Statin Therapy In Cardiac Surgery (STICS)
The purpose of STICS trial (Statin Therapy In Cardiac Surgery) is to test whether perioperative treatment with Rosuvastatin 20 mg once daily prevents post-operative atrial fibrillation and reduces perioperative irreversible myocardial damage in patients undergoing elective cardiac surgery.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Statin Therapy In Cardiac Surgery|
- Post operative atrial fibrillation detected on continuous ECG monitoring. [ Time Frame: Monitoring will commence soon after surgery and will be continued until the end of post operative day 5 ] [ Designated as safety issue: No ]
- Myocardial injury assessed by Troponin release [ Time Frame: Serial blood samples for Troponin assay will be collected at 6, 24, 48 and 120 hours after surgery ] [ Designated as safety issue: No ]
- Hospital and intensive care unit stay [ Time Frame: Participants will be followed for the duration of the post operative period up to the day of initial discharge from the hospital, an expected average of 7 days. ] [ Designated as safety issue: No ]
- Major in-hospital cardiac and/or cerebrovascular events (such as death, stroke, myocardial infarction,heart failure) and acute kidney injury [ Time Frame: Participants will be followed for the duration of the post operative period up to the day of initial discharge from the hospital, an expected average of 7 days. ] [ Designated as safety issue: No ]Outcomes will be monitored for their presence/absence (Yes/No), the post operative day of event and duration as applicable.
- Cardiac tissue and plasma/ urine biomarkers [ Time Frame: Post operative period including day 5 ] [ Designated as safety issue: No ]Cardiac tissue and plasma/ urine biomarkers of inflammation, oxidant stress, and cardiac function
|Study Start Date:||September 2011|
|Estimated Study Completion Date:||October 2014|
|Estimated Primary Completion Date:||October 2014 (Final data collection date for primary outcome measure)|
Placebo Comparator: Sugar pill
Placebo started not earlier than 8 days before surgery and continued until the 5th post-operative day included.
Rosuvastatin (20 mg od)
Rosuvastatin (20 mg od) started not earlier than 8 days before surgery and continued until the 5th post-operative day included;
Other Name: Crestor
Evidence that pre- or perioperative statin treatment may reduce the occurrence of post-operative atrial fibrillation and improve clinical outcome in patients undergoing coronary artery bypass graft (CABG) or major vascular surgery has been largely generated by observational studies. In a recent meta-analysis of 6 randomized trials (of which only 2 had postoperative atrial fibrillation (AF) as a predefined outcome) evaluating the use of perioperative statin treatment in patients undergoing cardiac surgery (n=651 patients in total - study size between 40 and 200 patients), statin use was found to reduce the patients' relative risk of developing postoperative AF by 43% (RR 0.57, 95%CI 0.45,0.72) and their absolute risk by 14% (95% CI 8%,20%). Although these findings would be consistent with a rapid and, possibly, lipid-independent antiarrhythmic effect of statins, they have important limitations (e.g., single-centre, small size, lack of continuous ECG monitoring, mostly "ancillary" findings") and less bearing on current clinical practice, as they mostly included statin-naïve patients. For these reasons, the recent guidelines for the management of AF have not given a strong recommendation for the use of statins in the prevention of postoperative AF. Thus, whether intensive statin treatment in the perioperative period is associated with prevention of AF, cardio protection, and improved clinical outcome remains to be demonstrated.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01573143
|Fuwai Hospital, Chinese Academy of Medical Sciences|
|Beijing, Beijing, China, 100037|
|Study Chair:||Rory Collins, FRCP. FMed Sci||Clinical Trial Service Unit (CTSU), University of Oxford|
|Study Chair:||Shenshou Hu, MD.PhD||Fuwai Hospital, Chinese Academy of Medical Sciences|
|Principal Investigator:||Barbara Casadei, MD.DPhil.FRCP||Department of Cardiovascular Medicine, John Radcliffe Hospital, University of Oxford|
|Principal Investigator:||Zheng Zhe, MD.PhD||Fuwai Hospital, Chinese Academy of Medical Sciences|