Intensive Cholesterol-Lowering Within 24 Hours of PCI Perioperative Period
NCT ID: NCT07290699
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE4
2442 participants
INTERVENTIONAL
2026-01-01
2028-08-30
Brief Summary
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Detailed Description
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Randomization method: All eligible patients entering the respective groups will be randomly obtained a random number. The maximum follow-up period is 1 year. Safety evaluation includes monitoring all adverse events (AEs), serious adverse events (SAEs), as well as regular monitoring of vital signs and clinical laboratory tests.
Each center will screen hospitalized AMI patients according to inclusion and exclusion criteria. Baseline data will be entered into the CRF form for the first time, including basic patient information, admission details, laboratory and instrument examinations, surgical procedure details, postoperative medications, and occurrence of adverse events during hospitalization. After discharge, follow-up visits will be conducted at 1 month, 3 months, 6 months, 9 months, and 1 year, inquiring about current health status and medication usage, and recording the occurrence of endpoint events and lipid levels in the follow-up section of the CRF.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Intervention Group
Intensive lipid-lowering within 24 hours during the perioperative period of AMI (standard treatment + PCSK9 inhibitors)；Recaticimab 450 mg once every 12 weeks
Recaticimab
Recaticimab 450 mg once every 12 weeks. Group 1 (G1, experimental group): Intensive lipid-lowering therapy within 24 hours during the perioperative period of AMI (standard treatment + PCSK9 inhibitors), treatment for 6 months; Group 2 (G2, control group): standard treatment (antiplatelet drugs, 20 mg atorvastatin/10 mg rosuvastatin ± cholesterol absorption inhibitors). After 6 months, both groups continued with guideline-recommended conventional treatment.
Control group
Standard treatment (antiplatelet drugs, 20mg atorvastatin / 10mg rosuvastatin ± cholesterol absorption inhibitors)
No interventions assigned to this group
Interventions
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Recaticimab
Recaticimab 450 mg once every 12 weeks. Group 1 (G1, experimental group): Intensive lipid-lowering therapy within 24 hours during the perioperative period of AMI (standard treatment + PCSK9 inhibitors), treatment for 6 months; Group 2 (G2, control group): standard treatment (antiplatelet drugs, 20 mg atorvastatin/10 mg rosuvastatin ± cholesterol absorption inhibitors). After 6 months, both groups continued with guideline-recommended conventional treatment.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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First Affiliated Hospital of Gannan Medical University
OTHER
Jiujiang No.1 People's Hospital
OTHER
First People's Hospital of FuZhou
OTHER
Yueyang Central Hospital
OTHER
The First People's Hospital of Changde City
OTHER
ZhuZhou Central Hospital
OTHER
Xiangtan Central Hospital
OTHER
Loudi Central Hospital
OTHER
Second Affiliated Hospital of Nanchang University
OTHER
Responsible Party
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Central Contacts
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References
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Other Identifiers
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IIT-I-2025-098
Identifier Type: -
Identifier Source: org_study_id