WithdrawnPhase 4ACTRN12613000032752

Statin Therapy in Ischemia-Reperfusion Injury sustained during a heart attack

Statin Therapy in Ischemia-Reperfusion Injury: A randomised trial to evaluate the effect of high dose rosuvastatin on myocardial infarct size post ST elevation myocardial infarction (STEMI).


Sponsor

SAHMRI

Enrollment

300 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 blocked artery is opened by the insertion of a stent. 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 and that incidences of heart failure caused by the heart attack may be lessened.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 80 Yearss

Inclusion Criteria2

  • Symptoms of acute myocardial infarction within 12 hours with ST elevation of more than 1 mm in at least two contigous leads on ECG of new onset Left Bundle Branch Block.
  • Provision of written informed consent.

Exclusion Criteria10

  • Cardiogenic shock or symptomatic hypotension or sitting SBP < 95 mm Hg
  • Previous MI
  • Standard CMR contraindications (e.g. pacemaker, severe claustrophobia etc.)
  • Known serious or hypersensitivity reactions to statin
  • known familial hypercholesterolemia
  • known active liver disease or significant renal failure (eGFR < 45 mls/min)
  • Non-cardiac comorbidity with life expectation < 1 year.
  • Patients who are Filipino, Chinese, Japanese, Korean or Vietnamese.
  • Patients taking any of the following cyclosporine, gemfibrozel or fusidic acid.
  • Attending consultant intends to use high dose statin therapy, Atorvastatin 80 mgs or Rosuvastatin 40 mgs.

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Interventions

Rosuvastatin 40 mgs orally on randomisation and daily for 5 days post angioplasty. Angioplasty is performed as soon as possible post randomisation.

Rosuvastatin 40 mgs orally on randomisation and daily for 5 days post angioplasty. Angioplasty is performed as soon as possible post randomisation.


Locations(5)

Flinders Medical Centre - Bedford Park

NSW,SA, Australia

The Royal Adelaide Hospital - Adelaide

NSW,SA, Australia

Lyell McEwin Hospital - Elizabeth Vale

NSW,SA, Australia

Royal North Shore Hospital - St Leonards

NSW,SA, Australia

Liverpool Hospital - Liverpool

NSW,SA, Australia

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ACTRN12613000032752