Status:
COMPLETED
Early Use of Rosuvastatin in Acute Coronary Syndromes: Targeting Platelet-Leukocyte Interactions
Lead Sponsor:
Susan Smyth
Conditions:
Acute Coronary Syndrome
Angioplasty, Transluminal, Percutaneous Coronary
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
Brief 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 ...
Eligibility Criteria
Inclusion
- Subjects must be between 18 and 80 years old.
- Subjects must be willing and able to give informed consent
- 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.
- 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.
- Subjects must be statin naive or currently only on low dose statin (Simvastatin 20mg, Pravastatin 40mg, or Atorvastatin 10mg)
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT01241903
Start Date
June 1 2011
End Date
February 1 2014
Last Update
March 28 2017
Active Locations (1)
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1
University of Kentucky Dept of Cardiology
Lexington, Kentucky, United States, 40536