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Atrovastatin for Preventing Atrial Fibrillation Following Open Cardiac Valve Repair

Primary Purpose

Heart Valve Diseases

Status
Completed
Phase
Phase 3
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Atorvastatin
Sponsored by
Urmia University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Heart Valve Diseases

Eligibility Criteria

25 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seyyed-al-Shohada Heart Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Treatment

Control

Arm Description

Atorvastatin 40 mg once daily from 3 days before surgery up to five days after surgery

Placebo

Outcomes

Primary Outcome Measures

Atrial Fibrillation Incidence After Open Cardiac Valve Repair

Secondary Outcome Measures

Full Information

First Posted
March 8, 2014
Last Updated
February 13, 2015
Sponsor
Urmia University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02084069
Brief Title
Atrovastatin for Preventing Atrial Fibrillation Following Open Cardiac Valve Repair
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Urmia University of Medical Sciences

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Valve Diseases

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Active Comparator
Arm Description
Atorvastatin 40 mg once daily from 3 days before surgery up to five days after surgery
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Primary Outcome Measure Information:
Title
Atrial Fibrillation Incidence After Open Cardiac Valve Repair
Time Frame
Within 5 days after open cardiac valve repair

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yousef Rezaei, M.D
Organizational Affiliation
Seyyed-al-Shohada Heart Center, Urmia University of Medical Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Seyyed-al-Shohada Heart Center
City
Urmia
State/Province
West-Azerbaijan
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
25540059
Citation
Dehghani MR, Kasianzadeh M, Rezaei Y, Sepehrvand N. Atorvastatin Reduces the Incidence of Postoperative Atrial Fibrillation in Statin-Naive Patients Undergoing Isolated Heart Valve Surgery: A Double-Blind, Placebo-Controlled Randomized Trial. J Cardiovasc Pharmacol Ther. 2015 Sep;20(5):465-72. doi: 10.1177/1074248414564869. Epub 2014 Dec 24.
Results Reference
derived
Links:
URL
http://umsu.ac.ir
Description
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Atrovastatin for Preventing Atrial Fibrillation Following Open Cardiac Valve Repair

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