Phase I trial of ADR-002K for patients with ischemic cardiomyopathy who undergo coronary artery bypass surgery

JRCT ID: jRCT2053190103

Registered date:31/01/2020

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Ischemic cardiomyopathy undergoing coronary artery bypass surgery
• Date of first enrollment: 27/11/2019
• Target sample size: 6
• Study type: Interventional
• Intervention(s): Bypass surgery and ADR-002K administration

Outcome(s)

Primary Outcome

1) Adverse event and safety evaluation related to this product
2) Efficacy(exploratory)
3) Feasibility

Secondary Outcome

1) Cardiac function
2) Exercise tolerance
3) Other

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 80age old
• Gender: Both

Include criteria

1) Patients who are clinically diagnosed with ischemic cardiomyopathy and receive CABG
2) Patients with a left ventricular ejection fraction of 40% or less by cardiac ultrasonography within 4 weeks before obtaining consent
3) Others

Exclude criteria

1) Patients who have a combination of cardiovascular disease such as severe organic valvular disease or aortic aneurysm determined by investigator or co-investigator to affect clinical trial procedure
2) Patients whose participation in a clinical trial is considered inappropriate at the discretion of the investigator or co-investigator
3) Others

Related Information

• Primary Sponsor: SAWA Yoshiki
• Source(s) of Monetary Support: Rohto phermaceutical Co.,Ltd.
• Secondary ID(s): UMIN000038809