Not Yet RecruitingPhase 4ACTRN12613000031763

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

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).


Sponsor

South Australian Health and Medical Research Institute

Enrollment

100 participants

Start Date

Feb 4, 2013

Study Type

Interventional

Conditions

Summary

The primary purpose of the study is to ascertain whether giving high doses of a cholesterol lowering drug (statin) can reduce the amount of damage caused to the heart by having a lack of oxygen and then having blood restored to the heart quickly when the bypass surgery is done. Tissue damage may be caused when the supply of oxygen is restored to the heart. There are sound biological reasons but limited data that shows that by giving a high dose of a statin drug it is believed that the injury to the heart may be lessened.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria2

  • 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 Criteria10

  • 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

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Interventions

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

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


Locations(2)

Flinders Medical Centre - Bedford Park

SA, Australia

The Royal Adelaide Hospital - Adelaide

SA, Australia

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ACTRN12613000031763