To investigate the effects of early in-hospital intensive lipid-lowering therapy (LLT) with proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors on lipid dynamics and clinical outcomes in Chinese acute coronary syndrome (ACS) patients, providing robust real-world evidence for its long-term benefits and optimal implementation timing to address the evidence gap in optimal lipid management for secondary prevention.

This multicenter prospective real-world study (http://www.clinicaltrials.gov, NCT number: NCT06738758), which building upon the ELEGANT pilot registry (ChiCTR2200065861), will enroll 6000 consecutively hospitalized ACS patients with uncontrolled dyslipidemia across more than 30 Chinese centers. Participants are enrolled based on recommended stratified proportions [(1) diagnostic categories: ST-segment elevation myocardial infarction : non-ST-segment elevation myocardial infarction : intermediate-high-risk unstable angina = 1:1:3; and (2) lipid-lowering strategies: PCSK9 inhibitor ± statin : statin+ezetimibe/hybutimibe : statin = 2:1:2). Treatment assignment reflects real-world clinical decisions guided by low-density lipoprotein cholesterol levels and patient preference. Twelve-month follow-up assessments were conducted at predefined intervals: baseline hospitalization, discharge, and 1, 3, 6, 12 months post-discharge. Primary endpoints were the goal attainment (low-density lipoprotein cholesterol < 1.4 mmol/L) rates across treatment arms. Key secondary endpoints were the major adverse cardiovascular events (including myocardial infarction, ischemic stroke, cardiovascular mortality, coronary revascularization) and all-cause death, and other secondary endpoints encompassed time-to-lipid-goal, longitudinal changes in lipids profiles and inflammatory biomarkers, and perivascular fat attenuation index evolution quantified by coronary computed tomographic angiography. Propensity score matching and inverse probability treatment weighting will address confounding bias.

This study will pioneer evidence clarifying the optimal therapeutic window and clinical benefits of in-hospital intensive LLT for Chinese ACS patients. By establishing the first Chinese population-derived evidence for the “early intensive and rapid target attainment” strategy, our findings may challenge stepwise LLT paradigms. These results may guide international guideline updates for high-risk ACS populations, particularly in East Asian cohorts with distinct lipid profiles.

To evaluate the feasibility and tolerability of metoprolol standard dosing pathway (MSDP) in Chinese patients with acute coronary syndrome (ACS).

In this multicenter, prospective, open label, single-arm and interventional study that was conducted from February 2018 to April 2019 in fifteen Chinese hospitals. A total of 998 hospitalized patients aged ≥ 18 years and diagnosed with ACS were included. The MSDP was applied to all eligible ACS patients based on the standard treatment recommended by international guidelines. The primary endpoint was the percentage of patients achieving the target dose at discharge (V2). The secondary endpoints included the heart rate and blood pressure at V2 and four weeks after discharge (V4), and percentage of patients experiencing bradycardia (heart rate < 50 beats/min), hypotension (blood pressure < 90/60 mmHg) and transient cardiac dysfunction at V2 and V4.

Of the 998 patients, 29.46% of patients achieved the target dose (≥ 95 mg/d) at V2. The total population was divided into two groups: target group (patients achieving the target dose at V2) and non-target group (patients not achieving the target dose at V2). There was significant difference in the reduction of heart rate from baseline to discharge in the two groups (-4.97 ± 11.90 beats/min vs. -2.70 ± 9.47 beats/min, P = 0.034). There was no significant difference in the proportion of bradycardia that occurred in the two groups at V2 (0 vs. 0, P = 1.000) and V4 (0.81% vs. 0.33%, P = 0.715). There was no significant difference in the proportion of hypotension between the two groups at V2 (0.004% vs. 0.004%, P = 1.000) and V4 (0 vs. 0.005%, P = 0.560). No transient cardiac dysfunction occurred in two groups during the study. A total of five adverse events (1.70%) and one serious adverse event (0.34%) were related to the pathway in target group.

In Chinese ACS patients, the feasibility and tolerability of the MSDP have been proved to be acceptable.