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 ID: NCT01830543
Last Updated: 2017-09-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
2124 participants
INTERVENTIONAL
2013-05-10
2016-07-28
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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rivaroxaban 2.5 mg twice daily
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
rivaroxaban 2.5 mg
One 2.5 mg tablet twice daily for up to twelve months
rivaroxaban 15 mg
One 15 mg tablet once daily for up to twelve months
rivaroxaban 10 mg
One 10 mg tablet once daily for up to twelve months
aspirin (ASA)
Low-dose aspirin tablet once daily for twelve months
clopidogrel
One 75 mg tablet once daily for up to twelve months
prasugrel
One 10 mg tablet once daily for up to twelve months
ticagrelor
One 90 mg tablet twice daily for up to twelve months
vitamin K antagonist (VKA)
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
aspirin (ASA)
Low-dose aspirin tablet once daily for twelve months
vitamin K antagonist (VKA)
Dose-adjusted VKA tablet (target International Normalized Ratio (INR) 2.0 to 3.0) once daily for twelve months
clopidogrel
One 75 mg tablet once daily for up to twelve months
prasugrel
One 10 mg tablet once daily for up to twelve months
ticagrelor
One 90 mg tablet twice daily for up to twelve months
rivaroxaban 15 mg once daily
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
rivaroxaban 15 mg
One 15 mg tablet once daily for up to twelve months
rivaroxaban 10 mg
One 10 mg tablet once daily for up to twelve months
clopidogrel
One 75 mg tablet once daily for up to twelve months
prasugrel
One 10 mg tablet once daily for up to twelve months
ticagrelor
One 90 mg tablet twice daily for up to twelve months
Interventions
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rivaroxaban 2.5 mg
One 2.5 mg tablet twice daily for up to twelve months
rivaroxaban 15 mg
One 15 mg tablet once daily for up to twelve months
rivaroxaban 10 mg
One 10 mg tablet once daily for up to twelve months
aspirin (ASA)
Low-dose aspirin tablet once daily for twelve months
vitamin K antagonist (VKA)
Dose-adjusted VKA tablet (target International Normalized Ratio (INR) 2.0 to 3.0) once daily for twelve months
clopidogrel
One 75 mg tablet once daily for up to twelve months
prasugrel
One 10 mg tablet once daily for up to twelve months
ticagrelor
One 90 mg tablet twice daily for up to twelve months
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Janssen Scientific Affairs, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Scientific Affairs, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Scientific Affairs, LLC
Locations
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Huntsville, Alabama, United States
Los Alamitos, California, United States
Mission Viejo, California, United States
Oceanside, California, United States
Riverside, California, United States
Sacramento, California, United States
San Francisco, California, United States
Stockton, California, United States
Thousand Oaks, California, United States
Torrance, California, United States
Colorado Springs, Colorado, United States
Lakewood, Colorado, United States
Littleton, Colorado, United States
Danbury, Connecticut, United States
Washington D.C., District of Columbia, United States
Atlantis, Florida, United States
Clearwater, Florida, United States
Daytona Beach, Florida, United States
Jacksonville, Florida, United States
Port Charlotte, Florida, United States
Safety Harbor, Florida, United States
St. Petersburg, Florida, United States
Tallahassee, Florida, United States
Tampa, Florida, United States
Columbus, Georgia, United States
Macon, Georgia, United States
Marietta, Georgia, United States
Boise, Idaho, United States
Hazel Crest, Illinois, United States
Indianapolis, Indiana, United States
Munster, Indiana, United States
Hammond, Louisiana, United States
Lake Charles, Louisiana, United States
Slidell, Louisiana, United States
Auburn, Maine, United States
