Phase 3
N=58
Atrovastatin for Preventing Atrial Fibrillation Following Open Cardiac Valve Repair
Heart Valve Diseases
Bottom Line
View on ClinicalTrials.gov: NCT02084069 ↗Enrolled (actual)
58
Serious AEs
5.2%
Results posted
Feb 2015
Primary outcome: Primary: Atrial Fibrillation Incidence After Open Cardiac Valve Repair — 6; 13 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Atorvastatin (Drug)
- Age
- Adult, Older Adult · 25+ yrs
- Sex
- All
- Sponsor
- Urmia University of Medical Sciences
- Primary completion
- Apr 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Atrial Fibrillation Incidence After Open Cardiac Valve Repair |
6; 13 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02084069). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.