Recruiting

Intensive Statin Therapy

Sponsor:

Creighton University

Code:

NCT02029534

Conditions

Cardiothoracic Surgery

Post-operative Atrial Fibrillation

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Interventions

Atorvastatin 20 mg

Atorvastatin 80 mg

Study Details

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.

Conditions

Cardiothoracic Surgery

Post-operative Atrial Fibrillation

Study ID

NCT02029534

Start date

Aug, 2013

Status verified date

Jun, 2016

Completion date

Jun, 2017

Anticipated

Primary completion date

Jun, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

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

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Atorvastatin 20 mg

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

experimental: Atorvastatin 80 mg

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

Interventions

Atorvastatin 20 mg

Atorvastatin 80 mg

Primary outcome measure

  • Occurrence of atrial fibrillation by hospital discharge [ Time Frame: Hospital discharge, an expected 5-7 days ]

Central Contacts and Locations

Central contacts

Caroline Nubel

402-280-4032carolinenubel@creighton.edu

Locations

Creighton University

Recruiting

Omaha, Nebraska, United States, 68131

Principal Investigator:

Aiman Smer, MBBCh

More Information

Sponsor

Creighton University

Last update posted

Jun 16, 2016

Last verified

Jun, 2016

Keywords

  • post-operative atrial fibrillation
  • POAF
  • A-Fib

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Creighton University on 2016-06-16.