Ignite Creation Date:
2025-12-24 @ 10:21 PM
Ignite Modification Date:
2025-12-25 @ 7:53 PM
Study NCT ID:
NCT06134635
Status:
UNKNOWN
Last Update Posted:
2023-11-18
First Post:
2023-10-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Short-term Effect of PCSK9 Inhibitor in Patients With Acute Ischemic Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}], 'ancestors': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019161', 'term': 'Hydroxymethylglutaryl-CoA Reductase Inhibitors'}, {'id': 'C577155', 'term': 'evolocumab'}], 'ancestors': [{'id': 'D000924', 'term': 'Anticholesteremic Agents'}, {'id': 'D000960', 'term': 'Hypolipidemic Agents'}, {'id': 'D000963', 'term': 'Antimetabolites'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D004791', 'term': 'Enzyme Inhibitors'}, {'id': 'D057847', 'term': 'Lipid Regulating Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-14', 'studyFirstSubmitDate': '2023-10-24', 'studyFirstSubmitQcDate': '2023-11-14', 'lastUpdatePostDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'LDL-C target achievement rate on Day 5, Month 3', 'timeFrame': 'Day 5, Month 3', 'description': 'LDL-C target achievement rate= Number of patients who achieved the LDL-C target level/ Total number of follow-up patients'}], 'secondaryOutcomes': [{'measure': 'Percentage change in LDL-C level on Day 1, Day 3, Day 5, and Month 3', 'timeFrame': 'Day 1, Day 3, Day 5, Month 3', 'description': 'Percentage change in LDL-C level= (follow-up LDL-C level - baseline LDL-C level)/ baseline LDL-C level'}, {'measure': 'Percentage change in HDL-C level on Day 1, Day 3, Day 5, and Month 3', 'timeFrame': 'Day 1, Day 3, Day 5, Month 3', 'description': 'Percentage change in HDL-C level= (follow-up HDL-C level - baseline HDL-C level)/ baseline HDL-C level'}, {'measure': 'Percentage change in TC level on Day 1, Day 3, Day 5, and Month 3', 'timeFrame': 'Day 1, Day 3, Day 5, Month 3', 'description': 'Percentage change in TC level= (follow-up TC level - baseline TC level)/ baseline TC level'}, {'measure': 'Percentage change in TG level on Day 1, Day 3, Day 5, and Month 3', 'timeFrame': 'Day 1, Day 3, Day 5, Month 3', 'description': 'Percentage change in TG level= (follow-up TG level - baseline TG level)/ baseline TG level'}, {'measure': 'Percentage change in Apo AI level on Day 1, Day 3, Day 5, and Month 3', 'timeFrame': 'Day 1, Day 3, Day 5, Month 3', 'description': 'Percentage change in Apo AI level= (follow-up Apo AI level - baseline Apo AI level)/ baseline Apo AI level'}, {'measure': 'Percentage change in Apo B level on Day 1, Day 3, Day 5, and Month 3', 'timeFrame': 'Day 1, Day 3, Day 5, Month 3', 'description': 'Percentage change in Apo B level= (follow-up Apo B level - baseline Apo B level)/ baseline Apo B level'}, {'measure': 'Percentage change in hsCRP level on Day 1, Day 3, Day 5, and Month 3', 'timeFrame': 'Day 1, Day 3, Day 5, Month 3', 'description': 'Percentage change in hsCRP level= (follow-up hsCRP level - baseline hsCRP level)/ baseline hsCRP level'}, {'measure': 'Percentage change in IL-6 level on Day 1, Day 3, Day 5, and Month 3', 'timeFrame': 'Day 1, Day 3, Day 5, Month 3', 'description': 'Percentage change in IL-6 level= (follow-up IL-6 level - baseline IL-6 level)/ baseline IL-6 level'}, {'measure': 'Percentage of mRS≤2 on Month 3', 'timeFrame': 'Month 3', 'description': 'Percentage of mRS≤2= Number of patients with mRS≤2/ Total number of follow-up patients'}, {'measure': 'Incidence of major cardiovascular events on Month 3', 'timeFrame': 'Month 3', 'description': 'Major cardiovascular events: stroke, cardiovascular death, myocardial infarction, hospitalization for unstable angina, and coronary revascularization.'}, {'measure': 'Incidence of adverse events on Month 3', 'timeFrame': 'Month 3', 'description': 'Adverse events: injection site reaction, anaphylaxis, myopathy, abnormal liver function, new onset diabetes, cognitive impairment, and hemorrhagic cerebral infarction.'