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Treatment of Postoperative Atrial Fibrillation - Comparison of Amiodarone and Placebo.

NCT02715687 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2016-03-22

No results posted yet for this study

Summary

Post-operative atrial fibrillation (POAF) is the most common complication encountered after cardiac surgery; reports show POAF to occur in \~ 35% of patients after CABG. Prophylactic use amiodarone was found to be effective, however, due to serious extracardiac adverse effects therapy is probably appropriate just for patients at high risk for POAF.

the common practice for management of POAF is treatment with intravenous Amiodarone until return to sinus rhythm, following which the drug is given orally. Our protocol involves continued treatment with amiodarone for 30 day post-discharge from the hospital in a dose of 200mg per day.

This protocol is a common practice in many cardiac surgical departments worldwide, nevertheless, it is not evidence-based protocol and it was never examined as such.

This study is a randomized placebo controlled trial, to evaluate the requirement for post-discharge treatment with oral Amiodarone.

Conditions

Interventions

DRUG

Amiodarone

Will receive 30 days treatment with oral amniodarone of 200mg

DRUG

Placebo

Will receive 30 days treatment with oral placebo of 200mg

Sponsors & Collaborators

  • Rambam Health Care Campus

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2017-12-31
Completion
2018-12-31

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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 NCT02715687 on ClinicalTrials.gov