Precise Antiplatelet THerapy Guided by Platelet Aggregation Function in Ischemic STROKE（PATH-STROKE）
NCT ID: NCT06269432
Last Updated: 2025-06-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
1020 participants
INTERVENTIONAL
2023-01-01
2025-12-31
Brief Summary
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2. Secondary objective: To explore the efficacy and safety of antiplatelet therapy in patients with non-cardiogenic ischemic stroke under the guidance of platelet aggregation function.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Precision Antiplatelet Therapy Trial Group
Platelet function testing guides antiplatelet drug selection
Precision Antiplatelet Therapy Trial Group
Use SPCM method to detect platelet aggregation function in patients, adjust antiplatelet drugs based on the test results, and receive precise antiplatelet treatment for 12 months. Non resistant patients with aspirin will continue to receive aspirin 100mg qd; Patients with aspirin resistance were given clopidogrel 75mg qd; Clopidogrel resistant patients were given ticagrelor 90mg bid.
Traditional Antiplatelet Therapy Control Group
Aspirin 100mg orally once a day
Traditional Antiplatelet Therapy Control Group
No adjustment of antiplatelet medication is required, and routine treatment with aspirin 100mg qd is given for 12 months.
Interventions
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Precision Antiplatelet Therapy Trial Group
Use SPCM method to detect platelet aggregation function in patients, adjust antiplatelet drugs based on the test results, and receive precise antiplatelet treatment for 12 months. Non resistant patients with aspirin will continue to receive aspirin 100mg qd; Patients with aspirin resistance were given clopidogrel 75mg qd; Clopidogrel resistant patients were given ticagrelor 90mg bid.
Traditional Antiplatelet Therapy Control Group
No adjustment of antiplatelet medication is required, and routine treatment with aspirin 100mg qd is given for 12 months.
Eligibility Criteria
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Inclusion Criteria
2. Diagnosed with non-cardiogenic ischemic stroke according to WHO criteria, confirmed by cranial CT or MRI to exclude hemorrhagic stroke.;
3. First stroke onset ≥ 1 month and ≤ 3 months;
4. mRS Score \<=2 points;
5. Undergoing antiplatelet therapy with 100mg aspirin daily for at least 8 days;
6. Informed consent signed by the patient or their family member.
Exclusion Criteria
2. History of gastrointestinal bleeding, intracranial hemorrhage, or other bleeding disorders.
3. Contraindications or intolerance to antiplatelet therapy medications.
4. Severe cardiac, pulmonary, hepatic, or renal insufficiency, or presence of severe comorbid conditions (e.g., end-stage malignant tumors, severe single/multiple organ failure).
5. Poor compliance, inability to cooperate with study requirements.
18 Years
80 Years
ALL
No
Sponsors
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Sichuan Provincial People's Hospital
OTHER
Responsible Party
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Jie Yang
Deputy Director of the Institute of Neurology
Principal Investigators
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Jie Yang, doctor
Role: STUDY_CHAIR
Sichuan Provincial People's Hospital
YaPeng Lin
Role: STUDY_CHAIR
First Affiliated Hospital of Chengdu Medical College
Locations
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Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
GBD 2015 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 310 diseases and injuries, 1990-2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet. 2016 Oct 8;388(10053):1545-1602. doi: 10.1016/S0140-6736(16)31678-6.
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.
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.
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.
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.
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.
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.
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.
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.
Yi X, Lin J, Wang C, Huang R, Han Z, Li J. Platelet function-guided modification in antiplatelet therapy after acute ischemic stroke is associated with clinical outcomes in patients with aspirin nonresponse. Oncotarget. 2017 Nov 7;8(63):106258-106269. doi: 10.18632/oncotarget.22293. eCollection 2017 Dec 5.
Other Identifiers
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2023YFS0042
Identifier Type: -
Identifier Source: org_study_id
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