Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2026-01-01 @ 11:45 AM
Study NCT ID:
NCT06853535
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-03-03
First Post:
2025-02-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Precision Antiplatelet Therapy Guided by Platelet Aggregation Function 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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5138}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-28', 'studyFirstSubmitDate': '2025-02-18', 'studyFirstSubmitQcDate': '2025-02-28', 'lastUpdatePostDateStruct': {'date': '2025-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recurrent stroke (including ischemic and hemorrhagic stroke) within 90 days', 'timeFrame': 'within 90 days'}], 'secondaryOutcomes': [{'measure': 'Recurrent ischemic stroke', 'timeFrame': 'On the 7th day, at 30 days, and within 1 year'}, {'measure': 'New-onset vascular events', 'timeFrame': 'On the 7th day, at 30 days, at 90 days and within 1 year.', 'description': 'Including cardiovascular and cerebrovascular strokes, myocardial infarctions, and vascular deaths.'}, {'measure': 'Modified Rankin Scale (mRS) score', 'timeFrame': 'at 30 days, 90 days, and 1 year', 'description': 'The score range of the scale is from 0 to 6. The higher the score, the worse the outcome.'}, {'measure': 'Recurrent stroke', 'timeFrame': 'On the 7th day, the 30th day, the 90th day and within one year.'}, {'measure': 'Worsening of nerve damage (an increase in the NIHSS score by ≥ 4 points compared to the baseline)', 'timeFrame': 'At the 24th hour and on the 7th day'}, {'measure': 'Quality of life at day 90 [assessed by the EuroQol - 5 dimension (EQ - 5D) questionnaire]', 'timeFrame': 'at 90 days', 'description': 'It is usually represented by a value between 0 and 1, where 1 represents perfect health, 0 represents death, and the intermediate values reflect different degrees of health status.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Ischemic Stroke', 'Clopidogrel Resistance']}, 'referencesModule': {'references': [{'pmid': '32587571', 'type': 'BACKGROUND', 'citation': 'Yang Y, Chen W, Pan Y, Yan H, Meng X, Liu L, Wang Y, Wang Y. Ticagrelor Is Superior to Clopidogrel in Inhibiting Platelet Reactivity in Patients With Minor Stroke or TIA. Front Neurol. 2020 Jun 10;11:534. doi: 10.3389/fneur.2020.00534. eCollection 2020.'}, {'pmid': '10440417', 'type': 'BACKGROUND', 'citation': 'Savcic M, Hauert J, Bachmann F, Wyld PJ, Geudelin B, Cariou R. Clopidogrel loading dose regimens: kinetic profile of pharmacodynamic response in healthy subjects. Semin Thromb Hemost. 1999;25 Suppl 2:15-9.'}, {'pmid': '31171523', 'type': 'BACKGROUND', 'citation': 'Wang Y, Chen W, Lin Y, Meng X, Chen G, Wang Z, Wu J, Wang D, Li J, Cao Y, Xu Y, Zhang G, Li X, Pan Y, Li H, Zhao X, Liu L, Lin J, Dong K, Jing J, Johnston SC, Wang D, Wang Y; PRINCE Protocol Steering Group. Ticagrelor plus aspirin versus clopidogrel plus aspirin for platelet reactivity in patients with minor stroke or transient ischaemic attack: open label, blinded endpoint, randomised controlled phase II trial. BMJ. 2019 Jun 6;365:l2211. doi: 10.1136/bmj.l2211.'}, {'pmid': '25678901', 'type': 'BACKGROUND', 'citation': 'Zhu HC, Li Y, Guan SY, Li J, Wang XZ, Jing QM, Wang ZL, Han YL. Efficacy and safety of individually tailored antiplatelet therapy in patients with acute coronary syndrome after coronary stenting: a single center, randomized, feasibility study. J Geriatr Cardiol. 2015 Jan;12(1):23-9. doi: 10.11909/j.issn.1671-5411.2015.01.003.'}, {'pmid': '27581531', 'type': 'BACKGROUND', 'citation': 'Cayla G, Cuisset T, Silvain J, Leclercq F, Manzo-Silberman S, Saint-Etienne C, Delarche N, Bellemain-Appaix A, Range G, El Mahmoud R, Carrie D, Belle L, Souteyrand G, Aubry P, Sabouret P, du Fretay XH, Beygui F, Bonnet JL, Lattuca B, Pouillot C, Varenne O, Boueri Z, Van Belle E, Henry P, Motreff P, Elhadad S, Salem JE, Abtan J, Rousseau H, Collet JP, Vicaut E, Montalescot G; ANTARCTIC investigators. Platelet function monitoring to adjust antiplatelet therapy in elderly patients stented for an acute coronary syndrome (ANTARCTIC): an open-label, blinded-endpoint, randomised controlled superiority trial. Lancet. 