The crossover randomized controlled clinical trial with Alirocumab and Evolocumab:CROSS ALIVE Study

Phase 4

• Conditions: The crossover randomized controlled clinical trial with Alirocumab and Evolocumab:CROSS ALIVE Study

• Registration Number: JPRN-UMIN000040727
• Lead Sponsor: Saitama Medical University Dept. of Endocrinology and Diabetology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-06-12
• Last Update Posted: 17 October 2023
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

A patient with the side-effects past in statin medication

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ipid 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 Outcome Measures

Name	Time	Method
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.