Safety and Efficacy of Oral Versus Intravenous Amiodarone in the Treatment of AF

NCT01817439 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2013-03-25

No results posted yet for this study

Summary

Atrial fibrillation (AF) remains a significant contributor to cardiovascular morbidity. Amiodarone is a potent antiarrhythmic drug; however, patients receiving IV amiodarone are at high risk for phlebitis. Phlebitis may lead to infection, additional medical intervention, delay in treatment, and prolonged hospitalization. Therefore, examining new therapy approach, aimed to reduce the incidence of phlebitis is a valuable clinical and research goal.

Aim: To evaluate the safety and efficacy of oral versus intravenous (IV) Amiodarone in the treatment of AF of recent onset (duration \< 48 h).

Conditions

Interventions

DRUG

Amiodarone

patients will be randomly assigned to oral OR IV Amiodarone

Sponsors & Collaborators

  • Western Galilee Hospital-Nahariya

    lead OTHER_GOV

Principal Investigators

  • Atar Shaul, MD · Western Galilee Hospital

  • Nicola Makhoul, MD · Western Galilee Hospital

  • Lilach Shema-didi, PhD · Western Galilee Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2015-05-31
Completion
2015-05-31

Countries

  • Israel

Study Locations

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Entities

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 NCT01817439 on ClinicalTrials.gov