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

Phase 4

Withdrawn

• Conditions: Cardiovascular - Coronary heart disease; Acute ST Elevation Myocardial Infarction

• Registration Number: ACTRN12613000032752
• Lead Sponsor: SAHMRI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-01-11
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Withdrawn
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

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 Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Myocardial Infarction (MI) size will be assessed by Cardiac Magnetic Resonance (CMR) late gadolinium enhancement[ One CMR performed at days 4-6 post MI]

Secondary Outcome Measures

Name	Time	Method
Incidence of clinical events (death, MI, target vessel revasularization)[30 days post randomisation];Procedural success as assessed by coronary angiographic flow indices including Thrombolysis In Myocardial Infarction (TIMI) flow grade, corrected TIMI frame count (cTFC), and myocardial blush grade (MBG) in the infarct-related artery and cTFC in the non-infarct related artery.[Baseline at the time of the angioplasty.];Incidence and magnitude of CMR defined microvascular obstruction (MVO) and intramyocardial haemorrhage (IMH)[Assessed by CMR completed once at 4-6 days post MI]