Hypercholesterolemia
Conditions
Interventions
High-dose rosuvastatin group: Weeks 0-4: Rosuvastatin 10 mg administered orally once daily.* From Week 4: Rosuvastatin 20 mg administered orally once daily.* * However, if LDL-C is <
50 mg/dL, continue treatment until Week 96 without increasing dose.
Low-dose rosuvastatin group: Rosuvastatin 2.5 mg administered orally once daily.
Sponsors
ALTAIR Study
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects Patients with elevated LDL cholesterol and yellow plaque (>= Grade 2) in addition to the lesion in question, and who satisfy the following conditions will be admitted to this study: 1) Patients with dyslipidemia Patients who do not meet the JAS guidelines (LDL-C: >= 100 mg/dL) 2) Male or female inpatients/outpatients who are at least 20 yrs at the time of consent 3) Patients who are capable of giving written consent Target plaque The lesion in question will be yellow plaque. Intravascular ultrasound (IVUS) and angio-endoscopy will evaluate the same region of the lesion. Moderately or severely calcified plaque, or other plaque which cannot be evaluated, will not be included in the study.
Exclusion criteria
Exclusion criteria: 1) Patients whose onset of acute coronary syndrome is <= 24 h 2) Patients who will require bypass surgery <= 48 h 3) Patients with familial hypercholesterolemia or secondary hypercholesterolemia 4) Patients whose fasting serum is TG >= 400 mg/dL 5) Patients with a history of hypersensitivity to statins 6) Patients with serious diabetes mellitus (HbA1c >= 8.5%) 7) Patients with active liver disease (ALT or AST: > 100 IU/L, total bilirubin: > 2.5 mg/dL) 8) Patients with renal impairment (serum Cr >= 2.0 mg/dL or Ccr < 30 mL/min [Cockcroft-Gault formula]) 9) Patients receiving ciclosporin treatment 10) Patients who are, or who may possibly be, pregnant 11) Patients with hypothyroidism, genetic muscular disorder (e.g., muscular dystrophy) or a family history thereof, patients with a history of drug-related muscular disorders 12) Patients who are drug abusers or alcoholics 13) Other patients whom the investigator considers unsuitable for inclusion in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in yellow plaque | — |
Countries
Japan
Outcome results
None listed