An interventional study of PCSK9 inhibitor and Statin+ezetimibe in Acute Myocardial Infarction, sponsored by Yun Dai Chen. Not yet recruiting at 2 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-03.
Sponsored by Yun Dai Chen · Not applicable, Interventional, and Treatment
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Among 195 studies in Myocardial Infarction with a site in China — 63 open to participants now, 72 under way, 7 of them phase 3. Myocardial Infarction · China.
Among the 195 studies in Myocardial Infarction with a site in China, this one is the 59th largest by planned enrollment of the 106 interventional ones that give a count, is one of 19 that started in 2025, is one of 44 with no phase, reaches primary completion later than 27 of the 71 other live ones, and was the 136th registered.
2,272 studies on the registry are indexed under Myocardial Infarction; 373 are open to participants now.
Browse Myocardial Infarction studies →63 of the 195 studies in Myocardial Infarction with a site in China are open now. Recruiting first, the newest first:
Shanghai Zhongshan Hospital · Sites in China
Ages 18+
Beijing Hospital · Sites in China
Ages 30–75
Peking University Third Hospital · Sites in China
Ages 18–80 · Healthy volunteers
Shanghai Zhongshan Hospital · Sites in China
Ages 18–75
Beijing Anzhen Hospital · Sites in China
Ages 18–80
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 257 Myocardial Infarction studies recruiting now, 173 (67%) set no upper age limit and 26 (10%) stop at 75 or younger; 17 take children under 18; 28 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
195 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 5 · Phase 2 9 · Phase 3 21 · Phase 4 32
First in 1999; this study’s year is marked. 19 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 300 is above the median of 150 across 1,315 interventional studies indexed under Myocardial Infarction.
Median enrollment 364 across the 106 interventional studies, 1,000 across the 89 observational. Of the 74 that completed or were terminated, 8 (11%) have results posted.
This tab as a report to print or save as PDF → With an account.
31 of 195 have an industry lead sponsor. The 10 most frequent:
Yun Dai Chen is the lead sponsor of 5 studies on the registry; 3 are open to participants now.
Yun Dai Chen has 1 study filed under Myocardial Infarction — fewer than ten, so there is no comparison to draw.
21 of the studies in Myocardial Infarction with a site in China that are under way reach primary completion within a year, 4 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07381803Phase 3Second Affiliated Hospital, Zhejiang University, School of MedicineThe Impact of Fexofenadine Hydrochloride on the Prognosis of Patients Post-Acute Myocardial Infarction | 2026-12 |
| NCT06118281Phase 3Novo Nordisk A/SARTEMIS - A Research Study to Look at How Ziltivekimab Works Compared to Placebo in People With a Heart Attack | 2027-01-29 |
| NCT07320625Phase 3Shanghai Zhongshan HospitalEfficacy of Montelukast on STEMl Patients | 2027-02-01 |
| NCT04957719Phase 3Viatris Innovation GmbHSelatogrel Outcome Study in Suspected Acute Myocardial Infarction | 2027-07 |
| NCT05891145Yangzhou UniversityRemimazolam for Postoperative Atrial Fibrillation | 2026-12 |
Add all 21 to your calendar (.ics) → With an account.
Among the 195 studies in Myocardial Infarction with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This study is planned to start on January 2024.
The goal of this clinical trial is to learn whether the perioperative administration (within 24 hours before or after primary PCI) of PCSK9 inhibitors can ameliorate plaque progression and adverse outcomes in patients with acute myocardial infarction (AMI). The main questions it aims to answer are:
Can perioperative PCSK9 inhibition improve the plaque stability and inflammation of perivascular adipose tissue (index of plaque attenuation（IPA ）and perivascular fat attenuation index（FAI）) of non-target lesions? Researchers will compare PCSK9 inhibitors with statin plus ezetimibe therapy to evaluate the potential of PCSK9 inhibitors in mitigating the progression of non-target lesion plaques and reducing adverse cardiovascular events in patients with AMI.
Participants will:
Take PCSK9 inhibitors every two weeks or daily statin plus ezetimibe therapy. Conduct a follow-up examination with optical coherence tomography (OCT) or coronary computed tomography angiography (CTA) after 12 months.
Record the occurrence of major adverse cardiovascular events.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
In this group, patients will receive PCSK9 inhibitor treatment
Drug: PCSK9 inhibitor · Behavioral: Blood lipid levels meet the recommended guidelines
In this group, patients will receive statin and ezetimibe treatment
Drug: Statin+ezetimibe · Behavioral: Blood lipid levels don't meet the recommended guidelines
The patient used Trastuzumab 150mg within 24 hours before or after PCI, and then every two weeks for 12 months
Drug pages: Statins · Ezetimibe
The patient used statins and ezetimibe within 24 hours before or after PCI, and then once a day for 12 months
Early use of intensified lipid-lowering therapy during hospitalization led to a rapid decrease in blood lipids and met the recommended guidelines.
The patient did not receive intensified lipid-lowering treatment during hospitalization or did not meet the recommended guidelines for blood lipids
Changes in Index of Plaque Attenuation (IPA) measured by OCT for non-culprit lesions at baseline and 12 months of follow-up.
IPA is a quantitative analysis tool based on OCT technology to evaluate plaque stability.
Time frame: 12 months
Changes in pericoronary artery fat attenuation index (FAI) measured by CCTA for non-culprit lesions at baseline and 12 months of follow-up
FAI is a quantitative indicator of inflammation in perivascular adipose tissue measured by CCTA.
Time frame: 12 months
Progress of target lesion plaques
To assess plaque progression, OCT evaluation will include fiber cap thickness, lipid core amplitude, minimum lumen area, and minimum lumen diameter. CCTA evaluation will include CAD-RADS grade , plaque volume, plaque properties, calcification score, epicardial fat volume and plaque attenuation. Notes: CAD-RADS indicates Coronary Artery Disease-Reporting and Data System, which range from 0 to 5. The higher CAD-RADS grade, the more severe of the coronary stenosis.
Time frame: 12 months
The overall incidence of the first major adverse cardiovascular events (MACEs) within 12 months in different treatment groups
MACEs was defined as the composite of myocardial infarction, ischemic stroke, cardiovascular death and coronary revascularization
Time frame: 12 months
The proportion of LDLC at each visit node that meets the recommended guidelines and the changes compared to baseline
Time frame: 1week；1months；3 months； 6 months; 9 months; 12 months
Changes in inflammatory factors (interleukin 6, C reaction protein) at each visit node compared to baseline
Time frame: 1week；1months；3 months； 6 months; 9 months; 12 months
Start is estimated for Apr 2025; primary completion for Dec 2026, 20 months later.
Of 322 non-industry interventional studies with no phase under Myocardial Infarction, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 58. This study's planned 20 months is below that.
Counting every sponsor, half of 355 studies reached it within 34 months; a quarter within 15 and three quarters within 57.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: PCSK9 Inhibitor
Yun Dai Chen