Statin Therapy In Cardiac Surgery

NCT ID: NCT01573143

Last Updated: 2014-09-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 1922 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2014-09-30

Brief 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.

Detailed 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.

Conditions

Atrial Fibrillation; Myocardium; Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Sugar pill

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo started not earlier than 8 days before surgery and continued until the 5th post-operative day included.

Rosuvastatin

Rosuvastatin (20 mg od)

Group Type: EXPERIMENTAL

Rosuvastatin

Intervention Type: DRUG

Rosuvastatin (20 mg od) started not earlier than 8 days before surgery and continued until the 5th post-operative day included;

Interventions

Rosuvastatin

Rosuvastatin (20 mg od) started not earlier than 8 days before surgery and continued until the 5th post-operative day included;

Intervention Type: DRUG

Placebo

Placebo started not earlier than 8 days before surgery and continued until the 5th post-operative day included.

Intervention Type: DRUG

Other Intervention Names

Crestor

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese Academy of Medical Sciences, Fuwai Hospital

OTHER

Sponsor Role: collaborator

Chinese Academy of Medical Sciences

OTHER

Sponsor Role: collaborator

Peking Union Medical College

OTHER

Sponsor Role: collaborator

University of Oxford

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rory Collins, FRCP. FMed Sci

Role: STUDY_CHAIR

Clinical Trial Service Unit (CTSU), University of Oxford

Shenshou Hu, MD.PhD

Role: STUDY_CHAIR

Chinese Academy of Medical Sciences, Fuwai Hospital

Barbara Casadei, MD.DPhil.FRCP

Role: PRINCIPAL_INVESTIGATOR

Department of Cardiovascular Medicine, John Radcliffe Hospital, University of Oxford

Zheng Zhe, MD.PhD

Role: PRINCIPAL_INVESTIGATOR

Chinese Academy of Medical Sciences, Fuwai Hospital

Locations

Fuwai Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Countries

China

References

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Other Identifiers

2.0 /06.09.11

Identifier Type: -

Identifier Source: org_study_id