Statin Therapy in Ischemia-Reperfusion Injury during coronary artery bypass grafting.

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12613000031763
• Date of registration: 11/01/2013
• Prospective Registration: Yes
• Primary sponsor: South Australian Health and Medical Research Institute
• Public title: Statin Therapy in Ischemia-Reperfusion Injury during coronary artery bypass grafting.
• Scientific title: Statin therapy in Ischemia-Reperfusion Injury: A randomised trial to evaluate the effect of high dose rosuvastatin on myocardial infarct size post coronary artery bypass grafting (CABG).
• Date of first enrolment: 04/02/2013
• Target sample size: 100
• Recruitment status: Not yet recruiting
• URL: https://anzctr.org.au/ACTRN12613000031763.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);
• Phase: Phase 4

Countries of recruitment

Australia

Contacts

• Name: Ms Christine Edwards

• Name: Prof Joseph Selvanayagam

Key inclusion & exclusion criteria

Inclusion criteria: Adult patients who are scheduled to undergo elective on-pump CABG with or without aortic valve replacement.
For patients on statins pre-CABG, statin dose must be unchanged for 30 days pre-CABG.
Exclusion criteria: Standard CMR contra-indications
Known intolerance to statins
Renal (eGFR <45mls/min) and hepatic impairment
Emergency CABG
Mitral or tricuspid valve repair or replacement
Off-pump CABG
Patients who are Filipino, Chinese, Japanese, Korean or Vietnamese
Patients on cyclosporine, gemfibrozil or fisidic acid
Patients who are already on rosuvastatin or atorvastatin 80 mgs pre-CABG
Re-do surgery



Age minimum: 18 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Cardiovascular - Coronary heart disease

Post CABG ischemia reperfusion injury (IRI);
Post CABG ischemia reperfusion injury (IRI)

Surgery - Other surgery

Intervention(s)

Rosuvastatin 40mgs orally at 36 hours and 12 hours pre CABG and then rosuvastatin 40 mgs daily for 7 days post CABG.

Primary Outcome(s)

Myocardial Infarct (MI) size as assessed by CMR late gadolinium-enhancement[At Baseline (up to 30 days before CABG) and then 5-10 days post CABG surgery]

Secondary Outcome(s)

Biochemical markers of myocardial injury will be assessed by calculating the total area under the curve of the cardiac enzyme levels (CK, CKMB and Hs Troponin T) taken over an 120 hour period.[Baseline(0 Hours) pre CABG, 6, 12, 24, 48, 72 and 120 hours]

Secondary ID(s)

Nil

Source(s) of Monetary Support

South Australian Health and Medical Research Institute

Ethics review

Status: Approved
Approval date:
Contact:

Southern Adelaide Clinical Human Research Ethics Committee