AzTrials
AzTrials

Atrial FibrillationPhase 3PIONEER AF-PCINCT01830543

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

A Phase 3 study testing rivaroxaban 2.5 mg, rivaroxaban 15 mg and rivaroxaban 10 mg in people with Atrial Fibrillation and Percutaneous Coronary Intervention, run by Janssen Scientific Affairs, LLC at 348 sites in 25 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
rivaroxaban 2.5 mg, rivaroxaban 15 mg and rivaroxaban 10 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,124 participants
Where
348 sitesin 25 countries
Study dates
10 May 2013to 28 Jul 2016
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

348 sites in 25 countries.

348 sites in 25 countries

United States86 sites

  • Study site

    Abington, Pennsylvania

  • Study site

    Albuquerque, New Mexico

  • Study site

    Atlantis, Florida

  • Study site

    Auburn, Maine

  • Study site

    Austin, Texas

  • Study site

    Baltimore, Maryland

  • Study site

    Bangor, Maine

  • Study site

    Bartlesville, Oklahoma

  • Study site

    Bellevue, Washington

  • Study site

    Bend, Oregon

  • Study site

    Boise, Idaho

  • Study site

    Camp Hill, Pennsylvania

  • Study site

    Charlottesville, Virginia

  • Study site

    Clearwater, Florida

  • Study site

    Colorado Springs, Colorado

  • Study site

    Columbus, Georgia

  • Study site

    Danbury, Connecticut

  • Study site

    Daytona Beach, Florida

  • Study site

    Detroit, Michigan

  • Study site

    Doylestown, Pennsylvania

  • Study site

    Erie, Pennsylvania

  • Study site

    Fort Worth, Texas

  • Study site

    Greenville, South Carolina

  • Study site

    Hackensack, New Jersey

  • Study site

    Haddon Heights, New Jersey

  • Study site

    Hammond, Louisiana

  • Study site

    Hazel Crest, Illinois

  • Study site

    Humble, Texas

  • Study site

    Huntsville, Alabama

  • Study site

    Indianapolis, Indiana

  • Study site

    Jackson, Tennessee

  • Study site

    Jacksonville, Florida

  • Study site

    Kalispell, Montana

  • Study site

    Kansas City, Missouri

  • Study site

    Knoxville, Tennessee

  • Study site

    Lake Charles, Louisiana

  • Study site

    Lakewood, Colorado

  • Study site

    Lansing, Michigan

  • Study site

    Las Vegas, Nevada

  • Study site

    Layton, Utah

  • Study site

    Littleton, Colorado

  • Study site

    Los Alamitos, California

  • Study site

    Macon, Georgia

  • Study site

    Manassas, Virginia

  • Study site

    Marietta, Georgia

  • Study site

    Midlothian, Virginia

  • Study site

    Milwaukee, Wisconsin

  • Study site

    Mission Viejo, California

  • Study site

    Mount Clemens, Michigan

  • Study site

    Mt. Pleasant, South Carolina

  • Study site

    Munster, Indiana

  • Study site

    New Brunswick, New Jersey

  • Study site

    New York, New York

  • Study site

    Newark, New Jersey

  • Study site

    Oceanside, California

  • Study site

    Odessa, Texas

  • Study site

    Oklahoma City, Oklahoma

  • Study site

    Peekskill, New York

  • Study site

    Petoskey, Michigan

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Plano, Texas

  • Study site

    Port Charlotte, Florida

  • Study site

    Portland, Oregon

  • Study site

    Rapid City, South Dakota

  • Study site

    Richmond, Virginia

  • Study site

    Ridgewood, New Jersey

  • Study site

    Riverside, California

  • Study site

    Sacramento, California

  • Study site

