NCT01830543

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,124 (actual)
• Sponsor: Janssen Scientific Affairs, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

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.

Conditions

• Atrial Fibrillation
• Percutaneous Coronary Intervention

Interventions

Type	Name	Description
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	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

Timeline

• Start date: 2013-05-10
• Primary completion: 2016-07-28
• Completion: 2016-07-28
• First posted: 2013-04-12
• Last updated: 2017-09-19
• Results posted: 2017-07-31

Locations

348 sites across 25 countries: United States, Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, Czechia, Denmark, France, Germany, Malaysia, Mexico, Netherlands, Poland, Romania, Russia, South Africa, South Korea, Sweden, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom