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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Crestor | Experimental |
| |
| sugar pill | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rosuvastatin | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Platelet - Leukocyte Aggregates | measured by flow cytometry | within first 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Biomarkers of Platelet Function and Myocardial Necrosis | up to 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susan S Smyth, MD, PhD | University of Kentucky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky Dept of Cardiology | Lexington | Kentucky | 40536 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Subjects randomized to the placebo arm received a placebo dose at enrollment (day 1) and rosuvastatin 20mg for the next 30 days starting on day 2. |
| FG001 | Rosuvastatin |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| placebo | Drug | frequency and duration |
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Subjects randomized to the rosuvastatin arm received rosuvastatin 40mg following enrollment (day 1) and rosustatin 20mg for the next 30 days starting at day 2.
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Subjects randomized to the placebo arm received a placebo dose at enrollment (day 1) and rosuvastatin 20mg for the next 30 days starting on day 2. |
| BG001 | Rosuvastatin | Subjects randomized to the rosuvastatin arm received rosuvastatin 40mg following enrollment (day 1) and rosustatin 20mg for the next 30 days starting at day 2. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Platelet - Leukocyte Aggregates | measured by flow cytometry | Posted | Mean | Standard Error | % leukocytes with platelets attached | within first 24 hours |
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| Secondary | Biomarkers of Platelet Function and Myocardial Necrosis | Not Posted | up to 30 days | Participants |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Subjects randomized to the placebo arm received a placebo dose at enrollment (day 1) and rosuvastatin 20mg for the next 30 days starting on day 2. | 2 | 26 | 2 | 26 | ||
| EG001 | Rosuvastatin | Subjects randomized to the rosuvastatin arm received rosuvastatin 40mg following enrollment (day 1) and rosustatin 20mg for the next 30 days starting at day 2. | 1 | 27 | 1 | 27 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | Subject had urine myoglobin 4 hours after randomization. Study drug was discontinued immediately. Symptoms resolved within 40 hours. No clinical signs of rhabdomyolysis were noted. Event was assessed moderate and possibly related to rosuvastatin. |
| ||
| Death | Cardiac disorders | Subject expired from a coronary event 10 days after enrollment. Subject had history of hypertension and a myocardial infarction the day of enrollment. The event was assessed as unrelated to rosuvastatin treatment and caused by underlying disease. |
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| Stroke | Blood and lymphatic system disorders | Subject suffered a stroke (acute left hemiparesis) 12 days after enrolling into the study. The stroke was assessed as Grade 3 (severe) and unrelated to rosuvastatin treatment and caused by underlying disease. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rash | Skin and subcutaneous tissue disorders | Subject developed rash 3 days after enrollment. Rash resolved after discontinuation of rosuvastatin. Event was assessed as mild and probably related to rosuvastatin. |
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| Alcohol Toxicity | Social circumstances | Subject experienced alcohol toxicity 12 days following enrollment. The event was accessed as mild and probably not related to rosuvastatin. |
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| Nightmare | Social circumstances | Subject complained of experiencing nightmares and flashbacks 14 days after enrollment. Rosuvastatin was discontinued and nightmares continued. The event was assessed as mild and unrelated to rosuvastatin treatment. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Susan S. Smyth | University of Kentucky | (859) 323-2274 | ssmyt2@uky.edu |
| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000068718 | Rosuvastatin Calcium |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| 24 Hour |
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