Early Use of Rosuvastatin in Acute Coronary Syndromes: Targeting Platelet-Leukocyte Interactions
Status: | Completed |
---|---|
Conditions: | Cardiology, Hematology |
Therapuetic Areas: | Cardiology / Vascular Diseases, Hematology |
Healthy: | No |
Age Range: | 18 - 80 |
Updated: | 11/30/2013 |
Start Date: | June 2011 |
End Date: | May 2013 |
Contact: | Susan S Smyth, MD, PhD |
Email: | susansmyth@uky.edu |
Phone: | 859-323-2274 |
Early Use of Rosuvastatin (Crestor) in Acute Coronary Syndromes: Targeting Platelet-Leukocyte Interactions
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.
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
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