    Safety Harbor, Florida

  • Study site

    San Francisco, California

  • Study site

    Sanford, North Carolina

  • Study site

    Sayre, Pennsylvania

  • Study site

    Seattle, Washington

  • Study site

    Slidell, Louisiana

  • Study site

    St Louis, Missouri

  • Study site

    St. Petersburg, Florida

  • Study site

    Stockton, California

  • Study site

    Tallahassee, Florida

  • Study site

    Tampa, Florida

  • Study site

    Thousand Oaks, California

  • Study site

    Torrance, California

  • Study site

    Tulsa, Oklahoma

  • Study site

    Washington D.C., District of Columbia

  • Study site

    Weston, Wisconsin

  • Study site

    York, Pennsylvania

  • Study site

    Ypsilanti, Michigan

Other trials in United States

United Kingdom23 sites

  • Study site

    Bath

  • Study site

    Birmingham

  • Study site

    Blackburn

  • Study site

    Bradford

  • Study site

    Clydebank

  • Study site

    Cottingham

  • Study site

    Coventry

  • Study site

    Dorchester

  • Study site

    Dundee

  • Study site

    Edinburgh

  • Study site

    Exeter

  • Study site

    Hampshire

  • Study site

    Harrow

  • Study site

    High Wycombe

  • Study site

    London

  • Study site

    Middlesbrough

  • Study site

    Norwich

  • Study site

    Nottingham

  • Study site

    Plymouth

  • Study site

    Portsmouth

  • Study site

    Torquay

  • Study site

    Truro

  • Study site

    Worcester

Other trials in United Kingdom

Poland22 sites

  • Study site

    Będzin

  • Study site

    Bielsko-Biala

  • Study site

    Chrzanów

  • Study site

    Gdynia

  • Study site

    Grodzisk Mazowiecki

  • Study site

    Katowice

  • Study site

    Krakow

  • Study site

    Lodz

  • Study site

    Mielec

  • Study site

    Nowy Targ

  • Study site

    Ostrowiec Świętokrzyski

  • Study site

    Oświęcim

  • Study site

    Płock

  • Study site

    Rzeszow Poland

  • Study site

    Starachowice

  • Study site

    Starogard Gdański

  • Study site

    Szczecin

  • Study site

    Torun

  • Study site

    Tychy

  • Study site

    Ustroń

  • Study site

    Warsaw

  • Study site

    Zamość

Other trials in Poland

Germany16 sites

  • Study site

    Bad Friedrichshall

  • Study site

    Bad Nauheim

  • Study site

    Berlin

  • Study site

    Cologne

  • Study site

    Dresden

  • Study site

    Esslingen am Neckar

  • Study site

    Frankfurt am Main

  • Study site

    Freiburg im Breisgau

  • Study site

    Göttingen

  • Study site

    Greifswald

  • Study site

    Hamburg

  • Study site

    Heidelberg

  • Study site

    Limburg

  • Study site

    Mannheim

  • Study site

    Ulm

  • Study site

    Witten

Other trials in Germany

Russia16 sites

  • Study site

    Arkhangelsk

  • Study site

    Barnaul

  • Study site

    Chita

  • Study site

    Kemerovo

  • Study site

    Krasnodar

  • Study site

    Krasnoyarsk

  • Study site

    Moscow

  • Study site

    Nizhny Novgorod

  • Study site

    Perm

  • Study site

    Rostov-on-Don

  • Study site

    Saint Petersburg

  • Study site

    Samara

  • Study site

    Saratov

  • Study site

    Syktyvkar

  • Study site

    Tyumen

  • Study site

    Yekaterinburg

Other trials in Russia

Canada15 sites

  • Study site

    Chicoutimi

  • Study site

    Edmonton, Alberta

  • Study site

    Greater Sudbury, Ontario

  • Study site

    London, Ontario

  • Study site

    Maple Ridge, British Columbia

