Back to resultsA 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 (PIONEER AF-PCI)
Primary Purpose
Atrial Fibrillation, Percutaneous Coronary Intervention
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
rivaroxaban 2.5 mg
rivaroxaban 15 mg
rivaroxaban 10 mg
aspirin (ASA)
vitamin K antagonist (VKA)
clopidogrel
prasugrel
ticagrelor
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring Atrial Fibrillation, Irregular heart beat, rivaroxaban, aspirin, clopidogrel, prasugrel, ticagrelor, vitamin K antagonist
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
rivaroxaban 2.5 mg twice daily
vitamin K antagonist (VKA)
rivaroxaban 15 mg once daily
Arm Description
rivaroxaban 2.5 mg tablet twice daily plus low-dose aspirin (ASA) 75 to 100 mg once daily and clopidogrel 75 mg tablet once daily (or prasugrel 10 mg tablet once daily or ticagrelor 90 mg tablet twice daily) followed by rivaroxaban 15 mg tablet (or 10 mg for subjects with moderate renal impairment) once daily plus low-dose ASA for 12 months
dose-adjusted vitamin K antagonist (VKA) once daily (target International Normalized Ratio (INR) 2.0 to 3.0) plus low-dose ASA, 75 to 100 mg per day, and clopidogrel 75 mg once daily (or prasugrel 10 mg tablet once daily or ticagrelor 90 mg tablet twice daily) followed by dose-adjusted VKA once daily (target INR 2.0 to 3.0 or 2.0 to 2.5 at the investigator discretion) plus low-dose ASA for 12 months
rivaroxaban 15 mg (or 10 mg for subjects with moderate renal impairment) once daily plus clopidogrel 75 mg tablet once daily (or prasugrel 10 mg tablet once daily or ticagrelor 90 mg tablet twice daily) for 12 months
Outcomes
Primary Outcome Measures
Percentage of Participants With Clinically Significant Bleeding
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 Outcome Measures
Percentage of Participants With Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding
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).
Percentage of Participants With Thrombolysis in Myocardial Infarction (TIMI) Minor Bleeding
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).
Percentage of Participants With Bleeding Requiring Medical Attention (BRMA)
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.
Percentage of Participants With Composite of Adverse Cardiovascular Events (Cardiovascular Death, Myocardial Infarction (MI) and Stroke)
Percentage of participants who experienced adverse cardiovascular events (cardiovascular death, myocardial Infarction (MI) and stroke) collectively, were assessed.
Percentage of Participants With Cardiovascular Death
The percentage of participants with the first occurrence of cardiovascular death were evaluated.
Percentage of Participants With Myocardial Infarction
The percentage of participants with the first occurrence of Myocardial Infarction were evaluated.
Percentage of Participants With Stroke
The percentage of participants with the first occurrence of Stroke were evaluated.
Percentage of Participants With Stent Thrombosis
The percentage of participants with the first occurrence of stent thrombosis were evaluated.
Full Information
NCT ID
NCT01830543
First Posted
March 19, 2013
Last Updated
August 21, 2017
Sponsor
Janssen Scientific Affairs, LLC
Collaborators
Bayer
1. Study Identification
Unique Protocol Identification Number
NCT01830543
Brief 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
Acronym
PIONEER AF-PCI
Official Title
An Open-label, Randomized, Controlled, Multicenter Study Exploring Two Treatment Strategies of Rivaroxaban and a Dose-Adjusted Oral Vitamin K Antagonist Treatment Strategy in Subjects With Atrial Fibrillation Who Undergo Percutaneous Coronary Intervention
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
May 10, 2013 (Actual)
Primary Completion Date
July 28, 2016 (Actual)
Study Completion Date
July 28, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Scientific Affairs, LLC
Collaborators
Bayer
4. Oversight
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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).
Detailed Description
This is an open-label (both physician and participant know the treatment that the participant receives), randomized (study medication is assigned by chance), multicenter clinical study assessing the safety of 2 rivaroxaban treatment strategies and one vitamin K antagonist (VKA) treatment strategy in participants, who have paroxysmal, persistent, or permanent non-valvular atrial fibrillation (AF) and have had a percutaneous coronary intervention (PCI) with stent placement.
