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

Creighton University

Status and phase: Unknown; Phase 4

Conditions: Post-operative Atrial Fibrillation; Cardiothoracic Surgery

Treatments: Drug: Atorvastatin 80 mg; Drug: Atorvastatin 20 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT02029534

13-16729

Details and patient eligibility

About

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.

Full description

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

Enrollment: 200 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 2 patient groups

Atorvastatin 20 mg

Active Comparator group

Description:

atorvastatin 20 mg daily 2 to 7 days prior to surgery and up to 7 post surgery

Treatment:

Drug: Atorvastatin 20 mg

Atorvastatin 80 mg

Experimental group

Description:

atorvastatin 80 mg daily 2 to 7 days prior to surgery and up to7 days post surgery

Treatment:

Drug: Atorvastatin 80 mg