Early Use of Rosuvastatin in Acute Coronary Syndromes: Targeting Platelet-Leukocyte Interactions

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Susan Smyth, University of Kentucky
ClinicalTrials.gov Identifier:
NCT01241903
First received: November 12, 2010
Last updated: May 21, 2014
Last verified: May 2014

November 12, 2010
May 21, 2014
June 2011
August 2013   (final data collection date for primary outcome measure)
Platelet - Leukocyte Aggregates [ Time Frame: within first 24 hours ] [ Designated as safety issue: No ]
measured by flow cytometry
Same as current
Complete list of historical versions of study NCT01241903 on ClinicalTrials.gov Archive Site
Biomarkers of Platelet Function and Myocardial Necrosis [ Time Frame: up to 30 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Early Use of Rosuvastatin in Acute Coronary Syndromes: Targeting Platelet-Leukocyte Interactions
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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Acute Coronary Syndrome
  • Angioplasty, Transluminal, Percutaneous Coronary
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors
  • Blood Platelets
  • Drug: rosuvastatin
    Patients (n = 54) presenting acute coronary syndrome/non-ST elevation myocardial infarction who present within 8 hours of symptom-onset will be randomized to two groups to receive rosuvastatin (40 mg oral dose) or placebo at the time of presentation, in addition to standard of care (aspirin, clopidogrel, low molecular weight heparin). Blood will be collected at baseline (time of enrollment, immediately prior to drug or placebo), at 6 - 8 hours, at 18 - 24 hours, and at 30 days for analysis of platelet - leukocyte co-aggregate formation, biomarkers of platelet - leukocyte interactions, and biomarkers of myocardial necrosis. Additional samples may be collected just after revascularization, in patients undergoing PCI. The group of patients treated with rosuvastatin will be maintained on rosuvastatin 20 mg daily and the group randomized to placebo will be given rosuvastatin (20 mg oral once daily) within 48 hoursof enrollment and after planned PCI, but before hospital discharge.
    Other Name: crestor
  • Drug: placebo
    frequency and duration
  • Experimental: Crestor
    Intervention: Drug: rosuvastatin
  • Placebo Comparator: sugar pill
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
54
February 2014
August 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01241903
10-208-F1V
Yes
Susan Smyth, University of Kentucky
University of Kentucky
Not Provided
Principal Investigator: Susan S Smyth, MD, PhD University of Kentucky
University of Kentucky
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP