Efficacy and Safety of Azimilide for the Treatment of Patients With Atrial Fibrillation

Study Overview
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Brief Summary
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Atrial fibrillation (abnormal rhythm in the upper chamber of the heart) is a common supraventricular arrhythmia (abnormal heart rhythm) for which antiarrhythmic therapy is often prescribed. The primary goals of therapy are to maintain sinus rhythm (normal heart rhythm) and to reduce the occurrence of episodes of atrial fibrillation. Azimilide may have an effect on increasing the time to first recurrence of symptomatic atrial fibrillation or atrial flutter and symptomatic paroxysmal supraventricular tachycardia (other types of abnormal heart rhythms). This double-blind, placebo-controlled study is designed to evaluate the efficacy and safety of azimilide compared with placebo in maintaining sinus rhythm in patients who require cardioversion (electric shock to correct heart rhythm) to reduce atrial fibrillation. Once this phase of the study is completed, a second phase with a different study design will be conducted. The second phase is an open-label follow-up phase to the study. This follow-up phase will continue to evaluate the long-term efficacy and safety of a daily oral dose of azimilide in patients who complete the double-blind, placebo-controlled phase of this study.

Official Title
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Efficacy and Safety of Azimilide for the Treatment of Patients With Atrial Fibrillation

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Drug: Azimilide Dihydrochloride
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Documented (12-lead ECG) history of symptomatic atrial fibrillation occurring between 48 hours and 6 months before screening Require the procedure of cardioversion (electric shock to correct heart rhythm) In the investigator's opinion, be likely to maintain sinus rhythm after cardioversion. Be anticoagulated according to the recommendations of the Study Group on Atrial Fibrillation of the European Society of Cardiology guidelines. Exclusion criteria: Previously unsuccessful electrical cardioversions Failed to respond to any Class III antiarrhythmic drugs Qualifying arrhythmia due to acute reversible illness, acute myocardial infarction, and/or cardiac or thoracic surgery within one month prior to randomization

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>placebo tablets in hospital and placebo tablets outpatient | Drug: Placebo<br>* placebo tablets once a day for 3 days in hospital and placebo tablets once a day for 6 months as outpatient<br>|
| Experimental: 2<br>Azimilide tablets in hospital and azimilide tablets outpatient | Drug: Azimilide Dihydrochloride<br>* 125 mg azimilide tablets once a day for 3 days in hospital and 125 mg azimilide tablets once a day for 6 months as outpatient<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prolong the time from start of teh efficacy period to the first symptomatic or asymptomatic event fo AFIB, etc |  | six months |