A target of 2,100 participants will be randomized into the study, with approximately 700 participants in each treatment strategy group. The randomization will be stratified by the intended duration of DAPT (1, 6, or 12 months).
The study consists of a screening phase, a 12-month open-label treatment phase, and an end-of-treatment/early withdrawal visit. The total duration of participation in the study for each participant is approximately 12 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Percutaneous Coronary Intervention
Keywords
Atrial Fibrillation, Irregular heart beat, rivaroxaban, aspirin, clopidogrel, prasugrel, ticagrelor, vitamin K antagonist
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2124 (Actual)
8. Arms, Groups, and Interventions
Arm Title
rivaroxaban 2.5 mg twice daily
Arm Type
Experimental
Arm Description
rivaroxaban 2.5 mg tablet twice daily plus low-dose aspirin (ASA) 75 to 100 mg once daily and clopidogrel 75 mg tablet once daily (or prasugrel 10 mg tablet once daily or ticagrelor 90 mg tablet twice daily) followed by rivaroxaban 15 mg tablet (or 10 mg for subjects with moderate renal impairment) once daily plus low-dose ASA for 12 months
Arm Title
vitamin K antagonist (VKA)
Arm Type
Experimental
Arm Description
dose-adjusted vitamin K antagonist (VKA) once daily (target International Normalized Ratio (INR) 2.0 to 3.0) plus low-dose ASA, 75 to 100 mg per day, and clopidogrel 75 mg once daily (or prasugrel 10 mg tablet once daily or ticagrelor 90 mg tablet twice daily) followed by dose-adjusted VKA once daily (target INR 2.0 to 3.0 or 2.0 to 2.5 at the investigator discretion) plus low-dose ASA for 12 months
Arm Title
rivaroxaban 15 mg once daily
Arm Type
Experimental
Arm Description
rivaroxaban 15 mg (or 10 mg for subjects with moderate renal impairment) once daily plus clopidogrel 75 mg tablet once daily (or prasugrel 10 mg tablet once daily or ticagrelor 90 mg tablet twice daily) for 12 months
Intervention Type
Drug
Intervention Name(s)
rivaroxaban 2.5 mg
Intervention Description
One 2.5 mg tablet twice daily for up to twelve months
Intervention Type
Drug
Intervention Name(s)
rivaroxaban 15 mg
Intervention Description
One 15 mg tablet once daily for up to twelve months
Intervention Type
Drug
Intervention Name(s)
rivaroxaban 10 mg
Intervention Description
One 10 mg tablet once daily for up to twelve months
Intervention Type
Drug
Intervention Name(s)
aspirin (ASA)
Intervention Description
Low-dose aspirin tablet once daily for twelve months
Intervention Type
Drug
Intervention Name(s)
vitamin K antagonist (VKA)
Intervention Description
Dose-adjusted VKA tablet (target International Normalized Ratio (INR) 2.0 to 3.0) once daily for twelve months
Intervention Type
Drug
Intervention Name(s)
clopidogrel
Intervention Description
One 75 mg tablet once daily for up to twelve months
Intervention Type
Drug
Intervention Name(s)
prasugrel
Intervention Description
One 10 mg tablet once daily for up to twelve months
Intervention Type
Drug
Intervention Name(s)
ticagrelor
Intervention Description
One 90 mg tablet twice daily for up to twelve months
Primary Outcome Measure Information:
Title
Percentage of Participants With Clinically Significant Bleeding
Description
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.
Time Frame
Up to Month 12
Secondary Outcome Measure Information:
Title
Percentage of Participants With Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding
Description
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).
Time Frame
Up to Month 12 and end of DAPT-Month 1, 6 and 12
Title
Percentage of Participants With Thrombolysis in Myocardial Infarction (TIMI) Minor Bleeding
Description
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).
Time Frame
Up to Month 12 and end of DAPT-Month 1, 6 and 12
Title
Percentage of Participants With Bleeding Requiring Medical Attention (BRMA)
Description
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.
