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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01573143
Other study ID # 2.0 /06.09.11
Secondary ID
Status Completed
Phase Phase 4
First received February 13, 2012
Last updated September 16, 2014
Start date September 2011
Est. completion date September 2014

Study information

Verified date September 2014
Source University of Oxford
Contact n/a
Is FDA regulated No
Health authority China: Ethics CommitteeChina: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


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.


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Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
China Fuwai Hospital, Chinese Academy of Medical Sciences Beijing Beijing

Sponsors (4)

Lead Sponsor Collaborator
University of Oxford Chinese Academy of Medical Sciences, Chinese Academy of Medical Sciences, Fuwai Hospital, Peking Union Medical College

Country where clinical trial is conducted

China, 

References & Publications (9)

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Outcome

Type Measure Description Time frame Safety issue
Primary Post operative atrial fibrillation detected on continuous ECG monitoring. Monitoring will commence soon after surgery and will be continued until the end of post operative day 5 No
Primary Myocardial injury assessed by Troponin release Serial blood samples for Troponin assay will be collected at 6, 24, 48 and 120 hours after surgery No
Secondary Hospital and intensive care unit stay 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. No
Secondary Major in-hospital cardiac and/or cerebrovascular events (such as death, stroke, myocardial infarction,heart failure) and acute kidney injury 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. No
Secondary Cardiac tissue and plasma/ urine biomarkers Cardiac tissue and plasma/ urine biomarkers of inflammation, oxidant stress, and cardiac function Post operative period including day 5 No
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