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

NCT ID: NCT01241903

Last Updated: 2017-03-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2014-02-28

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Crestor

Group Type: EXPERIMENTAL

rosuvastatin

Intervention Type: DRUG

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.

sugar pill

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

frequency and duration

Interventions

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.

Intervention Type: DRUG

placebo

frequency and duration

Intervention Type: DRUG

Other Intervention Names

crestor

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Susan Smyth

OTHER

Sponsor Role: lead

Responsible Party

Susan Smyth

Principal investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Susan S Smyth, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Locations

University of Kentucky Dept of Cardiology

Lexington, Kentucky, United States

Countries

United States

Other Identifiers

10-208-F1V

Identifier Type: -

Identifier Source: org_study_id