Atrovastatin for Preventing Atrial Fibrillation Following Open Cardiac Valve Repair

February 13, 2015 updated by: Urmia University of Medical Sciences
The purpose of the investigation is to determine whether Atrovastatin as anti-inflammatory agent can be effective in preventing from atrial fibrillation incidence in patients whom undergone open cardiac surgery for their heart valve repair.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Greater than 25 y/o
  • No occurrence of intra- or post-operative cardiopulmonary arrest
  • Not consuming drugs affecting atrial rhythm
  • Having sinus rhythm before surgery
  • Lack of paroxysmal atrial fibrillation history
  • Only undergo heart valve surgery
  • Lack of considerable heart ischemia needed atorvastatin use
  • Routine cares in ward, post-operative ward, and intensive care unit were done

Exclusion Criteria:

  • Lesser than 25 y/o
  • History of atrial fibrillation
  • History of taking anti-arrhythmic drugs
  • History of implementing pacemakers
  • Severe heart failure
  • Renal failure
  • Hepatic failure
  • Severe pulmonary diseases
  • Heart block or bradyarrhythmia
  • Routine cares in ward, post-operative ward, and intensive care unit were not done
  • Performing concomitant cardiac surgery except valve repair
  • Having considerable heart ischemia needed atorvastatin use

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control
Placebo
Active Comparator: Treatment
Atorvastatin 40 mg once daily from 3 days before surgery up to five days after surgery
Drug: Atorvastatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Atrial Fibrillation Incidence After Open Cardiac Valve Repair
Time Frame: Within 5 days after open cardiac valve repair
Within 5 days after open cardiac valve repair

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Urmia University of Medical Sciences

Investigators

  • Study Director: Yousef Rezaei, M.D, Seyyed-al-Shohada Heart Center, Urmia University of Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

March 8, 2014

First Submitted That Met QC Criteria

March 8, 2014

First Posted (Estimate)

March 11, 2014

Study Record Updates

Last Update Posted (Estimate)

March 4, 2015

Last Update Submitted That Met QC Criteria

February 13, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UMSU-Cardiology-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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