Early Use of Rosuvastatin in Acute Coronary Syndromes: Targeting Platelet-Leukocyte Interactions

• Status: Completed
• Trial end date: 2014-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The central hypothesis for this work is that platelet - leukocyte interactions play a critical role in the pathogenesis of acute ischemic events. The primary objective of the study is to determine if early, high-dose administration of the HMG-CoA reductase inhibitor rosuvastatin in the setting of acute coronary syndrome and percutaneous coronary intervention exerts beneficial vascular effects by reducing platelet - leukocyte interactions.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Susan Smyth; University of Kentucky
• Treatments: Rosuvastatin Calcium

Criteria

Inclusion Criteria:

1. Subjects must be between 18 and 80 years old.

2. Subjects must be willing and able to give informed consent

3. A woman of child-bearing potential who is currently sexually active must agree to use a medically accepted method of contraception while receiving protocol-specified medication and for up to 30 days after enrollment.

4. Subjects must have symptoms of acute coronary syndrome as defined by 2 of the 3: (a) history of cardiac-ischemia-related symptoms of at least 10 minutes duration ≤ 8 hours prior to randomized treatment assignment (b) concurrent biomarker evidence of cardiac ischemia, as defined by troponin I or T greater that upper limit of normal (ULN) or creatine kinase-myocardial band (CK-MB) greater than ULN. (c) concurrent electrocardiographic evidence of cardiac ischemia, as defined by new of presumably new ST-segment depression (≥1 mm) or transient (<30 min) ST-segment elevation (≥ 1mm) in at least two contiguous leads.

5. Subjects must be statin naive or currently only on low dose statin (Simvastatin 20mg, Pravastatin 40mg, or Atorvastatin 10mg)

Exclusion Criteria:

• Age <18 years

• Age > 80 years

• Use of Crestor in the past 30 days

• GFR (estimated) <30 ml/min

• Hemodialysis

• History of liver failure

• Unexplained liver function abnormalities

• Current or planned use of cyclosporine or gemfibrozil

• Sepsis

• Hypotension

• Dehydration

• Trauma

• Severe metabolic, endocrine or electrolyte abnormality

• Recent (within the last 2 weeks) or planned (in the next month) major surgery

• HIV/AIDS with current of planned use of HIV protease inhibitors