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
PIONEER AF-PCI
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
3 other identifiers
interventional
2,124
25 countries
348
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 atrial-fibrillation
Started May 2013
Typical duration for phase_3 atrial-fibrillation
348 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 19, 2013
CompletedFirst Posted
Study publicly available on registry
April 12, 2013
CompletedStudy Start
First participant enrolled
May 10, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 28, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 28, 2016
CompletedResults Posted
Study results publicly available
July 31, 2017
CompletedSeptember 19, 2017
August 1, 2017
3.2 years
March 19, 2013
June 30, 2017
August 21, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Up to Month 12
Secondary Outcomes (8)
Percentage of Participants With Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding
Up to Month 12 and end of DAPT-Month 1, 6 and 12
Percentage of Participants With Thrombolysis in Myocardial Infarction (TIMI) Minor Bleeding
Up to Month 12 and end of DAPT-Month 1, 6 and 12
Percentage of Participants With Bleeding Requiring Medical Attention (BRMA)
Up to Month 12 and end of DAPT-Month 1, 6 and 12
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 With Cardiovascular Death
Up to Month 12 and end of DAPT-Month 1, 6 and 12
- +3 more secondary outcomes
Study Arms (3)
rivaroxaban 2.5 mg twice daily
EXPERIMENTALrivaroxaban 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
vitamin K antagonist (VKA)
EXPERIMENTALdose-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 once daily
EXPERIMENTALrivaroxaban 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
Interventions
One 2.5 mg tablet twice daily for up to twelve months
One 15 mg tablet once daily for up to twelve months
One 10 mg tablet once daily for up to twelve months
Low-dose aspirin tablet once daily for twelve months
Dose-adjusted VKA tablet (target International Normalized Ratio (INR) 2.0 to 3.0) once daily for twelve months
One 75 mg tablet once daily for up to twelve months
One 10 mg tablet once daily for up to twelve months
One 90 mg tablet twice daily for up to twelve months
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Janssen Scientific Affairs, LLClead
- Bayercollaborator
Study Sites (348)
Unknown Facility
Huntsville, Alabama, United States
Unknown Facility
Los Alamitos, California, United States
Unknown Facility
Mission Viejo, California, United States
Unknown Facility
Oceanside, California, United States
Unknown Facility
Riverside, California, United States
Unknown Facility
Sacramento, California, United States
Unknown Facility
San Francisco, California, United States
Unknown Facility
Stockton, California, United States
Unknown Facility
Thousand Oaks, California, United States
Unknown Facility
Torrance, California, United States
Unknown Facility
Colorado Springs, Colorado, United States
Unknown Facility
Lakewood, Colorado, United States
Unknown Facility
Littleton, Colorado, United States
Unknown Facility
Danbury, Connecticut, United States
Unknown Facility
Washington D.C., District of Columbia, United States
Unknown Facility
Atlantis, Florida, United States
Unknown Facility
Clearwater, Florida, United States
Unknown Facility
Daytona Beach, Florida, United States
Unknown Facility
Jacksonville, Florida, United States
Unknown Facility
Port Charlotte, Florida, United States
Unknown Facility
Safety Harbor, Florida, United States
Unknown Facility
St. Petersburg, Florida, United States
Unknown Facility