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acute Ischemic Stroke', 'Evolocumab', 'PCSK9 Inhibitor', 'Statins'], 'conditions': ['Acute Ischemic Stroke']}, 'descriptionModule': {'briefSummary': 'This is a prospective cohort study to investigate the early impact of evolocumab on patients with acute ischemic stroke (AIS) in China. Evolocumab, a proprotein convertase subtilisin/kexin taye 9 inhibitor, can significantly reduce low density lipoprotein cholesterol (LDL-C) levels and has a positive effect on improving cardiovascular events. However, existing studies have focused almost exclusively on the long-term effects of Evolocumab, and the early effects of Evolocumab on AIS patients remains unclear.', 'detailedDescription': 'Patients aged 18-80 years old admitted to the Department of Neurology, Xuanwu Hospital, Capital Medical University, with a definite diagnosis of acute ischemic stroke and receiving lipid-lowering therapy with statins with or without evolocumab will be included in this study. Participants will be divided into two groups according to the lipid-lowering therapy they used: 1) statin-alone group: the participants receive statins alone (atorvastatin 20mg qn or rosuvastatin 10mg qn or pivastatin 2mg qn) for lipid reduction, and 2) PCSK9-i group: the participants receive statins (atorvastatin 20mg qn or rosuvastatin 10mg qn or pivastatin 2mg qn) and evolocumab (140mg twice a month) for lipid reduction. Most importantly, the lipid-lowering therapy of participants will be decided only by clinicians not involved in the study, not by the investigators. The levels of blood lipid (TC, TG, HDL-C, LDL-C, Apo AI and Apo B) and inflammatory biomarkers (hsCRP and IL-6) of these participants at different time points (day 1, day 3, day 5, and month 3) will be recorded. The target level of LDL-C is the LDL-C reduction ≥50% from the baseline and LDL-C\\<1.4mmol/L (55mg/dL). In addition, the cardiovascular events and adverse drug reactions of these participants during follow-up will also be recorded. During the follow-up period (3 months), participants who changed their lipid-lowering regimen, including the type, dosage and frequency of statins and evolocumab, will be excluded from the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Acute ischemic stroke patients aged 18 to 80 years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with acute ischemic stroke;\n* Aged 18-80 years, gender unlimited;\n* The fasting LDL-C≥1.8mmol/L (70mg/dL);\n* Received lipid-lowering therapy with statins with or without evolocumab;\n* Premorbid mRS ≤ 2;\n* NIHSS ≤ 15;\n* Subjects participated in the study voluntarily and signed informed consent.\n\nExclusion Criteria:\n\n* Participants who changed their lipid-lowering regimen;\n* Participants allergic to PCSK9 inhibitors;\n* Participants treated with cholesterol ester transfer protein inhibitor within 12 months prior to enrollment;\n* LDL or plasma apheresis within 12 months prior to enrollment；\n* Last known left ventricular ejection fraction \\< 30%\n* Known hemorrhagic stroke at any time；\n* Severe renal dysfunction, defined as an estimated glomerular filtration rate (eGFR) \\< 20 mL/min/1.73m2 at final screening；\n* Active liver disease or hepatic dysfunction, defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \\> 3 times；\n* Pregnant or lactating women；\n* Severe, concomitant non-cardiovascular disease that is expected to reduce life expectancy to less than 3 years.'}, 'identificationModule': {'nctId': 'NCT06134635', 'briefTitle': 'Short-term Effect of PCSK9 Inhibitor in Patients With Acute Ischemic Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Xuanwu Hospital, Beijing'}, 'officialTitle': 'Short-term Effect of Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitor in Chinese Population With Acute Ischemic Stroke: the Singe-center Real-world Study', 'orgStudyIdInfo': {'id': 'RMeng'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Statin-alone group', 'description': 'The participants in statin-alone group receive statins alone for lipid reduction.', 'interventionNames': ['Drug: Statins']}, {'label': 'PCSK9-i group', 'description': 'The participants in PCSK9-i group receive statins and evolocumab for lipid reduction.', 'interventionNames': ['Drug: Statins', 'Drug: Evolocumab']}], 'interventions': [{'name': 'Statins', 'type': 'DRUG', 'otherNames': ['statin therapy'], 'description': 'Atorvastatin 20mg qn or rosuvastatin 10mg qn or pivastatin 2mg qn, oral', 'armGroupLabels': ['PCSK9-i group', 'Statin-alone group']}, {'name': 'Evolocumab', 'type': 'DRUG', 'otherNames': ['PCSK9-i'], 'description': 'Evolocumab 140mg twice a month, subcutaneous injection', 'armGroupLabels': ['PCSK9-i group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Meng Ran, PhD', 'role': 'CONTACT', 'email': 'victor65@126.com', 'phone': '+86-10-83199280'}], 'overallOfficials': [{'name': 'Meng Ran, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Xuanwu Hospital, Beijing'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xuanwu Hospital, Beijing', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}