Time Frame
Up to Month 12 and end of DAPT-Month 1, 6 and 12
Title
Percentage of Participants With Composite of Adverse Cardiovascular Events (Cardiovascular Death, Myocardial Infarction (MI) and Stroke)
Description
Percentage of participants who experienced adverse cardiovascular events (cardiovascular death, myocardial Infarction (MI) and stroke) collectively, were assessed.
Time Frame
Up to Month 12 and end of DAPT-Month 1, 6 and 12
Title
Percentage of Participants With Cardiovascular Death
Description
The percentage of participants with the first occurrence of cardiovascular death were evaluated.
Time Frame
Up to Month 12 and end of DAPT-Month 1, 6 and 12
Title
Percentage of Participants With Myocardial Infarction
Description
The percentage of participants with the first occurrence of Myocardial Infarction were evaluated.
Time Frame
Up to Month 12 and end of DAPT-Month 1, 6 and 12
Title
Percentage of Participants With Stroke
Description
The percentage of participants with the first occurrence of Stroke were evaluated.
Time Frame
Up to Month 12 and end of DAPT-Month 1, 6 and 12
Title
Percentage of Participants With Stent Thrombosis
Description
The percentage of participants with the first occurrence of stent thrombosis were evaluated.
Time Frame
Up to Month 12 and end of DAPT-Month 1, 6 and 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Scientific Affairs, LLC Clinical Trial
Organizational Affiliation
Janssen Scientific Affairs, LLC
Official's Role
Study Director
Facility Information:
City
Huntsville
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Alabama
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Los Alamitos
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Mission Viejo
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Oceanside
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Riverside
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Sacramento
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Stockton
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Colorado Springs
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Danbury
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Clearwater
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Daytona Beach
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Jacksonville
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Saint Petersburg
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Tallahassee
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Tampa
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Columbus
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Macon
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Marietta
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Boise
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Hazel Crest
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Illinois
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Indianapolis
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Munster
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Hammond
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Louisiana
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Lake Charles
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Slidell
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Auburn
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Bangor
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Baltimore
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Detroit
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Lansing
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Mount Clemens
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Petoskey
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Ypsilanti
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Saint Louis
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Kalispell
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Las Vegas
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Hackensack
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Haddon Heights
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New Brunswick
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Newark
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Ridgewood
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Albuquerque
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New York
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Peekskill
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Sanford
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Bartlesville
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Oklahoma City
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Tulsa
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Bend
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Portland
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Abington
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Camp Hill
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Doylestown
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Erie
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Philadelphia
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Sayre
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York
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Greenville
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Mount Pleasant
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Rapid City
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Jackson
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Knoxville
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Austin
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Fort Worth
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Humble
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Odessa
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Plano
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Layton
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Charlottesville
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Manassas
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Midlothian
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Richmond
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Virginia
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Bellevue
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Seattle
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Milwaukee
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Weston
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Bahia Blanca
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Argentina
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Buenos Aires
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Argentina
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C.a.b.a.
