CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 60 enrolled
Drug / intervention
Intravenous amiodarone(1) +1 moredrug
Likely dose
Intravenous amiodarone(1) 5 mg/Kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03432663
NCT03432663Phase 4Completed

Using Time-dependent Intravenous Infusions of Amiodarone for Conversions to Sinus Rhythms in Patients With Paroxysmal Atrial Fibrillation

Instituto de Cardiología y Medicina Vascular Hospital Zambrano-Hellion Tec Salud·interventional·Posted Feb 14, 2018·Updated Feb 14, 2018

In Brief

A Phase 4 clinical trial evaluating Intravenous amiodarone(1) and Intravenous amiodarone(2) for Atrial Fibrillation. Completed, enrolled 60 participants across 1 site.

Detailed Summary

Sixty consecutive emergency patients with newly diagnosed Atrial Fibrillation were randomized into two groups. The first received intravenous amiodarone infusions continuously for 24 hours; the second received Amiodarone until sinus rhythms was reached or for up to 72 hours. The efficacy and safety of administering intravenous infusions of amiodarone for up to 72 hours were investigated and compared to the efficacy and safety of administering a standard 24 hours infusion of amiodarone. Specifically, the use of up to 72 hours infusions was considered as a new strategy to improve rates of conversion to sinus rhythm without altering the safety profile of the drug.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesMexico
Collaborators--

Timeline

Phase 4CompletedFinished
2009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 14, 2018
Enrollment StartAug 1, 2008
Primary CompletionNov 30, 2009
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 8.4 years ago

Interventions

Intravenous amiodarone(1)drug

Intravenous amiodarone infusions at doses of 5 mg/Kg for over 30 min, followed by 20 mg/Kg until 24 h was reached

Intravenous amiodarone(2)drug

Intravenous amiodarone infusions at doses of 5 mg/Kg for over 30 min, followed by 20 mg/Kg every 24 h for up to 72 h or until sinus rhythm was reached