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Pharmacological

Pioneer: An open-label, randomized, controlled, multicenter study exploring two treatment stratefies of Rivaroxaban and dose-adjusted oral vitamin K antagonist treatment strategy in subjects with Atrial Fibrillation who undergo percutaneous coronary intervention.

Short Description: There are no clear guidelines to determine the dosing strategy for instituting an anticoagulant therapy in addition to standard dual antiplatelet therapy and its duration in patients with AF. This is an open-label, randomized, multicenter clinical study assessing the safety of 2 rivaroxaban treatment strategies and one VKA treatment strategy in men and women, 18 years of age and older, who have paroxysmal, persistent, or permanent non-valvular AF and have had a PCI with stent placement.
A target of 2,100 subjects will be randomized into the study, with approximately 700 subjects in each treatment strategy group. The randomization will be stratified by the intended duration of DAPT (1, 6, or 12 months). Eligible subjects will be randomly assigned in a 1:1:1 ratio to 1 of 3 treatment strategy
groups. Subjects will be followed for approximately 12 months. Please contact Kate Dalton, MS, RD, CCRC at keb2114@columbia.edu if you have questions or would like to refer a patient.

Principal Investigator: Jeffrey W. Moses, MD

http://clinicaltrials.gov/ct2/show/NCT01830543?term=pioneer+afib+pci&rank=1

 

 

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