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Argentina
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Cordoba
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Argentina
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Corrientes
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Argentina
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La Plata
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Argentina
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Resistencia
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Argentina
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Rosario
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Argentina
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Santa Fe
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Argentina
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Vicente Lopez
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Argentina
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Chermside N/A
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Australia
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Epping
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Hobart
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Kogarah
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Australia
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Liverpool
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Australia
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New Lambton
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Australia
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Wollongong
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Australia
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Aalst
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Belgium
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Bonheiden
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Belgium
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Brasschaat
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Belgium
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Brugge
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Belgium
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Bruxelles
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Belgium
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Genk
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Belgium
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Gent
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Belgium
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Liège
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Belgium
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Mechelen
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Belgium
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Mol
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Belgium
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Roeselare
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Belgium
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Turnhout
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Belgium
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Belo Horizonte
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Brazil
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Blumenau
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Brazil
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Brasilia
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Brazil
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Campina Grande Do Sul
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Brazil
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Campinas
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Brazil
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Curitiba
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Brazil
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Marilia
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Brazil
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Passo Fundo
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Brazil
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Porto Alegre
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Brazil
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Recife
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Brazil
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Sao Paulo
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Brazil
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São José Do Rio Preto
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Brazil
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São Paulo
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Brazil
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Uberlandia
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Brazil
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Votuporanga
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Brazil
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Blagoevgrad
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Bulgaria
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Burgas
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Bulgaria
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Pazardjik
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Bulgaria
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Pleven
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Bulgaria
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Plovdiv
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Bulgaria
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Sofia
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Bulgaria
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Varna
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Bulgaria
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Veliko Tarnovo
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Bulgaria
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Edmonton
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Alberta
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Canada
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Maple Ridge
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British Columbia
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Canada
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New Westminster
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British Columbia
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Canada
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Vancouver
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British Columbia
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Canada
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Victoria
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British Columbia
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Canada
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St. John'S
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Newfoundland and Labrador
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Canada
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London
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Ontario
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Canada
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Ottawa
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Ontario
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Canada
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Sudbury
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Ontario
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Canada
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Toronto
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Ontario
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Canada
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Montreal
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Quebec
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Canada
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Sherbrooke
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Quebec
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Canada
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Chicoutimi
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Canada
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Quebec
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Canada
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Saint John
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Canada
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Alto
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Chile
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Concepcion
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Chile
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Punta Arenas
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Chile
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Santiago
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Chile
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Temuco
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Chile
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Brno 2
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Czechia
City
Brno
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Czechia
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Hradec Kralove
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Czechia
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Jablonec Na Nisou
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Czechia
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Karlovy Vary
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Czechia
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Kladno
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Czechia
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Litomysl
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Czechia
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Olomouc
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Czechia
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Plzen
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Czechia
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Praha 10 N/A
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Czechia
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Praha 2
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Czechia
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Praha
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Czechia
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Slany
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Czechia
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Uherske Hradiste
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Czechia
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Aalborg
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Denmark
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Copenhagen
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Denmark
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Esbjerg
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Denmark
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Herlev
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Denmark
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Herning
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Denmark
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Hvidovre
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Denmark
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Koege
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Denmark
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Naestved
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Denmark
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Odense
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Denmark
City
Roskilde
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Denmark
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Svendborg N/A
Country
Denmark
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Vejle
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Denmark
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Besancon Cedex Franche-Comté
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France
City
Caen Cedex 9
Country
France
City
Centres
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France
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Chartres
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France
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Lille
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France
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Limoges Cedex
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France
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12. IPD Sharing Statement
Citations:
PubMed Identifier
31707805
Citation
Kerneis M, Yee MK, Mehran R, Nafee T, Bode C, Halperin JL, Peterson ED, Verheugt FWA, Wildgoose P, van Eickels M, Lip GYH, Cohen M, Fox KAA, Gibson CM. Novel Oral Anticoagulant Based Versus Vitamin K Antagonist Based Double Therapy Among Stented Patients With Atrial Fibrillation: Insights From the PIONEER AF-PCI Trial. Circ Cardiovasc Interv. 2019 Nov;12(11):e008160. doi: 10.1161/CIRCINTERVENTIONS.119.008160. Epub 2019 Nov 11.
Results Reference
derived
PubMed Identifier
31535314
Citation
Gibson WJ, Nafee T, Travis R, Yee M, Kerneis M, Ohman M, Gibson CM. Machine learning versus traditional risk stratification methods in acute coronary syndrome: a pooled randomized clinical trial analysis. J Thromb Thrombolysis. 2020 Jan;49(1):1-9. doi: 10.1007/s11239-019-01940-8.
Results Reference
derived
PubMed Identifier
30704287
Citation
Kerneis M, Yee MK, Mehran R, Nafee T, Bode C, Halperin JL, Peterson ED, Verheugt FWA, Wildgoose P, van Eickels M, Lip GYH, Cohen M, Fox KAA, Gibson CM. Association of International Normalized Ratio Stability and Bleeding Outcomes Among Atrial Fibrillation Patients Undergoing Percutaneous Coronary Intervention. Circ Cardiovasc Interv. 2019 Feb;12(2):e007124. doi: 10.1161/CIRCINTERVENTIONS.118.007124.