  • Study site

    Montreal, Quebec

  • Study site

    New Westminster, British Columbia

  • Study site

    Ottawa, Ontario

  • Study site

    Québec, Quebec

  • Study site

    Saint John

  • Study site

    Sherbrooke, Quebec

  • Study site

    St. John's, Newfoundland and Labrador

  • Study site

    Toronto, Ontario

  • Study site

    Vancouver, British Columbia

  • Study site

    Victoria, British Columbia

Other trials in Canada

France15 sites

  • Study site

    Besancon Cedex Franche-Comté

  • Study site

    Caen

  • Study site

    Centrès

  • Study site

    Chartres

  • Study site

    Lille

  • Study site

    Limoges

  • Study site

    Marseille

  • Study site

    Montfermeil

  • Study site

    Nantes

  • Study site

    Nîmes

  • Study site

    Paris

  • Study site

    Pau

  • Study site

    Pessac

  • Study site

    Poitiers

  • Study site

    Toulouse

Other trials in France

Brazil14 sites

  • Study site

    Belo Horizonte

  • Study site

    Blumenau

  • Study site

    Brasília

  • Study site

    Campina Grande do Sul

  • Study site

    Campinas

  • Study site

    Curitiba

  • Study site

    Marília

  • Study site

    Passo Fundo

  • Study site

    Porto Alegre

  • Study site

    Recife

  • Study site

    São José do Rio Preto

  • Study site

    São Paulo

  • Study site

    Uberlândia

  • Study site

    Votuporanga

Other trials in Brazil

Belgium12 sites

  • Study site

    Aalst

  • Study site

    Bonheiden

  • Study site

    Brasschaat

  • Study site

    Bruges

  • Study site

    Brussels

  • Study site

    Genk

  • Study site

    Ghent

  • Study site

    Liège

  • Study site

    Mechelen

  • Study site

    Mol

  • Study site

    Roeselare

  • Study site

    Turnhout

Other trials in Belgium

Czechia12 sites

  • Study site

    Brno

  • Study site

    Hradec Králové

  • Study site

    Jablonec Na Nisou

  • Study site

    Karlovy Vary

  • Study site

    Kladno

  • Study site

    Litomyšl

  • Study site

    Olomouc

  • Study site

    Pilsen

  • Study site

    Prague

  • Study site

    Praha 10 N/A

  • Study site

    Slaný

  • Study site

    Uherské Hradiště

Other trials in Czechia

Denmark12 sites

  • Study site

    Aalborg

  • Study site

    Copenhagen

  • Study site

    Esbjerg

  • Study site

    Herlev

  • Study site

    Herning

  • Study site

    Hvidovre

  • Study site

    Koege

  • Study site

    Næstved

  • Study site

    Odense

  • Study site

    Roskilde

  • Study site

    Svendborg

  • Study site

    Vejle

Other trials in Denmark

Netherlands12 sites

  • Study site

    's-Hertogenbosch

  • Study site

    Alkmaar

  • Study site

    Amsterdam

  • Study site

    Amsterdam-Zuidoost

  • Study site

    Breda

  • Study site

    Delft

  • Study site

    Gorinchem

  • Study site

    Leiden

  • Study site

    Maastricht

  • Study site

    Nieuwegein

  • Study site

    Sneek

  • Study site

    Uden

Other trials in Netherlands

Ukraine11 sites

  • Study site

    Cherkassy

  • Study site

    Dnipro

  • Study site

    Ivano-Frankivsk

  • Study site

    Kharkiv

  • Study site

    Khemelnitskiy

  • Study site

    Kyiv

  • Study site

    Lviv

  • Study site

    Odesa

  • Study site

    Rivne

  • Study site

    Uzhhorod

  • Study site

    Zaporizhzhya

Other trials in Ukraine

Argentina10 sites

  • Study site

    Bahía Blanca

  • Study site

    Buenos Aires

  • Study site

    C.a.b.a.

