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

Acute Coronary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01241903
• Other study ID #: 10-208-F1V
• Status: Completed
• Phase: Phase 1
• First received: November 12, 2010
• Last updated: May 21, 2014
• Start date: June 2011
• Est. completion date: February 2014

Study information

• Verified date: May 2014
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: February 2014
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Angioplasty, Transluminal, Percutaneous Coronary
• Blood Platelets
• Hydroxymethylglutaryl-CoA Reductase Inhibitors
• Syndrome

Intervention

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.
• placebo
frequency and duration

Locations

Country	Name	City	State
United States	University of Kentucky Dept of Cardiology	Lexington	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
University of Kentucky

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Platelet - Leukocyte Aggregates	measured by flow cytometry	within first 24 hours	No
Secondary	Biomarkers of Platelet Function and Myocardial Necrosis		up to 30 days	No