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NCT02084069 Clinical Trial

Atrovastatin for Preventing Atrial Fibrillation Following Open Cardiac Valve Repair

Heart Valve Diseases Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02084069
Other study ID # UMSU-Cardiology-2
Secondary ID
Status Completed
Phase Phase 3
First received March 8, 2014
Last updated February 13, 2015
Start date January 2013
Est. completion date April 2014

Study information
Verified date February 2015
Source Urmia University of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority Iran: Ministry of Health
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 58
Est. completion date April 2014
Est. primary completion date April 2014
Accepts healthy volunteers No
Gender Both
Age group 25 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• Atorvastatin

Locations
Country Name City State
Iran, Islamic Republic of Seyyed-al-Shohada Heart Center Urmia West-Azerbaijan

Sponsors (1)
Lead Sponsor Collaborator
Urmia University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Atrial Fibrillation Incidence After Open Cardiac Valve Repair Within 5 days after open cardiac valve repair Yes
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