Bangor, Maine, United States
Baltimore, Maryland, United States
Detroit, Michigan, United States
Lansing, Michigan, United States
Mount Clemens, Michigan, United States
Petoskey, Michigan, United States
Ypsilanti, Michigan, United States
Kansas City, Missouri, United States
St Louis, Missouri, United States
Kalispell, Montana, United States
Las Vegas, Nevada, United States
Hackensack, New Jersey, United States
Haddon Heights, New Jersey, United States
New Brunswick, New Jersey, United States
Newark, New Jersey, United States
Ridgewood, New Jersey, United States
Albuquerque, New Mexico, United States
New York, New York, United States
Peekskill, New York, United States
Sanford, North Carolina, United States
Bartlesville, Oklahoma, United States
Oklahoma City, Oklahoma, United States
Tulsa, Oklahoma, United States
Bend, Oregon, United States
Portland, Oregon, United States
Abington, Pennsylvania, United States
Camp Hill, Pennsylvania, United States
Doylestown, Pennsylvania, United States
Erie, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Sayre, Pennsylvania, United States
York, Pennsylvania, United States
Greenville, South Carolina, United States
Mt. Pleasant, South Carolina, United States
Rapid City, South Dakota, United States
Jackson, Tennessee, United States
Knoxville, Tennessee, United States
Austin, Texas, United States
Fort Worth, Texas, United States
Humble, Texas, United States
Odessa, Texas, United States
Plano, Texas, United States
Layton, Utah, United States
Charlottesville, Virginia, United States
Manassas, Virginia, United States
Midlothian, Virginia, United States
Richmond, Virginia, United States
Bellevue, Washington, United States
Seattle, Washington, United States
Milwaukee, Wisconsin, United States
Weston, Wisconsin, United States
Bahía Blanca, , Argentina
Buenos Aires, , Argentina
C.a.b.a., , Argentina
Corrientes, , Argentina
Córdoba, , Argentina
La Plata, , Argentina
Resistencia, , Argentina
Rosario, , Argentina
Santa Fe, , Argentina
Vicente López, , Argentina
Chermside, , Australia
Epping, , Australia
Hobart, , Australia
Kogarah, , Australia
Liverpool, , Australia
New Lambton, , Australia
Wollongong, , Australia
Aalst, , Belgium
Bonheiden, , Belgium
Brasschaat, , Belgium
Bruges, , Belgium
Brussels, , Belgium
Genk, , Belgium
Ghent, , Belgium
Liège, , Belgium
Mechelen, , Belgium
Mol, , Belgium
Roeselare, , Belgium
Turnhout, , Belgium
Belo Horizonte, , Brazil
Blumenau, , Brazil
Brasília, , Brazil
Campina Grande do Sul, , Brazil
Campinas, , Brazil
Curitiba, , Brazil
Marília, , Brazil
Passo Fundo, , Brazil
Porto Alegre, , Brazil
Recife, , Brazil
São José do Rio Preto, , Brazil
São Paulo, , Brazil
Uberlândia, , Brazil
Votuporanga, , Brazil
Blagoevgrad, , Bulgaria
Burgas, , Bulgaria
Pazardzhik, , Bulgaria
Pleven, , Bulgaria
Plovdiv, , Bulgaria
Sofia, , Bulgaria
Varna, , Bulgaria
Veliko Tarnovo, , Bulgaria
Edmonton, Alberta, Canada
Maple Ridge, British Columbia, Canada
New Westminster, British Columbia, Canada
Vancouver, British Columbia, Canada
Victoria, British Columbia, Canada
St. John's, Newfoundland and Labrador, Canada
Greater Sudbury, Ontario, Canada
London, Ontario, Canada
Ottawa, Ontario, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Québec, Quebec, Canada
Sherbrooke, Quebec, Canada
Chicoutimi, , Canada
Saint John, , Canada
Alto, , Chile
Concepción, , Chile
Punta Arenas, , Chile
Santiago, , Chile
Temuco, , Chile
Brno, , Czechia
Hradec Králové, , Czechia
Jablonec Na Nisou, , Czechia
Karlovy Vary, , Czechia
Kladno, , Czechia
Litomyšl, , Czechia
Olomouc, , Czechia
Pilsen, , Czechia
Prague, , Czechia
Praha 10 N/A, , Czechia
Slaný, , Czechia
Uherské Hradiště, , Czechia
Aalborg, , Denmark
Copenhagen, , Denmark
Esbjerg, , Denmark
Herlev, , Denmark
Herning, , Denmark
Hvidovre, , Denmark
Koege, , Denmark
Næstved, , Denmark
Odense, , Denmark
Roskilde, , Denmark
Svendborg, , Denmark
Vejle, , Denmark
Besancon Cedex Franche-Comté, , France
Caen, , France
Centrès, , France