Results Reference
derived
PubMed Identifier
30015064
Citation
Chi G, Kerneis M, Kalayci A, Liu Y, Mehran R, Bode C, Halperin JL, Verheugt FWA, Wildgoose P, van Eickels M, Lip GYH, Cohen M, Peterson ED, Fox KAA, Gibson CM. 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. Am Heart J. 2018 Sep;203:17-24. doi: 10.1016/j.ahj.2018.06.003. Epub 2018 Jun 13.
Results Reference
derived
PubMed Identifier
29943350
Citation
Chi G, Yee MK, Kalayci A, Kerneis M, AlKhalfan F, Mehran R, Bode C, Halperin JL, Verheugt FWA, Wildgoose P, van Eickels M, Lip GYH, Cohen M, Peterson ED, Fox KAA, Gibson CM. Total bleeding with rivaroxaban versus warfarin in patients with atrial fibrillation receiving antiplatelet therapy after percutaneous coronary intervention. J Thromb Thrombolysis. 2018 Oct;46(3):346-350. doi: 10.1007/s11239-018-1703-5.
Results Reference
derived
PubMed Identifier
29550085
Citation
Kerneis M, Gibson CM, Chi G, Mehran R, AlKhalfan F, Talib U, Pahlavani S, Mir M, Bode C, Halperin JL, Nafee T, Peterson ED, Verheugt FWA, Wildgoose P, van Eickels M, Lip GYH, Fox KAA, Cohen M. Effect of Procedure and Coronary Lesion Characteristics on Clinical Outcomes Among Atrial Fibrillation Patients Undergoing Percutaneous Coronary Intervention: Insights From the PIONEER AF-PCI Trial. JACC Cardiovasc Interv. 2018 Apr 9;11(7):626-634. doi: 10.1016/j.jcin.2017.11.009. Epub 2018 Mar 14.
Results Reference
derived
PubMed Identifier
27959713
Citation
Gibson CM, Mehran R, Bode C, Halperin J, Verheugt FW, Wildgoose P, Birmingham M, Ianus J, Burton P, van Eickels M, Korjian S, Daaboul Y, Lip GY, Cohen M, Husted S, Peterson ED, Fox KA. Prevention of Bleeding in Patients with Atrial Fibrillation Undergoing PCI. N Engl J Med. 2016 Dec 22;375(25):2423-2434. doi: 10.1056/NEJMoa1611594. Epub 2016 Nov 14.
Results Reference
derived
PubMed Identifier
27881555
Citation
Gibson CM, Pinto DS, Chi G, Arbetter D, Yee M, Mehran R, Bode C, Halperin J, Verheugt FW, Wildgoose P, Burton P, van Eickels M, Korjian S, Daaboul Y, Jain P, Lip GY, Cohen M, Peterson ED, Fox KA. Recurrent Hospitalization Among Patients With Atrial Fibrillation Undergoing Intracoronary Stenting Treated With 2 Treatment Strategies of Rivaroxaban or a Dose-Adjusted Oral Vitamin K Antagonist Treatment Strategy. Circulation. 2017 Jan 24;135(4):323-333. doi: 10.1161/CIRCULATIONAHA.116.025783. Epub 2016 Nov 14. Erratum In: Circulation. 2017 Mar 21;135(12 ):e789.
Results Reference
derived
PubMed Identifier
25819853
Citation
Gibson CM, Mehran R, Bode C, Halperin J, Verheugt F, Wildgoose P, van Eickels M, Lip GY, Cohen M, Husted S, Peterson E, Fox K. An open-label, randomized, controlled, multicenter study exploring two treatment strategies of rivaroxaban and a dose-adjusted oral vitamin K antagonist treatment strategy in subjects with atrial fibrillation who undergo percutaneous coronary intervention (PIONEER AF-PCI). Am Heart J. 2015 Apr;169(4):472-8.e5. doi: 10.1016/j.ahj.2014.12.006. Epub 2014 Dec 20.
Results Reference
derived
Learn more about this trial
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
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