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

• Status: Completed
• Trial end date: 2016-07-28
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Scientific Affairs, LLC
• Collaborator: Bayer
• Treatments: Aspirin; Clopidogrel; Prasugrel Hydrochloride; Rivaroxaban; Ticagrelor; Ticlopidine; Vitamin K; Vitamins

Criteria

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