2016 Oct 22;388(10055):2015-2022. doi: 10.1016/S0140-6736(16)31323-X. Epub 2016 Aug 28.'}, {'pmid': '33865495', 'type': 'BACKGROUND', 'citation': "Galli M, Benenati S, Capodanno D, Franchi F, Rollini F, D'Amario D, Porto I, Angiolillo DJ. Guided versus standard antiplatelet therapy in patients undergoing percutaneous coronary intervention: a systematic review and meta-analysis. Lancet. 2021 Apr 17;397(10283):1470-1483. doi: 10.1016/S0140-6736(21)00533-X."}, {'pmid': '31603191', 'type': 'BACKGROUND', 'citation': 'Zheng YY, Wu TT, Yang Y, Hou XG, Gao Y, Chen Y, Yang YN, Li XM, Ma X, Ma YT, Xie X. Personalized antiplatelet therapy guided by a novel detection of platelet aggregation function in stable coronary artery disease patients undergoing percutaneous coronary intervention: a randomized controlled clinical trial. Eur Heart J Cardiovasc Pharmacother. 2020 Jul 1;6(4):211-221. doi: 10.1093/ehjcvp/pvz059.'}, {'pmid': '33686963', 'type': 'BACKGROUND', 'citation': 'Ma L, Chen W, Pan Y, Yan H, Li H, Meng X, Wang Y, Wang Y. Comparison of VerifyNow, thromboelastography, and PL-12 in patients with minor ischemic stroke or transient ischemic attack. Aging (Albany NY). 2021 Mar 3;13(6):8396-8407. doi: 10.18632/aging.202650. Epub 2021 Mar 3.'}, {'pmid': '33749312', 'type': 'BACKGROUND', 'citation': 'Yue C, Lin Z, Lu C, Chen H. Efficacy of Monitoring Platelet Function by an Automated PL-12 Analyzer During the Treatment of Acute Cerebral Infarction With Antiplatelet Medicine. Clin Appl Thromb Hemost. 2021 Jan-Dec;27:10760296211001119. doi: 10.1177/10760296211001119.'}, {'pmid': '34708996', 'type': 'BACKGROUND', 'citation': 'Wang Y, Meng X, Wang A, Xie X, Pan Y, Johnston SC, Li H, Bath PM, Dong Q, Xu A, Jing J, Lin J, Niu S, Wang Y, Zhao X, Li Z, Jiang Y, Li W, Liu L, Xu J, Chang L, Wang L, Zhuang X, Zhao J, Feng Y, Man H, Li G, Wang B; CHANCE-2 Investigators. Ticagrelor versus Clopidogrel in CYP2C19 Loss-of-Function Carriers with Stroke or TIA. N Engl J Med. 2021 Dec 30;385(27):2520-2530. doi: 10.1056/NEJMoa2111749. Epub 2021 Oct 28.'}, {'pmid': '26935114', 'type': 'BACKGROUND', 'citation': 'Yi X, Lin J, Zhou Q, Wu L, Cheng W, Wang C. Clopidogrel Resistance Increases Rate of Recurrent Stroke and Other Vascular Events in Chinese Population. J Stroke Cerebrovasc Dis. 2016 May;25(5):1222-1228. doi: 10.1016/j.jstrokecerebrovasdis.2016.02.013. Epub 2016 Feb 28.'}, {'pmid': '38518890', 'type': 'BACKGROUND', 'citation': 'Wu Y, Shen H, Cai B, Chen C, Yin Q, Zhao Y, Zhou G. Factors associated with clopidogrel resistance and clinical outcomes in ischemic cerebrovascular disease: A retrospective study. J Stroke Cerebrovasc Dis. 2024 Jun;33(6):107684. doi: 10.1016/j.jstrokecerebrovasdis.2024.107684. Epub 2024 Mar 20.'}, {'pmid': '28228483', 'type': 'BACKGROUND', 'citation': 'Estevez B, Du X. New Concepts and Mechanisms of Platelet Activation Signaling. Physiology (Bethesda). 2017 Mar;32(2):162-177. doi: 10.1152/physiol.00020.2016.'}, {'pmid': '28230176', 'type': 'BACKGROUND', 'citation': 'Franchi F, Rollini F, Angiolillo DJ. Antithrombotic therapy for patients with STEMI undergoing primary PCI. Nat Rev Cardiol. 2017 Jun;14(6):361-379. doi: 10.1038/nrcardio.2017.18. Epub 2017 Feb 23.'}, {'pmid': '26149036', 'type': 'BACKGROUND', 'citation': 'Mastenbroek TG, van Geffen JP, Heemskerk JW, Cosemans JM. Acute and persistent platelet and coagulant activities in atherothrombosis. J Thromb Haemost. 2015 Jun;13 Suppl 1:S272-80. doi: 10.1111/jth.12972.'