Acute Myocardial Infarction
Conditions
Brief summary
This is a double-blinded randomized placebo controlled trial investigating the role of upstream 80mg Atorvastastin-calcium in patients undergoing percutaneous intervention for acute STEMI.
Interventions
DRUGAtorvastatin calcium
Eligible patients will receive 80mgs of atorvastatin orally upon admission to hospital prior to percutaneous intervention of the affected artery. Dose of post-procedural statin will be at the discretion of the cardiologist.
DRUGInactive Placebo
Eligible patients will receive a placebo orally upon admission to hospital prior to percutaneous intervention of the affected artery.
Sponsors
West Penn Allegheny Health System
The Western Pennsylvania Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
25 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1. Any patient of 25 to 90 years of age admitted or transferred to Western Pennsylvania Hospital or Allegheny General Hospital with a diagnosis of STEMI undergoing emergent percutaneous intervention (PCI) to the culprit coronary artery. STEMI is defined as greater than 1mm ST segment elevation on electrocardiogram. 2. Elevated cardiac biomarkers (troponin-T \> 0.03ng/ml, CKMB\>5ng/mL, or ck\>170 U/l).
Exclusion criteria
1. Known history of liver disease defined as cirrhosis, alcoholic liver disease, Non alcoholic steatohepatitis, hepatitis or any causes of liver failure. 2. Renal failure with creatinine \>3mg/dL 3. Known history of liver or muscle disease such as rheumatologic myopathies, history of myositis, hepatitis, and hepatic cancer. 4. Cardiovascular arrest and shock.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major adverse cardiovascular event (MACE) defined as cardiovascular death, MI, or target revascularization 30 days post percutaneous intervention. | 15 and 30 days post revascularization |
Secondary
| Measure | Time frame |
|---|---|
| Any increase in mean peak values of CK-MB, troponin I and myoglobin greater than twice the upper limit after intervention. | 15 and 30 days post revascularization |
| Any occurrence of major adverse cardiac events defined as death, MI, congestive heart failure, cardiogenic shock or need for unplanned revascularization within 24 hours after procedure or need for emergent CABG. | 15 and 30 days post revascularization |
| Symptomatic side effects of current statin medication as described by adverse effects on consent form. | Immediately post revascularization to 30 days. |
| Modified Coronary Revascularization Outcome Questionnaire (CROQ-PTCA) | 15 and 30 days post revascularization |
Countries
United States
Outcome results
None listed