  • Study site

    Córdoba

  • Study site

    Corrientes

  • Study site

    La Plata

  • Study site

    Resistencia

  • Study site

    Rosario

  • Study site

    Santa Fe

  • Study site

    Vicente López

Other trials in Argentina

Mexico9 sites

  • Study site

    Aguascalientes

  • Study site

    Guadalajara

  • Study site

    León

  • Study site

    México

  • Study site

    Pachuca

  • Study site

    Puebla City

  • Study site

    Querétaro

  • Study site

    Villahermosa

  • Study site

    Zapopan

Other trials in Mexico

South Korea9 sites

  • Study site

    Busan

  • Study site

    Daejeon

  • Study site

    Gyeonggi-do

  • Study site

    Incheon

  • Study site

    Seongnam

  • Study site

    Seoul

  • Study site

    Suwon

  • Study site

    Uijeongbu-si

  • Study site

    Wŏnju

Other trials in South Korea

Turkey (Türkiye)9 sites

  • Study site

    Ankara

  • Study site

    Antalya

  • Study site

    Bursa

  • Study site

    Gaziantep

  • Study site

    Istanbul

  • Study site

    Istanbul Nap

  • Study site

    Izmir

  • Study site

    Kayseri

  • Study site

    Sivas

Other trials in Turkey (Türkiye)

Bulgaria8 sites

  • Study site

    Blagoevgrad

  • Study site

    Burgas

  • Study site

    Pazardzhik

  • Study site

    Pleven

  • Study site

    Plovdiv

  • Study site

    Sofia

  • Study site

    Varna

  • Study site

    Veliko Tarnovo

Other trials in Bulgaria

Sweden8 sites

  • Study site

    Falun

  • Study site

    Gothenburg

  • Study site

    Jönköping

  • Study site

    Lund

  • Study site

    Malmö

  • Study site

    Örebro

  • Study site

    Stockholm

  • Study site

    Umeå

Other trials in Sweden

Australia7 sites

  • Study site

    Chermside

  • Study site

    Epping

  • Study site

    Hobart

  • Study site

    Kogarah

  • Study site

    Liverpool

  • Study site

    New Lambton

  • Study site

    Wollongong

Other trials in Australia

Chile5 sites

  • Study site

    Alto

  • Study site

    Concepción

  • Study site

    Punta Arenas

  • Study site

    Santiago

  • Study site

    Temuco

Other trials in Chile

Taiwan5 sites

  • Study site

    Kaohsiung City

  • Study site

    Taichung

  • Study site

    Tainan

  • Study site

    Taipei

  • Study site

    Taoyuan

Other trials in Taiwan

Malaysia4 sites

  • Study site

    George Town

  • Study site

    Johor Bahru

  • Study site

    Kajang

  • Study site

    Kuala Lumpur

Other trials in Malaysia

Romania4 sites

  • Study site

    Bucharest

  • Study site

    Cluj-Napoca

  • Study site

    Târgu Mureş

  • Study site

    Tg Mures

Other trials in Romania

South Africa4 sites

  • Study site

    Cape Town

  • Study site

    Centurion

  • Study site

    Linksfield West, Johannesburg

  • Study site

    Somerset West

Other trials in South Africa

About this study

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

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).

Read the 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.

Being tested
rivaroxaban 2.5 mg, rivaroxaban 15 mg, rivaroxaban 10 mg, aspirin (ASA), vitamin K antagonist (VKA)
Keywords
Atrial Fibrillation, Irregular heart beat, rivaroxaban, aspirin, clopidogrel, prasugrel, ticagrelor, vitamin K antagonist
Medical subject headings
Atrial Fibrillation, Arrhythmias, Cardiac

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • rivaroxaban 2.5 mgDrug

    One 2.5 mg tablet twice daily for up to twelve months

  • rivaroxaban 15 mgDrug

    One 15 mg tablet once daily for up to twelve months

  • rivaroxaban 10 mgDrug

    One 10 mg tablet once daily for up to twelve months

  • aspirin (ASA)Drug

    Low-dose aspirin tablet once daily for twelve months

  • vitamin K antagonist (VKA)Drug

    Dose-adjusted VKA tablet (target International Normalized Ratio (INR) 2.0 to 3.0) once daily for twelve months