Tallahassee, Florida, United States
Unknown Facility
Tampa, Florida, United States
Unknown Facility
Columbus, Georgia, United States
Unknown Facility
Macon, Georgia, United States
Unknown Facility
Marietta, Georgia, United States
Unknown Facility
Boise, Idaho, United States
Unknown Facility
Hazel Crest, Illinois, United States
Unknown Facility
Indianapolis, Indiana, United States
Unknown Facility
Munster, Indiana, United States
Unknown Facility
Hammond, Louisiana, United States
Unknown Facility
Lake Charles, Louisiana, United States
Unknown Facility
Slidell, Louisiana, United States
Unknown Facility
Auburn, Maine, United States
Unknown Facility
Bangor, Maine, United States
Unknown Facility
Baltimore, Maryland, United States
Unknown Facility
Detroit, Michigan, United States
Unknown Facility
Lansing, Michigan, United States
Unknown Facility
Mount Clemens, Michigan, United States
Unknown Facility
Petoskey, Michigan, United States
Unknown Facility
Ypsilanti, Michigan, United States
Unknown Facility
Kansas City, Missouri, United States
Unknown Facility
St Louis, Missouri, United States
Unknown Facility
Kalispell, Montana, United States
Unknown Facility
Las Vegas, Nevada, United States
Unknown Facility
Hackensack, New Jersey, United States
Unknown Facility
Haddon Heights, New Jersey, United States
Unknown Facility
New Brunswick, New Jersey, United States
Unknown Facility
Newark, New Jersey, United States
Unknown Facility
Ridgewood, New Jersey, United States
Unknown Facility
Albuquerque, New Mexico, United States
Unknown Facility
New York, New York, United States
Unknown Facility
Peekskill, New York, United States
Unknown Facility
Sanford, North Carolina, United States
Unknown Facility
Bartlesville, Oklahoma, United States
Unknown Facility
Oklahoma City, Oklahoma, United States
Unknown Facility
Tulsa, Oklahoma, United States
Unknown Facility
Bend, Oregon, United States
Unknown Facility
Portland, Oregon, United States
Unknown Facility
Abington, Pennsylvania, United States
Unknown Facility
Camp Hill, Pennsylvania, United States
Unknown Facility
Doylestown, Pennsylvania, United States
Unknown Facility
Erie, Pennsylvania, United States
Unknown Facility
Philadelphia, Pennsylvania, United States
Unknown Facility
Sayre, Pennsylvania, United States
Unknown Facility
York, Pennsylvania, United States
Unknown Facility
Greenville, South Carolina, United States
Unknown Facility
Mt. Pleasant, South Carolina, United States
Unknown Facility
Rapid City, South Dakota, United States
Unknown Facility
Jackson, Tennessee, United States
Unknown Facility
Knoxville, Tennessee, United States
Unknown Facility
Austin, Texas, United States
Unknown Facility
Fort Worth, Texas, United States
Unknown Facility
Humble, Texas, United States
Unknown Facility
Odessa, Texas, United States
Unknown Facility
Plano, Texas, United States
Unknown Facility
Layton, Utah, United States
Unknown Facility
Charlottesville, Virginia, United States
Unknown Facility
Manassas, Virginia, United States
Unknown Facility
Midlothian, Virginia, United States
Unknown Facility
Richmond, Virginia, United States
Unknown Facility
Bellevue, Washington, United States
Unknown Facility
Seattle, Washington, United States
Unknown Facility
Milwaukee, Wisconsin, United States
Unknown Facility
Weston, Wisconsin, United States
Unknown Facility
Bahía Blanca, Argentina
Unknown Facility
Buenos Aires, Argentina
Unknown Facility
C.a.b.a., Argentina
Unknown Facility
Corrientes, Argentina
Unknown Facility
Córdoba, Argentina
Unknown Facility
La Plata, Argentina
Unknown Facility
Resistencia, Argentina
Unknown Facility
Rosario, Argentina
Unknown Facility
