Status:
COMPLETED
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
Lead Sponsor:
Janssen Scientific Affairs, LLC
Collaborating Sponsors:
Bayer
Conditions:
Atrial Fibrillation
Percutaneous Coronary Intervention
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 dua...
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 s...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 10 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 28 2016
Estimated Enrollment :
2124 Patients enrolled
Trial Details
Trial ID
NCT01830543
Start Date
May 10 2013
End Date
July 28 2016
Last Update
September 19 2017
Active Locations (348)
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1
Huntsville, Alabama, United States
2
Los Alamitos, California, United States
3
Mission Viejo, California, United States
4
Oceanside, California, United States