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
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
-
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.