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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01830543




Registration number
NCT01830543
Ethics application status
Date submitted
19/03/2013
Date registered
12/04/2013
Date last updated
19/09/2017

Titles & IDs
Public 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
Scientific 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
Secondary ID [1] 0 0
RIVAROXAFL3003
Secondary ID [2] 0 0
CR100758
Universal Trial Number (UTN)
Trial acronym
PIONEER AF-PCI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation 0 0
Percutaneous Coronary Intervention 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - rivaroxaban 2.5 mg
Treatment: Drugs - rivaroxaban 15 mg
Treatment: Drugs - rivaroxaban 10 mg
Treatment: Drugs - aspirin (ASA)
Treatment: Drugs - vitamin K antagonist (VKA)
Treatment: Drugs - clopidogrel
Treatment: Drugs - prasugrel
Treatment: Drugs - ticagrelor

Experimental: 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

Experimental: 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

Experimental: 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


Treatment: Drugs: rivaroxaban 2.5 mg
One 2.5 mg tablet twice daily for up to twelve months

Treatment: Drugs: rivaroxaban 15 mg
One 15 mg tablet once daily for up to twelve months

Treatment: Drugs: rivaroxaban 10 mg
One 10 mg tablet once daily for up to twelve months

Treatment: Drugs: aspirin (ASA)
Low-dose aspirin tablet once daily for twelve months

Treatment: Drugs: vitamin K antagonist (VKA)
Dose-adjusted VKA tablet (target International Normalized Ratio (INR) 2.0 to 3.0) once daily for twelve months

Treatment: Drugs: clopidogrel
One 75 mg tablet once daily for up to twelve months

Treatment: Drugs: prasugrel
One 10 mg tablet once daily for up to twelve months

Treatment: Drugs: ticagrelor
One 90 mg tablet twice daily for up to twelve months
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Clinically Significant Bleeding
Timepoint [1] 0 0
Up to Month 12
Secondary outcome [1] 0 0
Percentage of Participants With Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding
Timepoint [1] 0 0
Up to Month 12 and end of DAPT-Month 1, 6 and 12
Secondary outcome [2] 0 0
Percentage of Participants With Thrombolysis in Myocardial Infarction (TIMI) Minor Bleeding
Timepoint [2] 0 0
Up to Month 12 and end of DAPT-Month 1, 6 and 12
Secondary outcome [3] 0 0
Percentage of Participants With Bleeding Requiring Medical Attention (BRMA)
Timepoint [3] 0 0
Up to Month 12 and end of DAPT-Month 1, 6 and 12
Secondary outcome [4] 0 0
Percentage of Participants With Composite of Adverse Cardiovascular Events (Cardiovascular Death, Myocardial Infarction (MI) and Stroke)
Timepoint [4] 0 0
Up to Month 12 and end of DAPT-Month 1, 6 and 12
Secondary outcome [5] 0 0
Percentage of Participants With Cardiovascular Death
Timepoint [5] 0 0
Up to Month 12 and end of DAPT-Month 1, 6 and 12
Secondary outcome [6] 0 0
Percentage of Participants With Myocardial Infarction
Timepoint [6] 0 0
Up to Month 12 and end of DAPT-Month 1, 6 and 12
Secondary outcome [7] 0 0
Percentage of Participants With Stroke
Timepoint [7] 0 0
Up to Month 12 and end of DAPT-Month 1, 6 and 12
Secondary outcome [8] 0 0
Percentage of Participants With Stent Thrombosis
Timepoint [8] 0 0
Up to Month 12 and end of DAPT-Month 1, 6 and 12

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
10/05/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
28/07/2016
Sample size
Target
Accrual to date
Final
2124
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Chermside N/A
Recruitment hospital [2] 0 0
- Epping
Recruitment hospital [3] 0 0
- Hobart
Recruitment hospital [4] 0 0
- Kogarah
Recruitment hospital [5] 0 0
- Liverpool
Recruitment hospital [6] 0 0
- New Lambton
Recruitment hospital [7] 0 0
- Wollongong
Recruitment postcode(s) [1] 0 0
- Chermside N/A
Recruitment postcode(s) [2] 0 0
- Epping
Recruitment postcode(s) [3] 0 0
- Hobart
Recruitment postcode(s) [4] 0 0
- Kogarah
Recruitment postcode(s) [5] 0 0
- Liverpool
Recruitment postcode(s) [6] 0 0
- New Lambton
Recruitment postcode(s) [7] 0 0
- Wollongong
Recruitment outside Australia
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Rosario
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Plzen
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Praha 10 N/A
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Czechia
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Praha
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Aalborg
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Esbjerg
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Odense
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Roskilde
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Nantes Cedex 1
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France
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Nimes
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France
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Freiburg
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Greifswald
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Gorinchem
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Leiden
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Maastricht
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Nieuwegein
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Sneek
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Uden
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Poland
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Bedzin
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Gdynia
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Krakow
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Lodz
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Mielec
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Nowy Targ
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Ostrowiec Swietokrzyski
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Oswiecim
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Plock
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Rzeszow Poland
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Starachowice
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Starogard Gdanski
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Szczecin
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Torun
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Tychy
Country [201] 0 0
Poland
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Worcester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Janssen Scientific Affairs, LLC
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Bayer
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/study/NCT01830543
Trial related presentations / 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.
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. Erratum In: Circulation. 2017 Mar 21;135(12):e789. doi: 10.1161/CIR.0000000000000495.
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.
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Scientific Affairs, LLC Clinical Trial
Address 0 0
Janssen Scientific Affairs, LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01830543