Early Use of Rosuvastatin in Acute Coronary Syndromes: Targeting Platelet-Leukocyte Interactions
Completed · Phase 1 · Has a placebo group
Conditions studied: Acute Coronary Syndrome, Angioplasty, Transluminal, Percutaneous Coronary, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Blood Platelets
In brief
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.
Key facts
- Study ID
- NCT01241903
- Run by
- Susan Smyth
- People needed
- 54
- Starts
- 2011-06-01
- Expected to finish
- 2014-02-01
- Last updated by the study team
- 2017-03-28
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- University of Kentucky Dept of Cardiology — Lexington, Kentucky, United States
Full record on ClinicalTrials.gov
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