Phase 1
N=54
Early Use of Rosuvastatin in Acute Coronary Syndromes: Targeting Platelet-Leukocyte Interactions
Acute Coronary Syndrome · Angioplasty, Transluminal, Percutaneous Coronary · Hydroxymethylglutaryl-CoA Reductase Inhibitors · Blood Platelets
Bottom Line
View on ClinicalTrials.gov: NCT01241903 ↗Enrolled (actual)
54
Serious AEs
5.7%
Results posted
Jun 2014
Primary outcome: Primary: Platelet - Leukocyte Aggregates — 29.2; 39.8; 26.2; 21.1 % leukocytes with platelets attached
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- rosuvastatin (Drug); placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Susan Smyth
- Primary completion
- Aug 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Platelet - Leukocyte Aggregates |
29.2; 39.8; 26.2; 21.1; 24.4; 21.3 | — |
| SECONDARY Biomarkers of Platelet Function and Myocardial Necrosis |
— | — |
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.
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 ( 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
Data sourced from ClinicalTrials.gov (NCT01241903). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.