The role of high dose statins in the prevention of postoperative atrial fibrillation in patients undergoing cardiac surgery

ISRCTN ISRCTN41309956
DOI https://doi.org/10.1186/ISRCTN41309956
Secondary identifying numbers N/A
Submission date
14/08/2006
Registration date
21/09/2006
Last edited
14/12/2010
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Miss Marjan Jahangiri
Scientific

Department of Cardiac Surgery
Atkinson Morley Wing
St. George's Hospital
Blackshaw Road
London
SW17 0QT
United Kingdom

Phone +44 (0)20 8725 3565
Email marjan.jahangiri@stgeorges.nhs.uk

Study information

Study designProspective analysis, randomised, double-blind study.
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectives1. 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(s)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.
Health condition(s) or problem(s) studiedAtrial fibrillation
InterventionWe 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Atorvastatin
Primary outcome measureAtrial fibrillation
Secondary outcome measuresThromboembolic episodes (Transient Ischaemic Attacks [TIA]/CerebroVascular Accident [CVA])
Overall study start date18/09/2006
Completion date17/09/2007

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants450 patients undergoing elective first time CABG and/or AVR
Key inclusion criteriaPatients undergoing elective first time Coronary Artery Bypass Graft (CABG) and/or Aortic Valve Replacement (AVR) will be randomised.
Key exclusion criteria1. 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
Date of first enrolment18/09/2006
Date of final enrolment17/09/2007

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Department of Cardiac Surgery
London
SW17 0QT
United Kingdom

Sponsor information

St. George's Hospital Charitable Foundation (UK)
Charity

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

Website http://www.stgeorges.nhs.uk
ROR logo "ROR" https://ror.org/0001ke483

Funders

Funder type

Charity

St. George's Hospital Charitable Foundation

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/01/2011 Yes No