Condition category
Circulatory System
Date applied
14/08/2006
Date assigned
21/09/2006
Last edited
14/12/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Miss Marjan Jahangiri

ORCID ID

Contact details

Department of Cardiac Surgery
Atkinson Morley Wing
St. George's Hospital
Blackshaw Road
London
SW17 0QT
United Kingdom
+44 (0)20 8725 3565
marjan.jahangiri@stgeorges.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

1. Perioperative treatment with high dose atorvastatin (80 mg once daily) reduces the occurrence of Atrial Fibrillation (AF) following cardiac surgery in the early postoperative period.
2. Perioperative treatment with atorvastatin prevents irreversible perioperative myocardial injury.
3. Metabolic derangements may explain the increased energy demand during AF.

Ethics approval

Ethical approval has been obtained for this study from the Wandsworth Local Research Ethics Committee (reference number: 06/Q0803/37). The study has been registered with the Clinical Trials Unit.

Study design

Prospective analysis, randomised, double-blind study.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Atrial fibrillation

Intervention

We propose to carry out a randomised, double-blind study of the effect of atorvastatin 80 mg, or placebo on postoperative AF in 450 patients undergoing cardiac surgery. Patients of all ages will be included and those in sinus rhythm will be chosen. Inflammatory markers including C-Reactive Protein (CRP), Matrix MetalloProteinase (MMP) and its inhibitor, will be measured. Both right and, where possible, left atrial tissue will be studied for proteomic analysis. AF will be documented by continuous monitoring in the postoperative period.

The patients will be randomised to the following groups:
1. Patients on statins will be randomised to 10 mg and 80 mg of atorvastatin
2. Patients taking no statins will be randomised to placebo and 80 mg of atorvastatin

The treatments will continue for one week following surgery. Patients will be evaluated in an assessment clinic one week prior to surgery and will be randomised to one of the two groups. If patients have already been on any of the statins, that will be stopped in the clinic. Randomisation will be performed by the Clinical Trials Unit using a minimisation algorithm. All patients will have a trans-thoracic echocardiography performed prior to surgery determining the size of the atria, right and left ventricular function and evidence of thrombo-embolism.

Intervention type

Drug

Phase

Not Specified

Drug names

Atorvastatin

Primary outcome measures

Atrial fibrillation

Secondary outcome measures

Thromboembolic episodes (Transient Ischaemic Attacks [TIA]/CerebroVascular Accident [CVA])

Overall trial start date

18/09/2006

Overall trial end date

17/09/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Patients undergoing elective first time Coronary Artery Bypass Graft (CABG) and/or Aortic Valve Replacement (AVR) will be randomised.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

450 patients undergoing elective first time CABG and/or AVR

Participant exclusion criteria

1. History of atrial arrhythmias
2. Hepatobiliary disease
3. Creatinine more than 180 mmol/l
4. Known intolerance of statins
5. Patients on long-term inhibitors of cytochrome P-450, history of AF, patients on treatment for anti-arrhythmic agents, except those on betablockers

Recruitment start date

18/09/2006

Recruitment end date

17/09/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Cardiac Surgery
London
SW17 0QT
United Kingdom

Sponsor information

Organisation

St. George's Hospital Charitable Foundation (UK)

Sponsor details

Bronte House
St. George's Hospital
Blackshaw Road
London
SW17 0QT
United Kingdom

Sponsor type

Charity

Website

http://www.stgeorges.nhs.uk

Funders

Funder type

Charity

Funder name

St. George's Hospital Charitable Foundation

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20624624

Publication citations

  1. Results

    Kourliouros A, Valencia O, Hosseini MT, Mayr M, Sarsam M, Camm J, Jahangiri M, Preoperative high-dose atorvastatin for prevention of atrial fibrillation after cardiac surgery: a randomized controlled trial., J. Thorac. Cardiovasc. Surg., 2011, 141, 1, 244-248, doi: 10.1016/j.jtcvs.2010.06.006.

Additional files

Editorial Notes