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)

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 3

Conditions: Atrial Fibrillation; Percutaneous Coronary Intervention

Treatments: Drug: rivaroxaban 2.5 mg; Drug: aspirin (ASA); Drug: rivaroxaban 10 mg; Drug: ticagrelor; Drug: clopidogrel; Drug: rivaroxaban 15 mg; Drug: prasugrel; Drug: vitamin K antagonist (VKA)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01830543

RIVAROXAFL3003 (Other Identifier)

CR100758

2012-001491-11 (EudraCT Number)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 2,124 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,124 participants in 3 patient groups

rivaroxaban 2.5 mg twice daily

Experimental group

Description:

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

Treatment:

Drug: clopidogrel

Drug: ticagrelor

Drug: aspirin (ASA)

Drug: rivaroxaban 10 mg

Drug: rivaroxaban 2.5 mg

Drug: prasugrel

Drug: rivaroxaban 15 mg

vitamin K antagonist (VKA)

Experimental group

Description:

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

Treatment:

Drug: clopidogrel

Drug: ticagrelor

Drug: aspirin (ASA)

Drug: prasugrel

Drug: vitamin K antagonist (VKA)

rivaroxaban 15 mg once daily

Experimental group

Description:

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:

Drug: clopidogrel

Drug: ticagrelor

Drug: rivaroxaban 10 mg

Drug: prasugrel

Drug: rivaroxaban 15 mg