Statin Therapy In Cardiac Surgery (STICS)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Cardiovascular Institute & Fuwai Hospital
Chinese Academy of Medical Sciences
Peking Union Medical College
Information provided by (Responsible Party):
University of Oxford
ClinicalTrials.gov Identifier:
NCT01573143
First received: February 13, 2012
Last updated: February 26, 2014
Last verified: October 2013

February 13, 2012
February 26, 2014
September 2011
October 2014   (final data collection date for primary outcome 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 ] [ 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 ]
Same as current
Complete list of historical versions of study NCT01573143 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Statin Therapy In Cardiac Surgery
Statin Therapy In Cardiac Surgery

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Atrial Fibrillation
  • Myocardium; Injury
  • Drug: Rosuvastatin
    Rosuvastatin (20 mg od) started not earlier than 8 days before surgery and continued until the 5th post-operative day included;
    Other Name: Crestor
  • Drug: Placebo
    Placebo started not earlier than 8 days before surgery and continued until the 5th post-operative day included.
  • Placebo Comparator: Sugar pill
    Placebo
    Intervention: Drug: Placebo
  • Experimental: Rosuvastatin
    Rosuvastatin (20 mg od)
    Intervention: Drug: Rosuvastatin

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1900
October 2014
October 2014   (final data collection date for primary outcome measure)

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).
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01573143
2.0 /06.09.11
Yes
University of Oxford
University of Oxford
  • Cardiovascular Institute & Fuwai Hospital
  • Chinese Academy of Medical Sciences
  • Peking Union Medical College
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
University of Oxford
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP