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

Primary Purpose

Cardiothoracic Surgery, Post-operative Atrial Fibrillation

Status

Unknown status

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Atorvastatin 20 mg

Atorvastatin 80 mg

About this trial

This is an interventional prevention trial for Cardiothoracic Surgery focused on measuring post-operative atrial fibrillation, POAF, A-Fib

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Creighton UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Atorvastatin 20 mg

Atorvastatin 80 mg

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Length of hospital stay

Incidence of major adverse cardiac and cardiovascular events (MACCE) at 30 days

Full Information

NCT ID

NCT02029534

First Posted

August 16, 2013

Last Updated

June 15, 2016

Sponsor

Creighton University

1. Study Identification

Unique Protocol Identification Number

NCT02029534

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2016

Overall Recruitment Status

Unknown status

Study Start Date

August 2013 (undefined)

Primary Completion Date

June 2017 (Anticipated)

Study Completion Date

June 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Creighton University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cardiothoracic Surgery, Post-operative Atrial Fibrillation

Keywords

post-operative atrial fibrillation, POAF, A-Fib

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Atorvastatin 20 mg

Arm Type

Active Comparator

Arm Description

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

Arm Title

Atorvastatin 80 mg

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Atorvastatin 20 mg

Other Intervention Name(s)

Lipitor

Intervention Type

Drug

Intervention Name(s)

Atorvastatin 80 mg

Other Intervention Name(s)

Lipitor

Primary Outcome Measure Information:

Title

Occurrence of atrial fibrillation by hospital discharge

Description

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.

Time Frame

Hospital discharge, an expected 5-7 days

Secondary Outcome Measure Information:

Title

Length of hospital stay

Time Frame

Hospital discharge, an expected 5-7 days

Title

Incidence of major adverse cardiac and cardiovascular events (MACCE) at 30 days

Time Frame

30 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Caroline Nubel

Phone

402-280-4032

carolinenubel@creighton.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Aiman Smer, MBBCh

Organizational Affiliation

Creighton University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Creighton University

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68131

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Aiman Smer, MBBCh

First Name & Middle Initial & Last Name & Degree

Manu Kaushik, MBBS

First Name & Middle Initial & Last Name & Degree

Janardhana Gorthi, MD

First Name & Middle Initial & Last Name & Degree

Daniel E Hilleman, PharmD

First Name & Middle Initial & Last Name & Degree

Hussam Abuissa, MD

First Name & Middle Initial & Last Name & Degree

Tammy L Burns, PharmD

First Name & Middle Initial & Last Name & Degree

Aryan N Mooss, MD

12. IPD Sharing Statement

Learn more about this trial

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

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