Santa Fe, Argentina
Unknown Facility
Vicente López, Argentina
Unknown Facility
Chermside, Australia
Unknown Facility
Epping, Australia
Unknown Facility
Hobart, Australia
Unknown Facility
Kogarah, Australia
Unknown Facility
Liverpool, Australia
Unknown Facility
New Lambton, Australia
Unknown Facility
Wollongong, Australia
Unknown Facility
Aalst, Belgium
Unknown Facility
Bonheiden, Belgium
Unknown Facility
Brasschaat, Belgium
Unknown Facility
Bruges, Belgium
Unknown Facility
Brussels, Belgium
Unknown Facility
Genk, Belgium
Unknown Facility
Ghent, Belgium
Unknown Facility
Liège, Belgium
Unknown Facility
Mechelen, Belgium
Unknown Facility
Mol, Belgium
Unknown Facility
Roeselare, Belgium
Unknown Facility
Turnhout, Belgium
Unknown Facility
Belo Horizonte, Brazil
Unknown Facility
Blumenau, Brazil
Unknown Facility
Brasília, Brazil
Unknown Facility
Campina Grande do Sul, Brazil
Unknown Facility
Campinas, Brazil
Unknown Facility
Curitiba, Brazil
Unknown Facility
Marília, Brazil
Unknown Facility
Passo Fundo, Brazil
Unknown Facility
Porto Alegre, Brazil
Unknown Facility
Recife, Brazil
Unknown Facility
São José do Rio Preto, Brazil
Unknown Facility
São Paulo, Brazil
Unknown Facility
Uberlândia, Brazil
Unknown Facility
Votuporanga, Brazil
Unknown Facility
Blagoevgrad, Bulgaria
Unknown Facility
Burgas, Bulgaria
Unknown Facility
Pazardzhik, Bulgaria
Unknown Facility
Pleven, Bulgaria
Unknown Facility
Plovdiv, Bulgaria
Unknown Facility
Sofia, Bulgaria
Unknown Facility
Varna, Bulgaria
Unknown Facility
Veliko Tarnovo, Bulgaria
Unknown Facility
Edmonton, Alberta, Canada
Unknown Facility
Maple Ridge, British Columbia, Canada
Unknown Facility
New Westminster, British Columbia, Canada
Unknown Facility
Vancouver, British Columbia, Canada
Unknown Facility
Victoria, British Columbia, Canada
Unknown Facility
St. John's, Newfoundland and Labrador, Canada
Unknown Facility
Greater Sudbury, Ontario, Canada
Unknown Facility
London, Ontario, Canada
Unknown Facility
Ottawa, Ontario, Canada
Unknown Facility
Toronto, Ontario, Canada
Unknown Facility
Montreal, Quebec, Canada
Unknown Facility
Québec, Quebec, Canada
Unknown Facility
Sherbrooke, Quebec, Canada
Unknown Facility
Chicoutimi, Canada
Unknown Facility
Saint John, Canada
Unknown Facility
Alto, Chile
Unknown Facility
Concepción, Chile
Unknown Facility
Punta Arenas, Chile
Unknown Facility
Santiago, Chile
Unknown Facility
Temuco, Chile
Unknown Facility
Brno, Czechia
Unknown Facility
Hradec Králové, Czechia
Unknown Facility
Jablonec Na Nisou, Czechia
Unknown Facility
Karlovy Vary, Czechia
Unknown Facility
Kladno, Czechia
Unknown Facility
Litomyšl, Czechia
Unknown Facility
Olomouc, Czechia
Unknown Facility
Pilsen, Czechia
Unknown Facility
Prague, Czechia
Unknown Facility
Praha 10 N/A, Czechia
Unknown Facility
Slaný, Czechia
Unknown Facility
Uherské Hradiště, Czechia
Unknown Facility
Aalborg, Denmark
Unknown Facility
Copenhagen, Denmark
Unknown Facility
Esbjerg, Denmark
Unknown Facility
Herlev, Denmark
Unknown Facility
Herning, Denmark
Unknown Facility
Hvidovre, Denmark
Unknown Facility
Koege, Denmark
Unknown Facility
Næstved, Denmark
Unknown Facility
Odense, Denmark
Unknown Facility
Roskilde, Denmark
Unknown Facility
Svendborg, Denmark
Unknown Facility
Vejle, Denmark
Unknown Facility
Besancon Cedex Franche-Comté, France
Unknown Facility
Caen, France
Unknown Facility
Centrès, France
Unknown Facility
Chartres, France
Unknown Facility
Lille, France
Unknown Facility
Limoges, France
Unknown Facility
Marseille, France
Unknown Facility
Montfermeil, France
Unknown Facility
Nantes, France
Unknown Facility
Nîmes, France
Unknown Facility
Paris, France
Unknown Facility
Pau, France
Unknown Facility
Pessac, France
Unknown Facility
Poitiers, France
Unknown Facility
Toulouse, France
Unknown Facility
Bad Friedrichshall, Germany
Unknown Facility
Bad Nauheim, Germany
Unknown Facility
Berlin, Germany
Unknown Facility
Cologne, Germany
Unknown Facility
Dresden, Germany
Unknown Facility
Esslingen am Neckar, Germany
Unknown Facility
Frankfurt am Main, Germany
Unknown Facility
Freiburg im Breisgau, Germany
Unknown Facility
Göttingen, Germany
Unknown Facility
Greifswald, Germany
Unknown Facility
Hamburg, Germany
Unknown Facility
Heidelberg, Germany
Unknown Facility
Limburg, Germany
Unknown Facility
Mannheim, Germany
Unknown Facility
Ulm, Germany
Unknown Facility
Witten, Germany
Unknown Facility
George Town, Malaysia
Unknown Facility
Johor Bahru, Malaysia
Unknown Facility
Kajang, Malaysia
Unknown Facility
Kuala Lumpur, Malaysia
Unknown Facility
Aguascalientes, Mexico
Unknown Facility
Guadalajara, Mexico
Unknown Facility
León, Mexico
Unknown Facility
México, Mexico
Unknown Facility
Pachuca, Mexico
Unknown Facility
Puebla City, Mexico
Unknown Facility
Querétaro, Mexico
Unknown Facility
Villahermosa, Mexico
Unknown Facility
Zapopan, Mexico
Unknown Facility
's-Hertogenbosch, Netherlands
Unknown Facility
Alkmaar, Netherlands
Unknown Facility
Amsterdam, Netherlands
Unknown Facility
Amsterdam-Zuidoost, Netherlands
Unknown Facility
Breda, Netherlands
Unknown Facility
Delft, Netherlands
Unknown Facility
Gorinchem, Netherlands
Unknown Facility
Leiden, Netherlands
Unknown Facility
Maastricht, Netherlands
Unknown Facility
Nieuwegein, Netherlands
Unknown Facility
Sneek, Netherlands
Unknown Facility
Uden, Netherlands
Unknown Facility
Będzin, Poland
Unknown Facility
Bielsko-Biala, Poland
Unknown Facility
Chrzanów, Poland
Unknown Facility
Gdynia, Poland
Unknown Facility
Grodzisk Mazowiecki, Poland
Unknown Facility
Katowice, Poland
Unknown Facility
Krakow, Poland
Unknown Facility
Lodz, Poland
Unknown Facility
Mielec, Poland
Unknown Facility
Nowy Targ, Poland
Unknown Facility
Ostrowiec Świętokrzyski, Poland
Unknown Facility
Oświęcim, Poland
Unknown Facility
Płock, Poland
Unknown Facility
Rzeszow Poland, Poland
Unknown Facility
Starachowice, Poland
Unknown Facility
Starogard Gdański, Poland
Unknown Facility
Szczecin, Poland
Unknown Facility
Torun, Poland
Unknown Facility
Tychy, Poland
Unknown Facility
Ustroń, Poland
Unknown Facility
Warsaw, Poland
Unknown Facility
Zamość, Poland
Unknown Facility
Bucharest, Romania
Unknown Facility
Cluj-Napoca, Romania
Unknown Facility
Târgu Mureş, Romania
Unknown Facility
Tg Mures, Romania
Unknown Facility
Arkhangelsk, Russia
Unknown Facility
Barnaul, Russia
Unknown Facility
Chita, Russia
Unknown Facility
Kemerovo, Russia
Unknown Facility
Krasnodar, Russia
Unknown Facility
Krasnoyarsk, Russia
Unknown Facility
Moscow, Russia
Unknown Facility
Nizhny Novgorod, Russia
Unknown Facility
Perm, Russia
Unknown Facility
Rostov-on-Don, Russia
Unknown Facility
Saint Petersburg, Russia
Unknown Facility
Samara, Russia
Unknown Facility
Saratov, Russia
Unknown Facility
Syktyvkar, Russia
Unknown Facility
Tyumen, Russia
Unknown Facility
Yekaterinburg, Russia
Unknown Facility
Cape Town, South Africa
Unknown Facility
Centurion, South Africa
Unknown Facility
Linksfield West, Johannesburg, South Africa
Unknown Facility
Somerset West, South Africa
Unknown Facility
Busan, South Korea
Unknown Facility
Daejeon, South Korea
Unknown Facility
Gyeonggi-do, South Korea
Unknown Facility
Incheon, South Korea
Unknown Facility
Seongnam, South Korea
Unknown Facility
Seoul, South Korea
Unknown Facility
Suwon, South Korea
Unknown Facility
