Intensive Cholesterol-Lowering Within 24 Hours of PCI Perioperative Period (NCT07290699) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Intensive Cholesterol-Lowering Within 24 Hours of PCI Perioperative Period
2,442 participantsStarted 2026-01-01
Plain-language summary
This project team is conducting a multicenter randomized controlled study, aiming to administer PCSK9 inhibitors subcutaneously as early as possible within 24 hours during the perioperative period of AMI (included \<24h STEMI and NSTEMI), and subsequently once every 12 weeks for a total of 6 months, followed by step-down therapy according to guideline-recommended lipid-lowering strategies based on LDL-C target levels. The study will evaluate changes in blood lipids and inflammatory markers during hospitalization and at follow-up visits at 1, 3, 6, 9, and 12 months, as well as the incidence of MACE events. Safety will also be assessed, including liver enzymes, kidney function, and other adverse reactions. Compared with conventional treatment, the study will test efficacy and ultimately clarify that early combined use of PCSK9 inhibitors during the perioperative period of AMI patients can safely and effectively reduce LDL-C, control systemic inflammatory responses, and improve the incidence of MACE events.
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:
* Age ≥18 years;
* Meet the definition of acute myocardial infarction according to the "2019 Guidelines for the Diagnosis and Treatment of Acute ST-Segment Elevation Myocardial Infarction", including STEMI and NSTEMI with onset \<24 hours;
* Able to understand and voluntarily sign the informed consent form.
Exclusion Criteria:
* Severe mental disorders that prevent the expression of consent;
* Severe heart failure (Killip class III or IV) or cardiogenic shock;
* According to the investigator's judgment, the presence of significant other abnormal signs, laboratory findings, or clinical conditions (such as tumors, shock, liver or kidney failure, etc.) that make participation unsuitable;
* Investigator's judgment that the subject cannot complete long-term follow-up;
* Intolerance to statins or cholesterol absorption inhibitors;
* Intolerance to injections;
* Subjects who received PCSK9 inhibitor treatment or participated in other PCSK9 inhibitor studies within 4 months before randomization;
* Pregnant women.
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 involves starting intensive cholesterol-lowering treatment within 24 hours of a PCI procedure — given my specific type of heart attack, does my care team think that timing window is realistic and appropriate for my situation?
2Since this is a Phase 4 trial, the drugs being tested are already approved, but what does my doctor think the remaining unknowns are about using them intensively right around the time of PCI that this study is trying to answer?
3The trial is not yet recruiting, so if I'm interested, how long might it be before it opens and would waiting potentially affect my treatment or recovery?
4The trial is measuring MACE — major adverse cardiovascular events — as its main outcome, so what does my doctor think is my current personal risk of those events, and how does that affect whether joining this study might or might not make sense for me?
5Is there a standard cholesterol-lowering approach my care team would already recommend after my heart attack, and how does that compare to what this trial is testing, so I understand what I might be doing differently if I eventually enrolled?
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
MACE
Timeframe: From enrollment to the end of treatment at 12 months
Trial details
NCT IDNCT07290699
SponsorSecond Affiliated Hospital of Nanchang University