillation Patients Undergoing Percutaneous Coronary Intervention.
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Safety and efficacy of non-vitamin K oral anticoagulant for atrial fibrillation patients after percutaneous coronary intervention: A bivariate analysis of the PIONEER AF-PCI and RE-DUAL PCI trial.
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Total bleeding with rivaroxaban versus warfarin in patients with atrial fibrillation receiving antiplatelet therapy after percutaneous coronary intervention.
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Novel Oral Anticoagulant Based Versus Vitamin K Antagonist Based Double Therapy Among Stented Patients With Atrial Fibrillation: Insights From the PIONEER AF-PCI Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Clinically Significant Bleeding |
15.7; 16.6; 24.0 | <0.001 sig |
| SECONDARY Percentage of Participants With Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding |
2.0; 1.7; 2.9; NA; 0.9; 4.4 | 0.234 |
| SECONDARY Percentage of Participants With Thrombolysis in Myocardial Infarction (TIMI) Minor Bleeding |
1.0; 1.0; 1.9; NA; 0.9; 1.8 | 0.144 |
| SECONDARY Percentage of Participants With Bleeding Requiring Medical Attention (BRMA) |
13.4; 14.4; 19.9; NA; 16.7; 18.6 | <0.001 sig |
| SECONDARY Percentage of Participants With Composite of Adverse Cardiovascular Events (Cardiovascular Death, Myocardial Infarction (MI) and Stroke) |
5.9; 5.1; 5.2; NA; 5.6; 4.5 | 0.75 |
| SECONDARY Percentage of Participants With Cardiovascular Death |
2.2; 2; 1.6; NA; 1.9; 1.8 | 0.523 |
| SECONDARY Percentage of Participants With Myocardial Infarction |
2.7; 2.4; 3; NA; 2.8; 0.9 | 0.625 |
| SECONDARY Percentage of Participants With Stroke |
1.2; 1.4; 1; NA; 1.9; 2.7 | 0.891 |
| SECONDARY Percentage of Participants With Stent Thrombosis |
0.7; 0.9; 0.6; NA; 1.9; 0.9 | 0.79 |
Eligibility Criteria
Inclusion Criteria
- Have a documented medical history of paroxysmal, persistent, or permanent non-valvular atrial fibrillation (AF)
- Have undergone percutaneous coronary intervention (PCI) procedure (with stent placement) for primary atherosclerotic disease
- Must have an international normalized ratio (INR) of 2.5 or below to be randomized
- Women must be postmenopausal before entry or practicing a highly effective method of birth control when heterosexually active
- Be willing and able to adhere to the prohibitions and restrictions specified in the study protocol
Exclusion Criteria
- Have any condition that contraindicates anticoagulant or antiplatelet therapy or would have an unacceptable risk of bleeding, such as, but not limited to: platelet count <90,000/microliter at screening, history of intracranial hemorrhage, 12 month history of clinically significant gastrointestinal bleeding, non-VKA induced elevated prothrombin time (PT) at screening
- Have anemia of unknown cause with a hemoglobin level <10 g/dL (<6.21 mmol/L)
- Have a history of stroke or Transient Ischemic Attack (TIA)
- Have a calculated Creatinine Clearance (CrCl) <30 mL/min at screening
- Have known significant liver disease or liver function test (LFT) abnormalities
- Have any severe condition that would limit life expectancy to less than 12 months
Data sourced from ClinicalTrials.gov (NCT01830543) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.