Table 2.

Inclusion and exclusion criteria

Inclusion criteria
1	Patient's age is ≥18
2	Patient satisfies criteria for ischemic stroke: acute focal neurological deficit of likely ischemic vascular origin
3	Patient or legally authorized representative has provided written informed consent prior to study entry
4	Patient can receive first treatment dose within 0–24 h of stroke onset; for patients found with stroke on awakening, it will be assumed that the stroke occurred the last time they were known to be normal
5	Patient has pretreatment brain CT scan compatible with ischemic stroke that excludes hemorrhagic and nonvascular etiologies of symptoms
6	Patients taking statins at time of stroke may be included
Exclusion criteria
1	Brain imaging study shows lesion other than ischemic stroke that could explain patient's symptoms (intracranial or subarachnoid hemorrhage, arteriovenous malformation, aneurysm, multiple sclerosis, tumor, abscess or other); asymptomatic meningiomas are allowed
2	Mild stroke, defined as NIHSS <2
3	Patient has received or is expected to receive intravenous rt-PA within 3 h or intra-arterial rt-PA within 6 h of stroke onset, according to our institutional standard of care
4	Patient has received intravenous rt-PA after 3 h or intra- arterial rt-PA after 6 h after stroke onset
5	Patient is comatose, regardless of etiology (>4 points on the first 3 items of the NIHSS)
6	Patient has history of intolerance or allergic reaction to any statins (myotoxicity, hepatic dysfunction, rash or other)
7	Patient has used drugs within past 30 days that utilize the cytochrome CYP3A pathway (cyclosporine, itraconazole, ketoconazole, erythromycin, azithromycin, clarithromycin or nefazodone)
8	Patient has used drugs within past 30 days that increase risk of myotoxicity with statins (gemfibrozil, other fibrates, niacin, amiodarone or verapamil)
9	Baseline major electrolyte disturbances (sodium <125 or >150, potassium <3.0 or >5.5)
10	Recent major trauma (<3 months)
11	Hypothermia (body temperature <96°F)
12	Baseline hypoxia (defined as oxygen saturation <92% on room air)
13	Patient has history of likely or proven systemic viral infection within 30 days
14	Patient has known HIV infection or used protease inhibitors
15	Endocarditis likely as cause of stroke
16	Mitochondrial disorder likely as cause of stroke
17	Pregnancy or lactation
18	Patient has history of rhabdomyolysis, myopathy or other severe muscle disease
19	Patient has history of hepatitis, decompensated liver disease (ascites, bleeding varices or encephalopathy) or liver failure
20	Liver function tests (ALT, AST) =2 × upper limit of normal
21	Unstable cardiovascular (including uncontrolled symptoms (intracranial hypertension), pulmonary, gastrointestinal, hepatic or musculoskeletal disease
22	Patient has evidence of congestive heart failure or has history of end-stage cardiovascular disease (e.g. CHF NYHA class III or IV or unstable angina)
23	Abnormal ECG showing: hemodynamically significant arrhythmia or frequent PVCs (>5/min; controlled atrial arrhythmia will not be an exclusion criterion); evidence of acute myocardial infarction; Mobitz II 2nd-degree AV block or 3rd-degree AV block; ventricular tachycardia or ventricular fibrillation
24	Significant renal insufficiency, indicated by serum creatinine >2.0 mg/dl
25	Hypoglycemia (glucose <60 mg/dl) or diabetic ketoacidosis unresponsive to therapy
26	Any of these hematologic abnormalities: Hb <10 g/dl; WBC <3.0 × 103/mm3; platelet count <50,000/mm3
27	Patient has received investigational drug within 30 days
28	Patient has severe behavioral or social problems that may interfere with the conduct of clinical study procedures
29	Patient is unlikely, in the investigator's opinion, to complete the study and return for follow-up visits for any reason

NIHSS = National Institutes of Health Stroke Scale; rt-PA = recombinant tissue-type plasminogen activator; CHF = congestive heart failure; NYHA = New York Heart Association; PVC = premature ventricular contraction; AV = atrioventricular; Hb = hemoglobin; WBC = white blood count.