Statin Therapy In Cardiac Surgery (STICS)

September 16, 2014 updated by: University of Oxford
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

1922

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100037
        • Fuwai Hospital, Chinese Academy of Medical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / 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 Names:
  • Crestor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
Serial blood samples for Troponin assay will be collected at 6, 24, 48 and 120 hours after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
Outcomes will be monitored for their presence/absence (Yes/No), the post operative day of event and duration as applicable.
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
Cardiac tissue and plasma/ urine biomarkers of inflammation, oxidant stress, and cardiac function
Post operative period including day 5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oxford

Collaborators

Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Chinese Academy of Medical Sciences, Fuwai Hospital
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, Chinese Academy of Medical Sciences, Fuwai Hospital
  • Principal Investigator: Barbara Casadei, MD.DPhil.FRCP, Department of Cardiovascular Medicine, John Radcliffe Hospital, University of Oxford
  • Principal Investigator: Zheng Zhe, MD.PhD, Chinese Academy of Medical Sciences, Fuwai Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (ACTUAL)

September 1, 2014

Study Completion (ACTUAL)

September 1, 2014

Study Registration Dates

First Submitted

February 13, 2012

First Submitted That Met QC Criteria

April 4, 2012

First Posted (ESTIMATE)

April 6, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

September 17, 2014

Last Update Submitted That Met QC Criteria

September 16, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2.0 /06.09.11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Atrial Fibrillation

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Germany

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe