Atrovastatin for Preventing Atrial Fibrillation Following Open Cardiac Valve Repair

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2014-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Heart Valve Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Treatment

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

Group Type ACTIVE_COMPARATOR

Atorvastatin

Intervention Type DRUG

Control

Placebo

Group Type PLACEBO_COMPARATOR

No interventions assigned to this group

Interventions

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Atorvastatin

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No