The crossover randomized controlled clinical trial with Alirocumab and Evolocumab:CROSS ALIVE Study
Conditions
Interventions
Before switching from 75 mg, 150 mg arilocumab to 140 mg, 420 mg evolocumab, and 3 months after the switch.
Before switching from 140 mg, 420 mg evolocumab to 75 mg, 150 mg arilocumab, and 3 months af
Sponsors
Saitama Medical University Dept. of Endocrinology and Diabetology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)-3) 3 examine group 1)T2DM with 120 mg/dl or more than 100 mg/dl LDL-C 2)Patients of JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2017 CategoryIII (Diabetes patients are excepted) with 120 mg/dl or more than 100 mg/dl LDL-C 3)Patients of JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2017 Secondary prevention with 100 mg/dl or more than 70 mg/dl LDL-C
Exclusion criteria
Exclusion criteria: A patient with the side-effects past in statin medication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Lipid profile (TC,TG,HDL-C, Friedewald LDL-C,small dense LDL,IDL,Lp(a),LDL oxidation ability,LDL stability,oxidized LDL,3%PAGE,Agarose gel electrophoresis,electronegative LDL),apo protein, apoE phenotype, Ultracentrifugation, gel filtration, ion exchange chromatography | — |
Secondary
| Measure | Time frame |
|---|---|
| Cr, BUN, Urinal analysis, GOT, GPT, CK, (following in the case of DM), fasting blood glucose, HbA1, hematologic changes such as thrombocytopenia, etc., early-phase and late-phase of allergic reaction to PCSK9 inhibitor. | — |
Countries
Japan
Contacts
Public ContactIkuo Inoue
Saitama Medical University Dept. of Endocrinology and Diabetology
Outcome results
None listed