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Statin Therapy In Cardiac Surgery (STICS)

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ClinicalTrials.gov Identifier: NCT01573143
Recruitment Status : Completed
First Posted : April 6, 2012
Last Update Posted : September 17, 2014
Sponsor:
Collaborators:
Chinese Academy of Medical Sciences, Fuwai Hospital
Chinese Academy of Medical Sciences
Peking Union Medical College
Information provided by (Responsible Party):
University of Oxford

Study Description
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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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Myocardium; Injury Drug: Rosuvastatin Drug: Placebo Phase 4

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1922 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Statin Therapy In Cardiac Surgery
Study Start Date : September 2011
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
  2. 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 Outcome Measures :
  1. 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. ]
  2. 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. ]
    Outcomes will be monitored for their presence/absence (Yes/No), the post operative day of event and duration as applicable.

  3. Cardiac tissue and plasma/ urine biomarkers [ Time Frame: Post operative period including day 5 ]
    Cardiac tissue and plasma/ urine biomarkers of inflammation, oxidant stress, and cardiac function


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01573143


Locations
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China, Beijing
Fuwai Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing, China, 100037
Sponsors and Collaborators
University of Oxford
Chinese Academy of Medical Sciences, Fuwai Hospital
Chinese Academy of Medical Sciences
Peking Union Medical College
Investigators
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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
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT01573143    
Other Study ID Numbers: 2.0 /06.09.11
First Posted: April 6, 2012    Key Record Dates
Last Update Posted: September 17, 2014
Last Verified: September 2014
Keywords provided by University of Oxford:
Surgical Procedures, Cardiac
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Rosuvastatin
Post operative atrial fibrillation
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Rosuvastatin Calcium
Anticholesteremic Agents
 Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors