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| Name | Class |
|---|---|
| The First Affiliated Hospital with Nanjing Medical University | OTHER |
| Beijing Anzhen Hospital | OTHER |
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This is a multi-center, randomized controlled study to investigate whether early offering PCSK9 inhibitor can protect against negative inflammatory response and organ dysfunction after coronary artery bypass grafting (CABG). Subjects with myocardial ischaemic syndromes (MIS) will be enrolled in this study after consent information. After randomization, the control group will receive standard therapy, while the experiment group will receive first PCSK9 inhibitor before CABG, then twice a month until 3 months later. Six month after CABG, CRP will be used to evaluate inflammation, and echocardiography and coronary CTA will be used to evaluate cardiovascular function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PCSK9 inhibitor | Experimental | the experiment group will receive first PCSK9 inhibitor before CABG, then twice a month until 3 months later |
|
| Statin | Sham Comparator | the control group will receive standard statin therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PCSK9 inhibitor | Drug | the experiment group will receive first PCSK9 inhibitor before CABG, then twice a month until 3 months later. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Major Adverse Cardiovascular and Cerebrovascular Events | Major Adverse Cardiovascular and Cerebrovascular Events include cardiac death, reinfarction, emergency coronary revascularization and stroke | 6 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| C-reactive protein | Peripheral blood C-reactive protein | 6 months after surgery |
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Inclusion Criteria:
Exclusion Criteria:
i. Pregnant and lactating women ii. During the study period and within 3 months of receiving the last dose of the study drug, women with fertility intentions and men unwilling to use effective contraceptive methods iii. Have used PCSK9 inhibitors within 3 months before enrollment, or have a history of severe allergic reactions to PCSK9 inhibitors iv. Severe infections requiring intravenous antibiotics v. HIV-positive or history of acquired immunodeficiency syndrome (AIDS) vi. With cognitive impairment or psychiatric illnesses
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hong Liu, MD | Contact | 18801281613 | dr.hongliu@foxmail.com | |
| Lu-yao Ma, MD | Contact | 02568303101 | maluyao@jsph.org.cn |
| Name | Affiliation | Role |
|---|---|---|
| Lu-yao Ma, MD | The First Affiliated Hospital with Nanjing Medical University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Anzhen Hospital, Capital Medical University | Beijing | Beijing Municipality | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33197560 | Result | Oyama K, Furtado RHM, Fagundes A Jr, Zelniker TA, Tang M, Kuder J, Murphy SA, Hamer A, Wang H, Keech AC, Giugliano RP, Sabatine MS, Bergmark BA. Effect of Evolocumab on Complex Coronary Disease Requiring Revascularization. J Am Coll Cardiol. 2021 Jan 26;77(3):259-267. doi: 10.1016/j.jacc.2020.11.011. Epub 2020 Nov 13. | |
| 35606883 | Result |
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| Statin | Drug | the control group will receive standard statin therapy. |
|
| The First Affiliated Hospital of Nanjing Medical University | Nanjing | Jiangsu | 210029 | China |
|
| Na HR, Kwon OS, Kang JK, Kim YH, Lim JY. Evolocumab administration prior to Coronary Artery Bypass Grafting in patients with multivessel coronary artery disease (EVOCABG): study protocol for a randomized controlled clinical trial. Trials. 2022 May 23;23(1):430. doi: 10.1186/s13063-022-06398-3. |
| 38337601 | Result | Nasso G, Larosa C, Bartolomucci F, Brigiani MS, Contegiacomo G, Demola MA, Vignaroli W, Tripoli A, Girasoli C, Lisco R, Trivigno M, Tunzi RM, Loizzo T, Hila D, Franchino R, Amodeo V, Ventra S, Diaferia G, Schinco G, Agro FE, Zingaro M, Rosa I, Lorusso R, Del Prete A, Santarpino G, Speziale G. Safety and Efficacy of PCSK9 Inhibitors in Patients with Acute Coronary Syndrome Who Underwent Coronary Artery Bypass Grafts: A Comparative Retrospective Analysis. J Clin Med. 2024 Feb 4;13(3):907. doi: 10.3390/jcm13030907. |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D019161 | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
| ID | Term |
|---|---|
| D000924 | Anticholesteremic Agents |
| D000960 | Hypolipidemic Agents |
| D000963 | Antimetabolites |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D004791 | Enzyme Inhibitors |
| D057847 | Lipid Regulating Agents |
| D045506 | Therapeutic Uses |
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