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

Phase 4

• Conditions: Cardiothoracic Surgery; Post-operative Atrial Fibrillation
• Interventions: Drug: Atorvastatin 80 mg; Drug: Atorvastatin 20 mg

• Registration Number: NCT02029534
• Lead Sponsor: Creighton University

Brief 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.

Detailed Description

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

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-08-16
• Study First Submitted QC: 2014-01-06
• Study First Posted: 2014-01-08
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-15
• Last Update Posted: 2016-06-16
• Primary Completion: 2017-06
• Study Completion: 2017-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Atorvastatin 80 mg	Atorvastatin 80 mg	atorvastatin 80 mg daily 2 to 7 days prior to surgery and up to7 days post surgery
Atorvastatin 20 mg	Atorvastatin 20 mg	atorvastatin 20 mg daily 2 to 7 days prior to surgery and up to 7 post surgery

Primary Outcome Measures

Name	Time	Method
Occurrence of atrial fibrillation by hospital discharge	Hospital discharge, an expected 5-7 days	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.

Secondary Outcome Measures

Name	Time	Method
Length of hospital stay	Hospital discharge, an expected 5-7 days
Incidence of major adverse cardiac and cardiovascular events (MACCE) at 30 days	30 days

Trial Locations

Locations (1)

Creighton University; 🇺🇸 Omaha, Nebraska, United States