| Source of record | UK Trials |
| ISRCTN | ISRCTN41309956 |
| Date ISRCTN assigned | 21/09/2006 |
| Local reference number(s) | N/A |
| Public title | The role of high dose statins in the prevention of postoperative atrial fibrillation in patients undergoing cardiac surgery |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Atrial fibrillation |
| 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. |
| Design/methodology | Prospective analysis, randomised, double-blind study. |
| Research ethics review | 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. |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | Patients undergoing elective first time Coronary Artery Bypass Graft (CABG) and/or Aortic Valve Replacement (AVR) will be randomised. |
| Participants - 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 |
| Patient information material |
|
| Anticipated start date | 18/09/2006 |
| Anticipated end date | 17/09/2007 |
| Status of trial | Completed |
| Target number of participants | 450 patients undergoing elective first time CABG and/or AVR |
| Interventions | 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. |
| Primary outcome measure(s) | Atrial fibrillation |
| Secondary outcome measure(s) | Thromboembolic episodes (Transient Ischaemic Attacks [TIA]/CerebroVascular Accident [CVA]) |
| Sources of funding | St. George's Hospital Charitable Foundation |
| Sponsor name | St. George's Hospital Charitable Foundation (UK) |
| Sponsor details | Bronte House
St. George's Hospital
Blackshaw Road
London
United Kingdom
SW17 0QT |
| Sponsor website | http://www.stgeorges.nhs.uk |
| Contact name | Miss Marjan Jahangiri |
| Contact details | Department of Cardiac Surgery
Atkinson Morley Wing
St. George's Hospital
Blackshaw Road
London
United Kingdom
SW17 0QT |
| Contact telephone | +44 (0)20 8725 3565 |
| Contact fax | +44 (0)20 8725 2049 |
| Contact email | marjan.jahangiri@stgeorges.nhs.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN41309956 |
| Date last extracted from ISRCTN register | 17/04/2008 |