Chartres, , France
Lille, , France
Limoges, , France
Marseille, , France
Montfermeil, , France
Nantes, , France
Nîmes, , France
Paris, , France
Pau, , France
Pessac, , France
Poitiers, , France
Toulouse, , France
Bad Friedrichshall, , Germany
Bad Nauheim, , Germany
Berlin, , Germany
Cologne, , Germany
Dresden, , Germany
Esslingen am Neckar, , Germany
Frankfurt am Main, , Germany
Freiburg im Breisgau, , Germany
Göttingen, , Germany
Greifswald, , Germany
Hamburg, , Germany
Heidelberg, , Germany
Limburg, , Germany
Mannheim, , Germany
Ulm, , Germany
Witten, , Germany
George Town, , Malaysia
Johor Bahru, , Malaysia
Kajang, , Malaysia
Kuala Lumpur, , Malaysia
Aguascalientes, , Mexico
Guadalajara, , Mexico
León, , Mexico
México, , Mexico
Pachuca, , Mexico
Puebla City, , Mexico
Querétaro, , Mexico
Villahermosa, , Mexico
Zapopan, , Mexico
's-Hertogenbosch, , Netherlands
Alkmaar, , Netherlands
Amsterdam, , Netherlands
Amsterdam-Zuidoost, , Netherlands
Breda, , Netherlands
Delft, , Netherlands
Gorinchem, , Netherlands
Leiden, , Netherlands
Maastricht, , Netherlands
Nieuwegein, , Netherlands
Sneek, , Netherlands
Uden, , Netherlands
Będzin, , Poland
Bielsko-Biala, , Poland
Chrzanów, , Poland
Gdynia, , Poland
Grodzisk Mazowiecki, , Poland
Katowice, , Poland
Krakow, , Poland
Lodz, , Poland
Mielec, , Poland
Nowy Targ, , Poland
Ostrowiec Świętokrzyski, , Poland
Oświęcim, , Poland
Płock, , Poland
Rzeszow Poland, , Poland
Starachowice, , Poland
Starogard Gdański, , Poland
Szczecin, , Poland
Torun, , Poland
Tychy, , Poland
Ustroń, , Poland
Warsaw, , Poland
Zamość, , Poland
Bucharest, , Romania
Cluj-Napoca, , Romania
Târgu Mureş, , Romania
Tg Mures, , Romania
Arkhangelsk, , Russia
Barnaul, , Russia
Chita, , Russia
Kemerovo, , Russia
Krasnodar, , Russia
Krasnoyarsk, , Russia
Moscow, , Russia
Nizhny Novgorod, , Russia
Perm, , Russia
Rostov-on-Don, , Russia
Saint Petersburg, , Russia
Samara, , Russia
Saratov, , Russia
Syktyvkar, , Russia
Tyumen, , Russia
Yekaterinburg, , Russia
Cape Town, , South Africa
Centurion, , South Africa
Linksfield West, Johannesburg, , South Africa
Somerset West, , South Africa
Busan, , South Korea
Daejeon, , South Korea
Gyeonggi-do, , South Korea
Incheon, , South Korea
Seongnam, , South Korea
Seoul, , South Korea
Suwon, , South Korea
Uijeongbu-si, , South Korea
Wŏnju, , South Korea
Falun, , Sweden
Gothenburg, , Sweden
Jönköping, , Sweden
Lund, , Sweden
Malmo, , Sweden
Örebro, , Sweden
Stockholm, , Sweden
Umeå, , Sweden
Kaohsiung City, , Taiwan
Taichung, , Taiwan
Tainan City, , Taiwan
Taipei, , Taiwan
Taoyuan District, , Taiwan
Ankara, , Turkey (Türkiye)
Antalya, , Turkey (Türkiye)
Bursa, , Turkey (Türkiye)
Gaziantep, , Turkey (Türkiye)
Istanbul, , Turkey (Türkiye)
Istanbul Nap, , Turkey (Türkiye)
Izmir, , Turkey (Türkiye)
Kayseri, , Turkey (Türkiye)
Sivas, , Turkey (Türkiye)
Cherkassy, , Ukraine
Dnipro, , Ukraine
Ivano-Frankivsk, , Ukraine
Kharkiv, , Ukraine
Khemelnitskiy, , Ukraine
Kyiv, , Ukraine
Lviv, , Ukraine
Odesa, , Ukraine
Rivne, , Ukraine
Uzhhorod, , Ukraine
Zaporizhzhya, , Ukraine
Bath, , United Kingdom
Birmingham, , United Kingdom
Blackburn, , United Kingdom
Bradford, , United Kingdom
Clydebank, , United Kingdom
Cottingham, , United Kingdom
Coventry, , United Kingdom
Dorchester, , United Kingdom
Dundee, , United Kingdom
Edinburgh, , United Kingdom
Exeter, , United Kingdom
Hampshire, , United Kingdom
Harrow, , United Kingdom
High Wycombe, , United Kingdom
London, , United Kingdom
Middlesbrough, , United Kingdom
Norwich, , United Kingdom
Nottingham, , United Kingdom
Plymouth, , United Kingdom
Portsmouth, , United Kingdom
Torquay, , United Kingdom
Truro, , United Kingdom
Worcester, , United Kingdom
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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RIVAROXAFL3003
Identifier Type: OTHER
Identifier Source: secondary_id
2012-001491-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CR100758
Identifier Type: -
Identifier Source: org_study_id