Rosuvastatin in African Americans With Cerebrovascular Disease
Rosuvastatin in African Americans With Cerebrovascular Disease
This study will assess the rate at which rosuvastatin will achieve LDL targets in African
 American patients with previous history of stroke or TIA.
Background:

 Blacks have twice the risk of stroke compared to Whites and a recent analysis found that
 stroke incidence was decreasing in Whites but not Blacks. Identifying new avenues for stroke
 prevention is important in African Americans.

 The Stroke Prevention through Aggressive Reduction of Cholesterol Levels (SPARCL) trial
 showed that treatment with atorvastatin 80 mg/d reduced the frequency of stroke by 16%. In
 the SPARCL trial, the mean low density lipoprotein-cholesterol (LDL-C in the treatment group
 was 73 mg/dl. On the basis of the SPARCL trial, the American Stroke Association now
 recommends statins with "intensive lipid lowering effects" for secondary prevention in the
 2008 guideline update. Achieving target levels is most important for secondary prevention of
 stroke, when patients have an annual risk of stroke recurrence of 3-15% per year.
 Rosuvastatin is well suited for these secondary prevention goals due to its potent
 lipid-lowering effects.

 Objectives

 The objectives of this study are to establish the following:

 1. That a dose escalation regimen of rosuvastatin 20-40 mg will achieve 70% success in
 reaching the LDL-C target of <100 mg/dl

 2. That a dose escalation regimen of rosuvastatin 20-40 mg will achieve 50% success in
 reaching the LDL-C target of <70 mg/dl for individuals at highest risk

 Design

 60 patients will be identified from the inpatient and outpatient settings from two medical
 centers. African American patients with a diagnosis of ischemic stroke or transient ischemic
 attack (TIA) within the previous 12 months will be identified.

 Both patients already on other statins and statin naïve patients will be recruited. For
 patients on other statins, a washout period will not be required due to ethical reasons.
 After providing informed consent, baseline lipid values will be obtained. Study subjects will
 be initiated on a starting dose of rosuvastatin of 20 mg. Subjects will be followed every six
 weeks for a 3 month period. A lipid profile and LFT's will be obtained at 6 weeks and 3
 months. Patients not at the intensive LDL-C target of <70 mg/dl will be increased to 40 mg,
 if necessary.

 The final 3 month lipid profile will be used to determine achievement of the targets.

 Treatments

 Rosuvastatin 20 mg will be the starting dose. As described above, patients may be titrated to
 40 mg if the 6 week LDL cholesterol is >70 mg/dl.

 Safety monitoring Adverse Event An Adverse Event (AE) is the development of an undesirable
 medical condition or the deterioration of a pre-existing medical condition following or
 during exposure to a pharmaceutical product, whether or not considered causally related to
 the product. An undesirable medical condition can be symptoms (eg, nausea, chest pain), signs
 (eg, tachycardia, enlarged liver) or the abnormal results of an investigation (eg, laboratory
 findings, ECG). In clinical studies, an AE can include an undesirable medical condition
 occurring at any time, including run-in or washout periods, even if no study treatment has
 been administered.

 Any detrimental change in a patient's condition subsequent to them entering the study and
 during the follow-up period should be considered an AE. When there is a deterioration in the
 condition for which the study treatment is being used, there may be uncertainty as to whether
 this is lack of efficacy or an AE. In such cases, unless the reporting physician considers
 that study treatment contributed to the deterioration or local regulations state to the
 contrary, the deterioration should be considered a lack of efficacy. Signs and symptoms of
 disease progression are therefore not considered AEs.
Inclusion Criteria:

 -  Age 30 and above

 -  Rankin score of ≤ 3

 -  Patient has a fixed telephone number and is available for follow-up

 -  African American

 -  Diagnosis of ischemic stroke or TIA in past 12 months

 Exclusion Criteria:

 -  Liver enzyme abnormalities (ALT or AST >2x ULN)

 -  Known muscle disorder or CK > 5x ULN

 -  Alcoholism or substance abuse

 -  Stroke due to dissection or hypercoagulable state

 -  Moderate to severe dementia (MMSE <20)

 -  On hemodialysis

 -  No fixed home address