}, {'pmid': '38157499', 'type': 'BACKGROUND', 'citation': 'Gao Y, Chen W, Pan Y, Jing J, Wang C, Johnston SC, Amarenco P, Bath PM, Jiang L, Yang Y, Wang T, Han S, Meng X, Lin J, Zhao X, Liu L, Zhao J, Li Y, Zang Y, Zhang S, Yang H, Yang J, Wang Y, Li D, Wang Y, Liu D, Kang G, Wang Y, Wang Y; INSPIRES Investigators. Dual Antiplatelet Treatment up to 72 Hours after Ischemic Stroke. N Engl J Med. 2023 Dec 28;389(26):2413-2424. doi: 10.1056/NEJMoa2309137.'}, {'pmid': '23803136', 'type': 'BACKGROUND', 'citation': 'Wang Y, Wang Y, Zhao X, Liu L, Wang D, Wang C, Wang C, Li H, Meng X, Cui L, Jia J, Dong Q, Xu A, Zeng J, Li Y, Wang Z, Xia H, Johnston SC; CHANCE Investigators. Clopidogrel with aspirin in acute minor stroke or transient ischemic attack. N Engl J Med. 2013 Jul 4;369(1):11-9. doi: 10.1056/NEJMoa1215340. Epub 2013 Jun 26.'}, {'pmid': '22052510', 'type': 'BACKGROUND', 'citation': 'Liu L, Wang D, Wong KS, Wang Y. Stroke and stroke care in China: huge burden, significant workload, and a national priority. Stroke. 2011 Dec;42(12):3651-4. doi: 10.1161/STROKEAHA.111.635755. Epub 2011 Nov 3.'}, {'pmid': '28052979', 'type': 'BACKGROUND', 'citation': 'Wang W, Jiang B, Sun H, Ru X, Sun D, Wang L, Wang L, Jiang Y, Li Y, Wang Y, Chen Z, Wu S, Zhang Y, Wang D, Wang Y, Feigin VL; NESS-China Investigators. Prevalence, Incidence, and Mortality of Stroke in China: Results from a Nationwide Population-Based Survey of 480 687 Adults. Circulation. 2017 Feb 21;135(8):759-771. doi: 10.1161/CIRCULATIONAHA.116.025250. Epub 2017 Jan 4.'}, {'pmid': '36862407', 'type': 'BACKGROUND', 'citation': 'Tu WJ, Zhao Z, Yin P, Cao L, Zeng J, Chen H, Fan D, Fang Q, Gao P, Gu Y, Tan G, Han J, He L, Hu B, Hua Y, Kang D, Li H, Liu J, Liu Y, Lou M, Luo B, Pan S, Peng B, Ren L, Wang L, Wu J, Xu Y, Xu Y, Yang Y, Zhang M, Zhang S, Zhu L, Zhu Y, Li Z, Chu L, An X, Wang L, Yin M, Li M, Yin L, Yan W, Li C, Tang J, Zhou M, Wang L. Estimated Burden of Stroke in China in 2020. JAMA Netw Open. 2023 Mar 1;6(3):e231455. doi: 10.1001/jamanetworkopen.2023.1455.'}, {'pmid': '37468952', 'type': 'BACKGROUND', 'citation': 'Tu WJ, Wang LD; Special Writing Group of China Stroke Surveillance Report. China stroke surveillance report 2021. Mil Med Res. 2023 Jul 19;10(1):33. doi: 10.1186/s40779-023-00463-x.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this clinical trial is to evaluate the efficacy and safety of platelet aggregation function - guided precision anti - platelet therapy in patients with acute cerebral infarction. The main question it aims to answer is: among the cerebral infarction patients with possible clopidogrel resistance detected by platelet aggregation function tests, what is the efficacy and safety of using ticagrelor to replace the clopidogrel treatment regimen.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 1.Aged between 18 and 80 years old; 2.Diagnosed with non-cardiogenic ischemic stroke or TIA according to WHO criteria, confirmed by cranial CT or MRI to exclude hemorrhagic stroke.; 3.This stroke onset is ≤ 48 hours; (The duration of onset is defined as the time from the last time the patient was seen normal to the time of taking 300 mg of clopidogrel and 100 - 300 mg of aspirin in combination) 4.The NIHSS score is ≤ 5 points before randomization, or for TIA patients, the ABCD2 score is ≥ 4 points; 5.Within 48 hours after the patient's onset, 5 - 20 hours after receiving anti - platelet therapy with a combination of 300 mg of clopidogrel and 100 - 300 mg of aspirin, the measured MARADP is ≥ 35%; 6.The patient or their family member signs a written informed consent form.\n\nExclusion Criteria:\n\n* 1.Imaging examination indicates hemorrhagic stroke or hemorrhagic transformation.\n\n 2.There is a history of diseases such as atrial fibrillation, left ventricular thrombosis, cardiomyopathy or valvular disease.\n\n 3.There are the following congenital heart diseases: patent foramen ovale, ventricular septal defect, atrial septal defect and tetralogy of Fallot.