Early Use of Rosuvastatin in Acute Coronary Syndromes: Targeting Platelet-Leukocyte Interactions
This study is currently recruiting participants.
Verified November 2012 by University of Kentucky
Sponsor:
University of Kentucky
Information provided by (Responsible Party):
Susan Smyth, University of Kentucky
ClinicalTrials.gov Identifier:
NCT01241903
First received: November 12, 2010
Last updated: November 13, 2012
Last verified: November 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Coronary Syndrome Angioplasty, Transluminal, Percutaneous Coronary Hydroxymethylglutaryl-CoA Reductase Inhibitors Blood Platelets |
Drug: rosuvastatin Drug: placebo |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Early Use of Rosuvastatin (Crestor) in Acute Coronary Syndromes: Targeting Platelet-Leukocyte Interactions |
Resource links provided by NLM:
Further study details as provided by University of Kentucky:
Primary Outcome Measures:
- platelet - leukocyte aggregates [ Time Frame: within first 24 hours ] [ Designated as safety issue: No ]measured by flow cytometry
Secondary Outcome Measures:
- biomarkers of platelet function and myocardial necrosis [ Time Frame: up to 30 days ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 54 |
| Study Start Date: | June 2011 |
| Estimated Study Completion Date: | May 2013 |
| Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Crestor |
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
|
| Placebo Comparator: sugar pill |
Drug: placebo
frequency and duration
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01241903
Contacts
| Contact: Susan S Smyth, MD, PhD | 859-323-2274 | susansmyth@uky.edu |
Locations
| United States, Kentucky | |
| University of Kentucky Dept of Cardiology | Recruiting |
| Lexington, Kentucky, United States, 40536 | |
| Contact: Susan Smyth, MD 859-323-2274 ssmyt2@email.uky.edu | |
| Principal Investigator: Susan Smyth, MD | |
Sponsors and Collaborators
University of Kentucky
Investigators
| Principal Investigator: | Susan S Smyth, MD, PhD | University of Kentucky |
More Information
No publications provided
| Responsible Party: | Susan Smyth, Principal investigator, University of Kentucky |
| ClinicalTrials.gov Identifier: | NCT01241903 History of Changes |
| Other Study ID Numbers: | 10-208-F1V |
| Study First Received: | November 12, 2010 |
| Last Updated: | November 13, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of Kentucky:
|
Platelet activation platelet leukocyte aggregates |
Additional relevant MeSH terms:
|
Acute Coronary Syndrome Myocardial Ischemia Heart Diseases Cardiovascular Diseases Angina Pectoris Vascular Diseases Chest Pain Pain Signs and Symptoms Rosuvastatin |
Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Enzyme Inhibitors Lipid Regulating Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013