Impact of Early PCSK9 Inhibitor on Heart After Acute Myocardium Infarction

Launched by SHANGHAI TONG REN HOSPITAL · Jan 28, 2021

Keywords

ClinConnect Summary

This clinical trial is studying how an early treatment with a medication called a PCSK9 inhibitor can help the heart after a heart attack (specifically, an acute myocardial infarction, or AMI). The goal is to see if giving this medication before a common heart procedure (called primary percutaneous coronary intervention or PPCI) can improve the heart's recovery and prevent changes in its structure. The trial will involve 20 participants who are 18 to 80 years old and have had successful heart surgery for a blocked artery.

Participants in the trial will be randomly assigned to two groups: one will receive standard care, while the other will get the PCSK9 inhibitor before their procedure and then continue taking it twice a month for three months. After six months, doctors will evaluate how well the heart has healed. Eligible participants are those who have had a heart attack and undergone the right type of surgery, but there are some exclusions, like individuals with certain health conditions or those planning to become pregnant. This study is currently recruiting participants, and it's important for anyone interested to understand the study requirements and provide consent before joining.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Subject must be at least 18 years of age and less than 80 years old
• • 2. Patients should have undergone successful percutaneous coronary intervention with drug-eluting stent for AMI and LAD should be the only culprit vessel.
• • 3. Subject understand the study requirements and the treatment procedures and provided informed consent before the procedure
• Exclusion Criteria:
• • 1. Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study
• • 2. Known hypersensitivity or contraindication to study medications
• • 3. Plan to receive revascularization in next six month.
• • 4. Have received revascularization before.
• • 5. Subjects with life expectation less than one year.
• • 6. Subjects with active malignant tumor
• • 7. subjects with severe liver or renal dysfunction（ALT \>5倍ULA，eGFR\<15ml/min/1.73mm2）
• • 8. Other conditions which the investigators think not applicable to the study.