PCSK 9 Inhibitor Added to High-Intensity Statin Therapy to Prevent Cardiovascular Events in Patie… (NCT05457582) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
PCSK 9 Inhibitor Added to High-Intensity Statin Therapy to Prevent Cardiovascular Events in Patients With ACS After PCI
China1,212 participantsStarted 2023-03-30
Plain-language summary
The primary objective was to evaluate the effect of PCSK 9 Inhibitor (initiated within 4 h from PCI for the culprit lesion) with high-intensity statin treatment, compared to placebo with high-intensity statin treatment, on cardiovascular events (including cardiovascular death, myocardial infarction, stroke, re-hospitalization due to acute coronary syndromes or heart failure, or any ischemia-driven coronary revascularization) in patients with acute coronary syndrome and multiple lesions. Alirocumab was used before June 10, 2025; Tafolecimab has been used from June 10, 2025 onward.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. The subject, or their legal guardian, must have a clear understanding of the trial's design and treatment procedures. They must provide written informed consent before any trial-specific tests or procedures are conducted.
. Both male and female subjects aged ≥18 years.
. Subjects who have experienced an ACS and have undergone PCI for culprit lesions (either QFR or FFR \< 0.8) are eligible. ACS is defined as:
. Low-density lipoprotein cholesterol ≥70 mg/dL (≥1.8 mmol/L) in patients who have been on a stable high-intensity statin regimen for at least 4 weeks before enrollment.
. Low-density lipoprotein cholesterol ≥90 mg/dL (≥2.3 mmol/L) in patients who have been on a moderate or low-intensity statin regimen before enrollment.
. Low-density lipoprotein cholesterol ≥125 mg/dL (≥3.2 mmol/L) in patients who are statin-naïve or have not been on a stable statin regimen for at least 4 weeks before enrollment.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is combining a PCSK9 inhibitor with high-intensity statin therapy after a heart attack or stent procedure — given my specific situation, does my doctor think adding a PCSK9 inhibitor on top of a statin is the right approach for managing my cholesterol and reducing my risk of another cardiovascular event?
2Since the trial is no longer enrolling new patients, are there other similar ongoing studies or approved treatment combinations I could explore, or would my doctor recommend simply pursuing this type of combination therapy outside of a trial setting?
3The trial is listed as Phase NA, which can sometimes mean it's more of an observational or registry-style study — can my doctor explain what that means for how much is already known about the safety and effectiveness of this drug combination in people who've just had a PCI?
4The trial is focused on preventing future cardiovascular events after an acute coronary syndrome — how does my doctor assess my personal risk level, and would a PCSK9 inhibitor added to my current statin actually be expected to meaningfully lower that risk for someone in my situation?
5What are the potential side effects or monitoring requirements I should know about when combining a PCSK9 inhibitor with high-intensity statin therapy, and how would that fit into my current treatment schedule and follow-up care?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Cardiovascular events
Timeframe: 12 months after randomization
Trial details
NCT IDNCT05457582
SponsorNanjing First Hospital, Nanjing Medical University