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Time-dependent Amiodarone Treatment in Atrial Fibrillation

NCT03432663 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2018-02-14

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Intravenous amiodarone(1)

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

DRUG

Intravenous amiodarone(2)

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

Sponsors & Collaborators

  • Instituto de Cardiología y Medicina Vascular Hospital Zambrano-Hellion Tec Salud

    lead OTHER

Principal Investigators

  • Luis A Sanchez-Trujillo, MD · Escuela de Medicina y Ciencias de la Salud. Tecnológico de Monterrey. Monterrey. México

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-08-01
Primary Completion
2009-11-30
Completion
2009-11-30

Countries

  • Mexico

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03432663 on ClinicalTrials.gov