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
NCT01830543 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2124
Last updated 2017-09-19
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).
Conditions
- Atrial Fibrillation
- Percutaneous Coronary Intervention
Interventions
- 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
Sponsors & Collaborators
- collaborator INDUSTRY
-
Janssen Scientific Affairs, LLC
lead INDUSTRY
Principal Investigators
-
Janssen Scientific Affairs, LLC Clinical Trial · Janssen Scientific Affairs, LLC
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-05-10
- Primary Completion
- 2016-07-28
- Completion
- 2016-07-28
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
Study Locations
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