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

Janssen Scientific Affairs, LLC2,124 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

2,124

Conditions

Atrial Fibrillation Percutaneous Coronary Intervention

Interventions

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: Up to Month 12

Secondary Outcomes

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).