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

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Sugar pill
Placebo
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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 |
- 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 ]
- 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 ]
- 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. ]
- 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.
- 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

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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 |
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).

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
China, Beijing | |
Fuwai Hospital, Chinese Academy of Medical Sciences | |
Beijing, Beijing, China, 100037 |
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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 |
Surgical Procedures, Cardiac Hydroxymethylglutaryl-CoA Reductase Inhibitors Rosuvastatin Post operative atrial fibrillation |
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 |