Early Initiation of PCSK9 Inhibitor Tafolecimab in ACS Patients Undergoing PCI

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 4 interventional study assesses whether initiating the PCSK9 inhibitor tafolecimab soon after hospital admission for ACS and during PCI achieves faster and greater LDL-C lowering versus standard lipid-lowering approaches. Eligible adults with non-ST elevation ACS undergoing PCI and elevated baseline LDL-C receive tafolecimab in addition to statins or statin-based therapy, with or without a cholesterol absorption inhibitor. The trial tracks major adverse cardiovascular events and lipid levels to determine potential long-term benefits after treatment discontinuation. The study reflects a strategy to optimize timing of potent lipid-lowering therapy in ACS patients within the Chinese population.

Why it matters

Who can join: the full rules

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.

Where it's running

• Fuwai Hospital
  Beijing, Beijing Municipality, China Recruiting
• Tangshan Central Hospital
  Tangshan, Hebei, China Recruiting

Study contacts

• Principal investigator: Na-Qiong Wu, Doctor — Chinese Academy of Medical Sciences, Fuwai Hospital
• Study coordinator: Na-Qiong Wu, Doctor
• Email: wunaqiong@fuwaihospital.org
• Phone: 86-88398866

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.