Clinical trial NCT01241903: Early Use of Rosuvastatin in Acute Coronary Syndromes: Targeting Platelet-Leukocyte Interactions
Official title: Early Use of Rosuvastatin (Crestor) in Acute Coronary Syndromes: Targeting Platelet-Leukocyte Interactions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Acute Coronary Syndrome
Angioplasty, Transluminal, Percutaneous Coronary
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Blood Platelets
Keywords: Platelet activation
platelet leukocyte aggregates
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2010-11-16
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.


Eligibility 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

Primary outcomes:
measure: Platelet - Leukocyte Aggregates
timeFrame: within first 24 hours
Secondary outcomes:
measure: Biomarkers of Platelet Function and Myocardial Necrosis
timeFrame: up to 30 days
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky Dept of Cardiology
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Susan S Smyth, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: