An open-label, randomized clinical trial comparing Etacizin versus Propafenone in Atrial Fibrillation

Conditions

Atrial fibrillation

Brief summary

Recurrence of atrial fibrillation over 6 months of the treatment after restored sinus rhythm

Detailed description

Proportion of participants with pharmacological cardioversion during Phase I, The proportion of participants who meet clinical criteria for electrical cardioversion during Phase II, Time of recurrence of atrial fibrillation during Phase II, Change in Atrial fibrillation effect on quality of life from baseline to study end, Rate of hospitalizations related to atrial fibrillation during Phase II, A composite of cardiovascular death, myocardial infarction, acute coronary revascularization, and stroke (MACE), The heart rate variabilty in treatment groups

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Interventions

DRUGEtacizīns 50 mg apvalkotās tabletes

DRUGPROPAFENONE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Recurrence of atrial fibrillation over 6 months of the treatment after restored sinus rhythm	—

Secondary

Measure	Time frame
Proportion of participants with pharmacological cardioversion during Phase I, The proportion of participants who meet clinical criteria for electrical cardioversion during Phase II, Time of recurrence of atrial fibrillation during Phase II, Change in Atrial fibrillation effect on quality of life from baseline to study end, Rate of hospitalizations related to atrial fibrillation during Phase II, A composite of cardiovascular death, myocardial infarction, acute coronary revascularization, and stroke (MACE), The heart rate variabilty in treatment groups	—

Measure

Time frame

Proportion of participants with pharmacological cardioversion during Phase I, The proportion of participants who meet clinical criteria for electrical cardioversion during Phase II, Time of recurrence of atrial fibrillation during Phase II, Change in Atrial fibrillation effect on quality of life from baseline to study end, Rate of hospitalizations related to atrial fibrillation during Phase II, A composite of cardiovascular death, myocardial infarction, acute coronary revascularization, and stroke (MACE), The heart rate variabilty in treatment groups

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Countries

Latvia

Outcome results

None listed