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

June 15, 2016 updated by: Creighton University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nebraska
      • Omaha, Nebraska, United States, 68131
        • Recruiting
        • Creighton University
        • Sub-Investigator:
          • Daniel E Hilleman, PharmD
        • Principal Investigator:
          • Aiman Smer, MBBCh
        • Sub-Investigator:
          • Manu Kaushik, MBBS
        • Sub-Investigator:
          • Janardhana Gorthi, MD
        • Sub-Investigator:
          • Hussam Abuissa, MD
        • Sub-Investigator:
          • Tammy L Burns, PharmD
        • Sub-Investigator:
          • Aryan N Mooss, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Atorvastatin 20 mg
atorvastatin 20 mg daily 2 to 7 days prior to surgery and up to 7 post surgery
Drug: Atorvastatin 20 mg
Other Names:
  • Lipitor
Experimental: Atorvastatin 80 mg
atorvastatin 80 mg daily 2 to 7 days prior to surgery and up to7 days post surgery
Drug: Atorvastatin 80 mg
Other Names:
  • Lipitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of atrial fibrillation by hospital discharge
Time Frame: 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.
Hospital discharge, an expected 5-7 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Creighton University

Investigators

  • Principal Investigator: Aiman Smer, MBBCh, Creighton University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Anticipated)

June 1, 2017

Study Completion (Anticipated)

June 1, 2017

Study Registration Dates

First Submitted

August 16, 2013

First Submitted That Met QC Criteria

January 6, 2014

First Posted (Estimate)

January 8, 2014

Study Record Updates

Last Update Posted (Estimate)

June 16, 2016

Last Update Submitted That Met QC Criteria

June 15, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-16729

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cardiothoracic Surgery

Clinical Trials on Atorvastatin 20 mg

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malta

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe