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 |
| Protocol serial number | N/A |
| Sponsor | St. George's Hospital Charitable Foundation (UK) |
| Funder | St. George's Hospital Charitable Foundation |
- 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
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 |
|---|---|
| marjan.jahangiri@stgeorges.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Prospective analysis, randomised, double-blind study. |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | 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(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) studied | 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 / device / biological / vaccine name(s) | Atorvastatin |
| Primary outcome measure(s) |
Atrial fibrillation |
| Key secondary outcome measure(s) |
Thromboembolic episodes (Transient Ischaemic Attacks [TIA]/CerebroVascular Accident [CVA]) |
| Completion date | 17/09/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 450 |
| Key inclusion criteria | Patients undergoing elective first time Coronary Artery Bypass Graft (CABG) and/or Aortic Valve Replacement (AVR) will be randomised. |
| Key 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 |
| Date of first enrolment | 18/09/2006 |
| Date of final enrolment | 17/09/2007 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Department of Cardiac Surgery
London
SW17 0QT
United Kingdom
SW17 0QT
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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 |
