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

Susan Smyth

Status and phase: Completed; Phase 1

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

Treatments: Drug: placebo; Drug: rosuvastatin

Study type: Interventional

Funder types: Other

Identifiers

NCT01241903

10-208-F1V

Details and patient eligibility

About

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.

Enrollment: 54 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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54 participants in 2 patient groups, including a placebo group

Crestor

Experimental group

Treatment:

Drug: rosuvastatin

sugar pill

Placebo Comparator group

Treatment:

Drug: placebo