Back to resultsEarly Use of Rosuvastatin in Acute Coronary Syndromes: Targeting Platelet-Leukocyte Interactions
Primary Purpose
Acute Coronary Syndrome, Angioplasty, Transluminal, Percutaneous Coronary, Hydroxymethylglutaryl-CoA Reductase Inhibitors
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
rosuvastatin
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Acute Coronary Syndrome focused on measuring Platelet activation, platelet leukocyte aggregates
Eligibility Criteria
Inclusion Criteria:
- 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)
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
Sites / Locations
- University of Kentucky Dept of Cardiology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Crestor
sugar pill
Arm Description
Outcomes
Primary Outcome Measures
Platelet - Leukocyte Aggregates
measured by flow cytometry
Secondary Outcome Measures
Biomarkers of Platelet Function and Myocardial Necrosis
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01241903
Brief Title
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
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
February 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Susan Smyth
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome, Angioplasty, Transluminal, Percutaneous Coronary, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Blood Platelets
Keywords
Platelet activation, platelet leukocyte aggregates
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Crestor
Arm Type
Experimental
Arm Title
sugar pill
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
rosuvastatin
Other Intervention Name(s)
crestor
Intervention Description
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
Intervention Name(s)
placebo
Intervention Description
frequency and duration
Primary Outcome Measure Information:
Title
Platelet - Leukocyte Aggregates
Description
measured by flow cytometry
Time Frame
within first 24 hours
Secondary Outcome Measure Information:
Title
Biomarkers of Platelet Function and Myocardial Necrosis
Time Frame
up to 30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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)
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan S Smyth, MD, PhD
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kentucky Dept of Cardiology
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Early Use of Rosuvastatin in Acute Coronary Syndromes: Targeting Platelet-Leukocyte Interactions
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