Overview

This trial is active, not recruiting.

Conditions atrial fibrillation, myocardium; injury
Treatments rosuvastatin, placebo
Phase phase 4
Sponsor University of Oxford
Collaborator Cardiovascular Institute & Fuwai Hospital
Start date September 2011
End date October 2014
Trial size 1900 participants
Trial identifier NCT01573143, 2.0 /06.09.11

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention
Arm
(Placebo Comparator)
Placebo
placebo
Placebo started not earlier than 8 days before surgery and continued until the 5th post-operative day included.
(Experimental)
Rosuvastatin (20 mg od)
rosuvastatin Crestor
Rosuvastatin (20 mg od) started not earlier than 8 days before surgery and continued until the 5th post-operative day included;

Primary Outcomes

Measure
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
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

Secondary Outcomes

Measure
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.
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.
Cardiac tissue and plasma/ urine biomarkers
time frame: Post operative period including day 5

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

Inclusion Criteria: - Adult patients awaiting elective cardiac surgery who are willing and able to give informed consent for participation in the study and who are in sinus rhythm and not taking any antiarrhythmic medication, other than beta-adrenergic blocking agents, at the time of surgery. Exclusion Criteria: - History of obstructive hepato-biliary disease or other serious hepatic disease - Untreated hypothyroidism - Creatinine > 200 umol/L - Personal and family history of hereditary muscle disorders - Known intolerance to statins or history of muscle toxicity with fibrates or statins. - On-going use of fibrates, niacin or of agents that are strong inhibitors of cytochrome P-450 or the P-glycoprotein within a month preceding randomization (cyclosporine, oral azole antifungals,macrolide antibiotics, protease inhibitors, nefazodone, amiodarone or ≥ 1L/day of grapefruit juice) - Significant mitral valve disease (moderate or severe mitral regurgitation-eg. > grade II and/or mitral stenosis & mitral annular calcification). - Patients treated with any anti-arrhythmic agent (other than beta-adrenergic receptor blockers).

Additional Information

Official title Statin Therapy In Cardiac Surgery
Principal investigator Barbara Casadei, MD.DPhil.FRCP
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2014.
Information provided to ClinicalTrials.gov by University of Oxford.