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
  Purpose

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.


Condition Intervention Phase
Atrial Fibrillation
Myocardium; Injury
Drug: Rosuvastatin
Drug: Placebo
Phase 4

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University of Oxford:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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


Estimated Enrollment: 1900
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)
Arms Assigned Interventions
Placebo Comparator: Sugar pill
Placebo
Drug: Placebo
Placebo started not earlier than 8 days before surgery and continued until the 5th post-operative day included.
Experimental: Rosuvastatin
Rosuvastatin (20 mg od)
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01573143

Locations
China, Beijing
Fuwai Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing, China, 100037
Sponsors and Collaborators
University of Oxford
Cardiovascular Institute & Fuwai Hospital
Chinese Academy of Medical Sciences
Peking Union Medical College
Investigators
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
  More Information

Publications:

Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT01573143     History of Changes
Other Study ID Numbers: 2.0 /06.09.11
Study First Received: February 13, 2012
Last Updated: February 26, 2014
Health Authority: China: Ethics Committee
China: Food and Drug Administration

Keywords provided by University of Oxford:
Surgical Procedures, Cardiac
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Rosuvastatin
Post operative atrial fibrillation

Additional relevant MeSH terms:
Atrial Fibrillation
Wounds and Injuries
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Rosuvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 26, 2014