NCT00611143

Brief Summary

The purpose of this study is to determine whether pretreatment with atorvastatin protects against atrial fibrillation following off-pump coronary artery bypass graft surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 27, 2008

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 8, 2008

Completed
Last Updated

February 8, 2008

Status Verified

January 1, 2008

Enrollment Period

11 months

First QC Date

January 27, 2008

Last Update Submit

January 27, 2008

Conditions

Coronary Artery Bypass

Keywords

Off-pump coronary artery bypass graftAtorvastatinPostoperative atrial fibrillation

Outcome Measures

Primary Outcomes (1)

  • the development of postoperative in-hospital atrial fibrillation confirmed by 12-lead ECG

    in-hospital period

Secondary Outcomes (1)

  • major adverse cardiac and cerebrovascular events rate, including cardiovascular death, postoperative stroke, myocardial infarction, or persistent atrial fibrillation,and identification of predictive markers for postoperative atrial fibrillation

    30 days

Study Arms (2)

1

EXPERIMENTAL

Atorvastatin group

Drug: atorvastatin

2

NO INTERVENTION

Control group

Interventions

atorvastatinDRUG

atorvastatin 20 mg/d, started 3 days before surgery

1

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • consecutive patients scheduled for the elective off-pump CABG surgery

You may not qualify if:

  • prior statin use
  • previous episodes of atrial fibrillation
  • impaired renal function with serum creatinine \>2mg/dL
  • serum aspartate aminotransferase or alanine aminotransferase concentrations more than 3 times the upper limit of normal
  • a malignancy or inflammatory disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiac and Vascular Center; Samsung Medical Center

Seoul, 135-710, South Korea

Location

Related Publications (1)

  • Song YB, On YK, Kim JH, Shin DH, Kim JS, Sung J, Lee SH, Kim WS, Lee YT. The effects of atorvastatin on the occurrence of postoperative atrial fibrillation after off-pump coronary artery bypass grafting surgery. Am Heart J. 2008 Aug;156(2):373.e9-16. doi: 10.1016/j.ahj.2008.04.020. Epub 2008 Jun 17.

    PMID: 18657672DERIVED

MeSH Terms

Interventions

Atorvastatin

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Study Officials

  • Young Keun On, MD, PhD

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 27, 2008

First Posted

February 8, 2008

Study Start

May 1, 2006

Primary Completion

April 1, 2007

Study Completion

May 1, 2007

Last Updated

February 8, 2008

Record last verified: 2008-01

Locations

KR(1)