  • clopidogrelDrug

    One 75 mg tablet once daily for up to twelve months

  • prasugrelDrug

    One 10 mg tablet once daily for up to twelve months

  • ticagrelorDrug

    One 90 mg tablet twice daily for up to twelve months

Study groups in NCT01830543
Study groupRoleWhat they receive
rivaroxaban 2.5 mg twice dailyExperimentalrivaroxaban 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
Receives: Drug: rivaroxaban 2.5 mg; Drug: rivaroxaban 15 mg; Drug: rivaroxaban 10 mg; Drug: aspirin (ASA); Drug: clopidogrel; Drug: prasugrel; Drug: ticagrelor
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
Receives: Drug: aspirin (ASA); Drug: vitamin K antagonist (VKA); Drug: clopidogrel; Drug: prasugrel; Drug: ticagrelor
rivaroxaban 15 mg once dailyExperimentalrivaroxaban 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
Receives: Drug: rivaroxaban 15 mg; Drug: rivaroxaban 10 mg; Drug: clopidogrel; Drug: prasugrel; Drug: ticagrelor

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to Month 12

Secondary outcomes (8)

  1. 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).

    Measured: Up to Month 12 and end of DAPT-Month 1, 6 and 12

  2. 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).

    Measured: Up to Month 12 and end of DAPT-Month 1, 6 and 12

  3. 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.

    Measured: Up to Month 12 and end of DAPT-Month 1, 6 and 12

  4. 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.

    Measured: Up to Month 12 and end of DAPT-Month 1, 6 and 12

  5. Percentage of Participants With Cardiovascular Death

    The percentage of participants with the first occurrence of cardiovascular death were evaluated.

    Measured: Up to Month 12 and end of DAPT-Month 1, 6 and 12

  6. Percentage of Participants With Myocardial Infarction

    The percentage of participants with the first occurrence of Myocardial Infarction were evaluated.

    Measured: Up to Month 12 and end of DAPT-Month 1, 6 and 12

  7. Percentage of Participants With Stroke

    The percentage of participants with the first occurrence of Stroke were evaluated.

    Measured: Up to Month 12 and end of DAPT-Month 1, 6 and 12

  8. Percentage of Participants With Stent Thrombosis

    The percentage of participants with the first occurrence of stent thrombosis were evaluated.

    Measured: Up to Month 12 and end of DAPT-Month 1, 6 and 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Apr 2013 (estimated)
  2. Study start10 May 2013
  3. Primary completion28 Jul 2016
  4. Study completion28 Jul 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
2,124 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01830543
Sponsor's protocol ID
CR100758
Other IDs
RIVAROXAFL3003, 2012-001491-11
Acronym
PIONEER AF-PCI
Status last verified
Aug 2017
First submitted
19 Mar 2013
Last updated
19 Sep 2017
Data monitoring committee
Yes
FDA-regulated device
No

Publications

  • 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.

    PubMed 31707805

  • 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.

    PubMed 31535314

  • 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.

    PubMed 30704287

  • 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.

    PubMed 30015064

  • 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.

    PubMed 29943350

  • 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.

    PubMed 29550085

  • 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.

    PubMed 27959713

  • 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.

    PubMed 27881555

  • 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.

    PubMed 25819853

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing rivaroxaban 2.5 mg, rivaroxaban 15 mg and rivaroxaban 10 mg in people with Atrial Fibrillation and Percutaneous Coronary Intervention, run by Janssen Scientific Affairs, LLC at 348 sites in 25 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 348 sites in United States, United Kingdom, Poland, Germany, Russia and 20 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Clinically Significant Bleeding (time frame: Up to Month 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01830543, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2017.

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