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).

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613000031763

Acronym

STIR (CABG)

Enrollment

100

Registered

2013-01-11

Start date

2013-02-04

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

Interventions

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

Study design

Allocation

Randomised controlled trial

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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

Outcome results