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The goal of this clinical trial is to learn if drug tafolecimab works to treat participants with acute myocardial infarction (AMI) scheduled for primary percutaneous coronary intervention (PCI). It will also learn about the safety of drug tafolecimab. The main questions it aims to answer are:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PCSK9 inhibitor (PCSK9i) group | Experimental | Participants receive PCSK9i tafolecimab and standard of care (SoC) of acute myocardial infarction |
|
| Control group | No Intervention | Participants receive SoC of acute myocardial infarction |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tafolecimab | Drug | 450mg of tafolecimab (150mg each one) was injected subcutaneously before primary PCI and then 150mg subcutaneously injected every half a month till totally 12 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of major adverse cardiovascular events (MACEs) | MACEs including cardiovascular death, nonfatal myocardial infarction, unplanned ischemia-driven revascularization, nonfatal stroke, hospitalization for heart failure | From enrollment to 1 year after primary percutaneous coronary intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with coronary microvascular dysfunction (CMD) | Measurement of coronary angiography-derived microcirculation resistance index (caIMR) | Immediately after primary percutaneous coronary intervention |
| Number of participants with coronary microvascular dysfunction (CMD) |
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Inclusion Criteria:
Adults 18-75 years old
AMI diagnosed according to the latest guidelines, including ST-segment elevation myocardial infarction (STEMI) and non-ST-segment elevation myocardial infarction (NSTEMI)
Regardless of baseline LDL-C levels
Participants voluntarily took part in this study and signed informed consent
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuan Lu, M.D. and Ph.D. | Contact | +8613952110901 | drluyuan329@163.com | |
| Yiwen Wang, M.D. | Contact | +8615094343962 | wangyiwen@xzhmu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Yong Huo, M.D. and Ph.D. | Peking University First Hospital | Study Chair |
| Yuan Lu, M.D. and Ph.D. | The Affiliated Hospital of Xuzhou Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taihe County People's Hospital | Fuyang | Anhui | China |
Participants do not consent to the data sharing about themselves. IPD involves privacy and ethical issues.
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Infarct size (IS), intramyocardial hemorrhage (IMH) and microvascular obstruction (MVO) assessed by cardiac magnetic resonance |
| 3-7 days after primary percutaneous coronary intervention |
| Concentration of low density lipoprotein cholesterol (LDL-C) | The measurement of LDL-C level and number of participants reaching the target according to current guidelines | Both 1 month and 1 year after primary percutaneous coronary intervention |
| Rate of malignant arrhythmia | These include sudden cardiac death (SCD), sudden death survival (aborted SCD), appropriate implantable cardioverter defibrillator (ICD) interventions, and persistent ventricular arrhythmias monitored by a 72-hour holter electrocardiogram. | 1 month after primary percutaneous coronary intervention |
| The Fifth People's Hospital of Huai'an City | Huai'an | Jiangsu | China |
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| Lianyungang Municipal Dongfang Hospital | Lianyungang | Jiangsu | China |
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| Jiangsu Provincial Hospital of Traditional Chinese Medicine | Nanjing | Jiangsu | China |
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| Jiangsu Provincial People's Hospital (The First Affiliated Hospital of Nanjing Medical University) | Nanjing | Jiangsu | China |
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| The Fourth Affiliated Hospital of Nanjing Medical University | Nanjing | Jiangsu | China |
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| Suqian Hospital of Jiangsu Provincial People's Hospital | Suqian | Jiangsu | China |
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| The affiliated hospital of Xuzhou Medical University | Xuzhou | Jiangsu | 221006 | China |
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| Suining County People's Hospital | Xuzhou | Jiangsu | China |
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| Xuzhou Central Hospital | Xuzhou | Jiangsu | China |
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| Xuzhou Mining Group General Hospital | Xuzhou | Jiangsu | China |
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| Peking University First Hospital | Beijing | 100000 | China |
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| Shanghai Tenth People's Hospital | Shanghai | China |
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