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

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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
We found this trial at
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Lexington, Kentucky 40536
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