Efficacy and Safety Study of an Antiarrhythmic Drug to Treat Atrial Fibrillation in Patients With Pacemakers

Study Overview
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Brief Summary
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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.

Detailed Description
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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.)

Official Title
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A Randomized, Double-Blind, Placebo-Controlled Study of ATI-2042 in Patients With Paroxysmal Atrial Fibrillation and Pacemakers With Atrial Fibrillation Data Logging Capabilities

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Drug: ATI-2042
* Drug: ATI-2042 200 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Proven paroxysmal atrial fibrillation Pacemaker with appropriate AF diagnostics and recording capabilities Exclusion Criteria: Known allergy to Amiodarone or previous treatment for severe Amiodarone toxicity Cardioversion within one month of screening Severe left ventricular dysfunction or CHF with NYHA Class III or above

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: ATI-2042 200 mg<br> | Drug: ATI-2042<br>* no intervention<br>Drug: ATI-2042 200 mg<br>* To stop the dosing of ATI-2042 for a designated time frame as determined by the medical monitor and Principal Investigator.<br>|
| No Intervention: ATI-2042 400 mg<br> | Drug: ATI-2042<br>* no intervention<br>Drug: ATI-2042 200 mg<br>* To stop the dosing of ATI-2042 for a designated time frame as determined by the medical monitor and Principal Investigator.<br>|
| No Intervention: ATI-2042 600 mg<br> | Drug: ATI-2042<br>* no intervention<br>Drug: ATI-2042 200 mg<br>* To stop the dosing of ATI-2042 for a designated time frame as determined by the medical monitor and Principal Investigator.<br>|
| No Intervention: ATI-2042 Placebo<br> | Drug: ATI-2042<br>* no intervention<br>Drug: ATI-2042 200 mg<br>* To stop the dosing of ATI-2042 for a designated time frame as determined by the medical monitor and Principal Investigator.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy Measure: Atrial Fibrillation Burden |  |  | 
| Safety Measures: ECG, Laboratory and Adverse Events |  |  |