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

Completed · Phase 3

Conditions studied: Atrial Fibrillation, Percutaneous Coronary Intervention

In brief

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).

Key facts

Study ID

NCT01830543

Run by

Janssen Scientific Affairs, LLC

People needed

2124

Starts

2013-05-10

Expected to finish

2016-07-28

Last updated by the study team

2017-09-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Los Alamitos, California, United States
• Study site — Mission Viejo, California, United States
• Study site — Oceanside, California, United States
• Study site — Riverside, California, United States
• Study site — Sacramento, California, United States
• Study site — San Francisco, California, United States
• Study site — Stockton, California, United States
• Study site — Thousand Oaks, California, United States
• Study site — Torrance, California, United States
• Study site — Colorado Springs, Colorado, United States
• Study site — Lakewood, Colorado, United States
• Study site — Littleton, Colorado, United States
• Study site — Danbury, Connecticut, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Atlantis, Florida, United States
• Study site — Clearwater, Florida, United States
• Study site — Daytona Beach, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Port Charlotte, Florida, United States
• Study site — Safety Harbor, Florida, United States
• Study site — St. Petersburg, Florida, United States
• Study site — Tallahassee, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Columbus, Georgia, United States
• Study site — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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