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)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Janssen Scientific Affairs, LLC
ClinicalTrials.gov Identifier:
NCT01830543
First received: March 19, 2013
Last updated: August 16, 2015
Last verified: August 2015
  Purpose

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).


Condition Intervention Phase
Atrial Fibrillation
Percutaneous Coronary Intervention
Drug: rivaroxaban 2.5 mg
Drug: rivaroxaban 15 mg
Drug: rivaroxaban 10 mg
Drug: aspirin (ASA)
Drug: vitamin K antagonist (VKA)
Drug: clopidogrel
Drug: prasugrel
Drug: ticagrelor
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Janssen Scientific Affairs, LLC:

Primary Outcome Measures:
  • Number of participants with clinically significant bleeding [ Time Frame: Baseline, Month 12 ] [ Designated as safety issue: Yes ]
    Clinically significant bleeding is a composite of Thrombolysis in Myocardial Infarction (TIMI) major bleeding, minor bleeding, and bleeding requiring medical attention.


Secondary Outcome Measures:
  • Number of participants with clinically significant bleeding events [ Time Frame: Day 10, day 30, Month 3, Month 6, Month 9, Month 12 ] [ Designated as safety issue: Yes ]
  • Number of participants with the adverse cardiovascular events (cardiovascular death, Myocardial Infarction, stroke, stent thrombosis) [ Time Frame: Day 10, day 30, Month 3, Month 6, Month 9, Month 12 ] [ Designated as safety issue: Yes ]
  • Number of participants with adverse events [ Time Frame: Day 10, day 30, Month 3, Month 6, Month 9, Month 12 ] [ Designated as safety issue: Yes ]
  • Event composite of clinically significant bleeding and adverse cardiovascular events [ Time Frame: At the end of prespecified duration of Dual Antiplatelet Therapy (DAPT) (Month 1, Month 6 or Month 12) and at Month 12 ] [ Designated as safety issue: Yes ]

Enrollment: 2125
Study Start Date: May 2013
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Drug: rivaroxaban 2.5 mg
One 2.5 mg tablet twice daily for up to twelve months
Drug: rivaroxaban 15 mg
One 15 mg tablet once daily for up to twelve months
Drug: rivaroxaban 10 mg
One 10 mg tablet once daily for up to twelve months
Drug: aspirin (ASA)
Low-dose aspirin tablet once daily for twelve months
Drug: clopidogrel
One 75 mg tablet once daily for up to twelve months
Drug: prasugrel
One 10 mg tablet once daily for up to twelve months
Drug: ticagrelor
One 90 mg tablet twice daily for up to twelve 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
Drug: aspirin (ASA)
Low-dose aspirin tablet once daily for twelve months
Drug: vitamin K antagonist (VKA)
Dose-adjusted VKA tablet (target International Normalized Ratio (INR) 2.0 to 3.0) once daily for twelve months
Drug: clopidogrel
One 75 mg tablet once daily for up to twelve months
Drug: prasugrel
One 10 mg tablet once daily for up to twelve months
Drug: ticagrelor
One 90 mg tablet twice daily for up to twelve 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
Drug: rivaroxaban 15 mg
One 15 mg tablet once daily for up to twelve months
Drug: rivaroxaban 10 mg
One 10 mg tablet once daily for up to twelve months
Drug: clopidogrel
One 75 mg tablet once daily for up to twelve months
Drug: prasugrel
One 10 mg tablet once daily for up to twelve months
Drug: ticagrelor
One 90 mg tablet twice daily for up to twelve months

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have a documented medical history of paroxysmal, persistent, or permanent non-valvular atrial fibrillation (AF)
  • Have undergone percutaneous coronary intervention (PCI) procedure (with stent placement) for primary atherosclerotic disease
  • Must have an international normalized ratio (INR) of 2.5 or below to be randomized
  • Women must be postmenopausal before entry or practicing a highly effective method of birth control when heterosexually active
  • Be willing and able to adhere to the prohibitions and restrictions specified in the study protocol

Exclusion Criteria:

