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Atrovastatin for Preventing Atrial Fibrillation Following Open Cardiac Valve Repair

U

Urmia University of Medical Sciences

Status and phase

Completed
Phase 3

Conditions

Heart Valve Diseases

Treatments

Drug: Atorvastatin

Study type

Interventional

Funder types

Other

Identifiers

NCT02084069
UMSU-Cardiology-2

Details and patient eligibility

About

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.

Enrollment

58 patients

Sex

All

Ages

25+ years old

Volunteers

No 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

58 participants in 2 patient groups, including a placebo group

Treatment
Active Comparator group
Description:
Atorvastatin 40 mg once daily from 3 days before surgery up to five days after surgery
Treatment:
Drug: Atorvastatin
Control
Placebo Comparator group
Description:
Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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