Uijeongbu-si, South Korea
Unknown Facility
Wŏnju, South Korea
Unknown Facility
Falun, Sweden
Unknown Facility
Gothenburg, Sweden
Unknown Facility
Jönköping, Sweden
Unknown Facility
Lund, Sweden
Unknown Facility
Malmo, Sweden
Unknown Facility
Örebro, Sweden
Unknown Facility
Stockholm, Sweden
Unknown Facility
Umeå, Sweden
Unknown Facility
Kaohsiung City, Taiwan
Unknown Facility
Taichung, Taiwan
Unknown Facility
Tainan, Taiwan
Unknown Facility
Taipei, Taiwan
Unknown Facility
Taoyuan District, Taiwan
Unknown Facility
Ankara, Turkey (Türkiye)
Unknown Facility
Antalya, Turkey (Türkiye)
Unknown Facility
Bursa, Turkey (Türkiye)
Unknown Facility
Gaziantep, Turkey (Türkiye)
Unknown Facility
Istanbul, Turkey (Türkiye)
Unknown Facility
Istanbul Nap, Turkey (Türkiye)
Unknown Facility
Izmir, Turkey (Türkiye)
Unknown Facility
Kayseri, Turkey (Türkiye)
Unknown Facility
Sivas, Turkey (Türkiye)
Unknown Facility
Cherkassy, Ukraine
Unknown Facility
Dnipro, Ukraine
Unknown Facility
Ivano-Frankivsk, Ukraine
Unknown Facility
Kharkiv, Ukraine
Unknown Facility
Khemelnitskiy, Ukraine
Unknown Facility
Kyiv, Ukraine
Unknown Facility
Lviv, Ukraine
Unknown Facility
Odesa, Ukraine
Unknown Facility
Rivne, Ukraine
Unknown Facility
Uzhhorod, Ukraine
Unknown Facility
Zaporizhzhya, Ukraine
Unknown Facility
Bath, United Kingdom
Unknown Facility
Birmingham, United Kingdom
Unknown Facility
Blackburn, United Kingdom
Unknown Facility
Bradford, United Kingdom
Unknown Facility
Clydebank, United Kingdom
Unknown Facility
Cottingham, United Kingdom
Unknown Facility
Coventry, United Kingdom
Unknown Facility
Dorchester, United Kingdom
Unknown Facility
Dundee, United Kingdom
Unknown Facility
Edinburgh, United Kingdom
Unknown Facility
Exeter, United Kingdom
Unknown Facility
Hampshire, United Kingdom
Unknown Facility
Harrow, United Kingdom
Unknown Facility
High Wycombe, United Kingdom
Unknown Facility
London, United Kingdom
Unknown Facility
Middlesbrough, United Kingdom
Unknown Facility
Norwich, United Kingdom
Unknown Facility
Nottingham, United Kingdom
Unknown Facility
Plymouth, United Kingdom
Unknown Facility
Portsmouth, United Kingdom
Unknown Facility
Torquay, United Kingdom
Unknown Facility
Truro, United Kingdom
Unknown Facility
Worcester, United Kingdom
Related Publications (9)
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.
PMID: 31707805DERIVEDGibson 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.
PMID: 31535314DERIVEDKerneis 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.
PMID: 30704287DERIVEDChi 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.
PMID: 30015064DERIVEDChi 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.
PMID: 29943350DERIVEDKerneis 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.
PMID: 29550085DERIVEDGibson 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.
PMID: 27959713DERIVEDGibson 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.
PMID: 27881555DERIVEDGibson 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.
PMID: 25819853DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
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.
Results Point of Contact
- Title
- Senior Director Clinical Development
- Organization
- Janssen Scientific Affairs, LLC
Study Officials
- STUDY DIRECTOR
Janssen Scientific Affairs, LLC Clinical Trial
Janssen Scientific Affairs, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 19, 2013
First Posted
April 12, 2013
Study Start
May 10, 2013
Primary Completion
July 28, 2016
Study Completion
July 28, 2016
Last Updated
September 19, 2017
Results First Posted
July 31, 2017
Record last verified: 2017-08