  • Have any condition that contraindicates anticoagulant or antiplatelet therapy or would have an unacceptable risk of bleeding, such as, but not limited to: platelet count <90,000/microliter at screening, history of intracranial hemorrhage, 12 month history of clinically significant gastrointestinal bleeding, non-VKA induced elevated prothrombin time (PT) at screening
  • Have anemia of unknown cause with a hemoglobin level <10 g/dL (<6.21 mmol/L)
  • Have a history of stroke or Transient Ischemic Attack (TIA)
  • Have a calculated Creatinine Clearance (CrCl) <30 mL/min at screening
  • Have known significant liver disease or liver function test (LFT) abnormalities
  • Have any severe condition that would limit life expectancy to less than 12 months
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01830543

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Locations
United States, Alabama
Huntsville, Alabama, United States
United States, California
Los Alamitos, California, United States
Mission Viejo, California, United States
Oceanside, California, United States
Riverside, California, United States
Sacramento, California, United States
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Perm, Russian Federation
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Samara, Russian Federation
Saratov, Russian Federation
St. Petersburg, Russian Federation
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Tumen, Russian Federation
Tyumen, Russian Federation
South Africa
Cape Town, South Africa
Centurion, South Africa
Somerset West, South Africa
Sweden
Falun, Sweden
Göteborg, Sweden
Jönköping, Sweden
Lund, Sweden
Malmö, Sweden
Stockholm, Sweden
Stockholm N/A, Sweden
Umeå, Sweden
Örebro, Sweden
Taiwan
Kaohsiung, Taiwan
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Tainan, Taiwan
Taipei, Taiwan
Taoyuan, Taiwan
Turkey
Ankara, Turkey
Antalya, Turkey
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Gaziantep, Turkey
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Izmir, Turkey
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Sivas, Turkey
Ukraine
Cherkassy, Ukraine
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Kharkiv, Ukraine
Kharkov, Ukraine
Khemelnitskiy, Ukraine
Kyiv, Ukraine
Lviv, Ukraine
Odessa, Ukraine
Rivne, Ukraine
Uzhgorod, Ukraine
Zaporizhzhya, Ukraine
United Kingdom
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 N/A, United Kingdom
Norwich, United Kingdom
Nottingham, United Kingdom
Plymouth, United Kingdom
Portsmouth, United Kingdom
Torquay, United Kingdom
Truro, United Kingdom
Worcester, United Kingdom
Sponsors and Collaborators
Janssen Scientific Affairs, LLC
Bayer
Investigators
Study Director: Janssen Scientific Affairs, LLC Clinical Trial Janssen Scientific Affairs, LLC
  More Information

No publications provided by Janssen Scientific Affairs, LLC

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Janssen Scientific Affairs, LLC
ClinicalTrials.gov Identifier: NCT01830543     History of Changes
Other Study ID Numbers: CR100758, RIVAROXAFL3003, 2012-001491-11
Study First Received: March 19, 2013
Last Updated: August 16, 2015
Health Authority: United States: Food and Drug Administration
Germany: Ethics Commission
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Bulgaria: Bulgarian Drug Agency
Netherlands: Medicines Evaluation Board (MEB)
Russia: Ministry of Health of the Russian Federation
Romania: National Medicines Agency
Taiwan: Institutional Review Board
Australia: Human Research Ethics Committee
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Janssen Scientific Affairs, LLC:
Atrial Fibrillation
Irregular heart beat
rivaroxaban
aspirin
clopidogrel
prasugrel
ticagrelor
vitamin K antagonist

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes
Aspirin
Clopidogrel
Prasugrel
Rivaroxaban
Ticagrelor
Vitamin K
Vitamins
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Anticoagulants
Antifibrinolytic Agents
Antipyretics
Antirheumatic Agents
Cardiovascular Agents
Central Nervous System Agents
Coagulants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Fibrin Modulating Agents
Fibrinolytic Agents
Growth Substances
Hematologic Agents
Hemostatics

ClinicalTrials.gov processed this record on September 03, 2015