Early Initiation of Tafolecimab for Patients With Acute Coronary Syndromeundergoing Percutaneous Coronary Intervention in Chinese Population

• Status: Not yet recruiting
• Trial end date: 2027-11-01
• Target enrollment: 0
• Participant gender: All

Summary

For patients with ACS undergoing PCI, intensive lipid-lowering including PCSK9 monoclonal antibody should be started as soon as possible, that is, lower LDL-C level should be achieved as soon as possible. Compared with conventional lipid-lowering regimen, it is expected that the occurrence of major adverse cardiovascular events can still be reduced after drug discontinuation. Therefore, the optimization strategy of "for patients with ACS undergoing PCI, intensive lipid-lowering with PCSK9 monoclonal antibody can be started as soon as possible" is proposed.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: China National Center for Cardiovascular Diseases
• Collaborator: Innovent Biologics, Inc.

Criteria

Inclusion Criteria:

• Patients aged 18 to 75 years;

• clinical diagnosis with non-ST-segment elevation acute coronary syndrome (NSTE-ACS) ;

• undergoing PCI

• baseline LDL-C 1.8 mmol/L 3.4 mmol/L note: NSTE-ACS includes non-ST-elevation myocardial infarction and unstable angina.

Exclusion Criteria:

• Severe heart failure (Killip III or IV) or cardiogenic shock;

• Previous hemorrhagic cerebrovascular disease history;

• Uncontrolled or recurrent arrhythmic events;

• poorly controlled hypertension;

• Severe hepatic and renal insufficiency (ALT/AST> 3 times upper limit of normal, eGFR<30 ml/kg/1.73m2, or ongoing dialysis) or creatine kinase elevation>5 times upper limit of normal

• malignant tumor;

• Intolerance to statins or cholesterol absorption inhibitors;

• Intolerance to injections;

• Life expectancy <1 year;

• poor compliance.