NIPH Clinical Trials Search

JRCT ID: jRCT2051240065

Registered date:13/06/2024

Parallel-group, placebo-controlled study to evaluate the safety, tolerability, and efficacy of repeated intravenous administration of S-005151 to patients with ischemic cardiomyopathy undergoing coronary artery bypass surgery (Phase I/II)

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedIschemic cardiomyopathy
Date of first enrollment13/06/2024
Target sample size20
Countries of recruitment
Study typeInterventional
Intervention(s)After coronary artery bypass grafting, patients will be randomly assigned 1:1 to the investigational product group or placebo group, and the S-005151 or placebo will be administered continuously for 5 days.


Primary OutcomeTo evaluate the safety and tolerability of continuously intravenous administration of redasemtide after coronary artery bypass surgery.
Secondary OutcomeThe efficacy of continuously intravenous administration of redasemtide within 21 days after coronary artery bypass surgery for ischemic cardiomyopathy will be evaluated on the transition of cardiac function.

Key inclusion & exclusion criteria

Age minimum>= 45age old
Age maximum< 75age old
Include criteria1) Patients who diagnosed with ischemic cardiomyopathy and undergoing coronary artery bypass surgery through open heart surgery 2) LVEF <40% 3) Patients who taking medication for heart failure 4) NYHA class 2,3,4 5) Patients who can obtain written consent from the subject to participate in the clinical trial 6) Patients who can continue to visit the study site for 52 weeks after administering study drug
Exclude criteria1) Patients who concomitant severe cardiovascular abnormalities 2) Patients who irreversible organ failure other than the heart 3) Patients who NYHA class 4 and meet the following Uunder administration high-dose catecholamine Mechanically assisted circulatory support 4) History of active malignancy within 5 years 5) History of breast cancer within 10 years 6) Patients who pregnancy, do not agree to contraception,breastfeeding 7) Patients who cannot receive blood transfusions 8) Severe liver or renal dysfunction 9) Unstable liver disease or biliary tract disease 10) Alcoholism or drug addiction within 6 months before registration 11) Severe psychosis or psychotic symptoms 12) Severe drug allergy 13) Receiving treatment with procoagulants, antifibrinolytic agents, and aprotinin preparations 14) Participating in other clnical trials,within 6 months after participating in other clinical trial 15) Patients who have received Redasemtide treatment in the past 16) Patient deemed unsuitable as subjects

Related Information


Public contact
Name Yusuke Misumi
Address 2-15,Yamadaoka,Suita,Osaka Osaka Japan 565-0871
Telephone +81-6-6879-3154
Affiliation Osaka university hospital
Scientific contact
Name Miyagawa Shigeru
Address 2-15,Yamadaoka,Suita,Osaka Osaka Japan 565-0871
Telephone +81-6-6879-3154
Affiliation Osaka university hospital