carotid plaque
Conditions
Interventions
Oral administration of statins with maximum tolerated dose for 48 weeks.
Subcutaneous administration of evolocumab 140 mg once every two weeks for 48 weeks.
Sponsors
Iwate Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) 20 years and over 2) History of non cardiogenic cerebral infarction 3) IMT >= 1.1 mm 4) Sttains have been administered for 3 months or longer with maximum tolerated dose without changes in dose. 5) LDL-C >= 120 mg/dL
Exclusion criteria
Exclusion criteria: 1) History of coronary artery disease or valvular disease or heart failure of NYHA class 3 or higher 2) Arrhythmia with poor control within 3 months 3) High blood pressure with poor control(systolic blood pressure at rest > 180 mmHg) 4) Type 1 diabetes or poorly controlled diabetes (HbA1c > 9.0 %) 5) Creatine kinase is at least 3 times higher than normal upper limit. 6) History of PCSK9 inhibitor administration in the past. 7) History of administration of cyclosporine and steroid for more than 2 weeks within 3 months before entry of the study. 8) History of malignant tumor. 9) Active infectious diseases, renal failure, blood diseases, gastrointestinal diseases and metabolic diseases oher than diabetes / dyslipidemia 10) Pregnancy 11) Inability to evaluate by carotid ultrasonography by calcification. 12) Other conditions which the physician deems inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in IMT from baseline to week 48. | — |
Countries
Japan
Contacts
Public ContactKazumasa Oura
Iwate Medical University Department of Internal medicine, Division of Neurology and Gerontology
Outcome results
None listed