Intensive Statin Therapy Effect on Post-Operative Atrial Fibrillation (POAF)

Cardiothoracic Surgery Clinical Trial

Official title:

Intensive Statin Therapy Effect on Incidence of Post-Operative Atrial Fibrillation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02029534
• Other study ID #: 13-16729
• Status: Recruiting
• Phase: Phase 4
• First received: August 16, 2013
• Last updated: June 15, 2016
• Start date: August 2013
• Est. completion date: June 2017

Study information

• Verified date: June 2016
• Source: Creighton University
• Contact: Caroline Nubel
• Phone: 402-280-4032
• Email: carolinenubel[@]creighton.edu
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This study will compare the effects of 20 mg of atorvastatin to 80 mg of atorvastatin for the prevention of atrial fibrillation after cardiothoracic surgery. The study hypothesis is that 80 mg of atorvastatin will be more effective at preventing atrial fibrillation compared to 20 mg.

Description:

This is a randomized, double-blind comparison of two doses of atorvastatin for prevention of post-operative atrial fibrillation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Age 19 or older

• Undergoing elective cardiothoracic surgery

Exclusion Criteria:

• Emergency cardiothoracic surgery

• History of permanent atrial fibrillation

• Acute coronary syndrome within 7 days

• Antiarrhythmic drug use in the past 3 months

• Receiving maximal tolerated dose of statin therapy

• Receiving fibrate therapy

• History of statin intolerance

• Significant liver impairment (aspartate aminotransferase/alanine aminotransferase(AST/ALT)>2x ULN)

• Serum Creatinine > 3 mg/dl

• Pregnancy or breastfeeding

Study Design

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Cardiothoracic Surgery
• Post-operative Atrial Fibrillation

Intervention

Drug:
• Atorvastatin 20 mg

• Atorvastatin 80 mg

Locations

Country	Name	City	State
United States	Creighton University	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
Creighton University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of atrial fibrillation by hospital discharge	Occurrence of atrial fibrillation, defined as a new diagnosis of atrial fibrillation that lasts at least 5 minutes based on telemetry or 12 lead ECG readings.	Hospital discharge, an expected 5-7 days	No
Secondary	Length of hospital stay		Hospital discharge, an expected 5-7 days	No
Secondary	Incidence of major adverse cardiac and cardiovascular events (MACCE) at 30 days		30 days	No