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)

JRCT ID: jRCT2051240065

Registered date:13/06/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Ischemic cardiomyopathy
• Date of first enrollment: 13/06/2024
• Target sample size: 20
• Study type: Interventional
• 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.

Outcome(s)

• Primary Outcome: To evaluate the safety and tolerability of continuously intravenous administration of redasemtide after coronary artery bypass surgery.
• Secondary Outcome: The 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
• Gender: Both

Include criteria

1) 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 criteria

1) 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

• Primary Sponsor: Shigeru Miyagawa
• Source(s) of Monetary Support: Shionogi Pharma Co., Ltd.