\n\n 4.Other P2Y12 receptor inhibitors (e.g., ticagrelor, prasugrel) except clopidogrel have been taken within 7 days.\n\n 5.There is a history of gastrointestinal bleeding, intracranial bleeding, recent massive bleeding or blood transfusion (excluding a small amount of hemoptysis and a small amount of abnormal vaginal bleeding), as well as a history of other hemorrhagic diseases caused by abnormal blood coagulation function (such as purpura, etc.).\n\n 6.There are contraindications or intolerance to anti - platelet drugs. 7.Patients with severe cardiac, pulmonary, hepatic and renal insufficiency, and those with serious comorbidities (e.g., cancer, chronic obstructive pulmonary disease, severe dementia, severe heart failure).\n\n 8.Those with poor compliance who cannot cooperate to meet the requirements of the study."}, 'identificationModule': {'nctId': 'NCT06853535', 'acronym': 'PATH STROKE C', 'briefTitle': 'Precision Antiplatelet Therapy Guided by Platelet Aggregation Function in Patients with Acute Ischemic STROKE', 'organization': {'class': 'OTHER', 'fullName': "Sichuan Provincial People's Hospital"}, 'officialTitle': 'Precision Antiplatelet Therapy Guided by Platelet Aggregation Function in Patients with Acute Ischemic STROKE', 'orgStudyIdInfo': {'id': 'IITLX2025007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'The ticagrelor', 'description': 'Ticagrelor 90mg should be taken as soon as possible. From the 2nd to the 21st day, the patient should receive dual anti - platelet therapy with ticagrelor 90mg twice a day (bid) combined with aspirin 100mg once a day (qd). From the 22nd to the 90th day, the patient should be given ticagrelor 90mg bid for anti - platelet treatment.', 'interventionNames': ['Drug: The ticagrelor']}, {'type': 'OTHER', 'label': 'The Clopidogrel', 'description': 'From the 2nd to the 21st day, the patient should receive dual anti - platelet therapy with clopidogrel 75mg once a day (qd) combined with aspirin 100mg once a day (qd). From the 22nd to the 90th day, the patient should be given clopidogrel 75mg qd for anti - platelet treatment.', 'interventionNames': ['Drug: The Clopidogrel']}], 'interventions': [{'name': 'The ticagrelor', 'type': 'DRUG', 'description': 'Ticagrelor 90mg should be taken as soon as possible. From the 2nd to the 21st day, the patient should receive dual anti - platelet therapy with ticagrelor 90mg twice a day (bid) combined with aspirin 100mg once a day (qd). From the 22nd to the 90th day, the patient should be given ticagrelor 90mg bid for anti - platelet treatment.', 'armGroupLabels': ['The ticagrelor']}, {'name': 'The Clopidogrel', 'type': 'DRUG', 'description': 'From the 2nd to the 21st day, the patient should receive dual anti - platelet therapy with clopidogrel 75mg once a day (qd) combined with aspirin 100mg once a day (qd). From the 22nd to the 90th day, the patient should be given clopidogrel 75mg qd for anti - platelet treatment.', 'armGroupLabels': ['The Clopidogrel']}]}, 'contactsLocationsModule': {'locations': [{'zip': '610072', 'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'contacts': [{'name': 'Jie Yang Deputy Director of the Department of Neurology', 'role': 'CONTACT', 'email': 'yangjie1126@163.com', 'phone': '+86 13678130516'}], 'facility': "Sichuan Provincial People's Hospital", 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}], 'centralContacts': [{'name': 'Jie Yang Deputy Director of the Department of Neurology', 'role': 'CONTACT', 'email': 'yangjie1126@163.com', 'phone': '+8613678130516'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Sichuan Provincial People's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'Fudan University', 'class': 'OTHER'}, {'name': 'Chengdu Medical College', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Deputy Director of the Department of Neurology', 'investigatorFullName': 'Jie Yang', 'investigatorAffiliation': "Sichuan Provincial People's Hospital"}}}}