Atrial Fibrillation Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled Study of ATI-2042 in Patients With Paroxysmal Atrial Fibrillation and Pacemakers With Atrial Fibrillation Data Logging Capabilities
The purpose of this study is to determine the safety and efficacy of an investigational antiarrhythmic drug (ATI-2042) in the treatment of atrial fibrillation in patients with a dual chamber pacemaker.
ATI-2042 is being developed as an alternative to amiodarone, which is considered a
first-line therapy for patients with atrial fibrillation and is known to have serious side
effects. ATI-2042 was designed to have a reduced plasma half-life and a lower volume of
distribution, which is expected to result in an improved safety profile. In contrast to
amiodarone, ATI-2042 undergoes rapid metabolism via plasma and tissue esterases, which may
reduce tissue accumulation and toxicity. The current trial will determine if ATI-2042
retains the efficacy profile of amiodarone without the side effects attributable to tissue
accumulation seen with long-term dosing.
This study is an early phase trial and some specific protocol information is proprietary and
not publicly available at this time. (Full information is available to trial participants.)
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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