Ischemic Stroke Clinical Trial
— PATH-STROKEOfficial title:
Precise Antiplatelet THerapy Guided by Platelet Aggregation Function in Acute Ischemic STROKE
Objectives of Study:To explore the efficacy and safety of antiplatelet therapy in patients with non-cardiogenic cerebral infarction under the guidance of platelet aggregation function.
Status | Recruiting |
Enrollment | 3524 |
Est. completion date | December 31, 2025 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: 1. Aged from 18 to 80 years; 2. Patients with non-cardiogenic cerebral infarction WHO meet the definition of stroke, who have been ruled out hemorrhagic stroke by head CT or MRI examination and identified as ischemic stroke; 3. The onset of first stroke >=1 month; 4. mRS Score <=2 points; 5. Mab platelet therapy with aspirin 100mg qd for >=14 days; 6. Informed consent signed by the patient or legal representative. Exclusion Criteria: 1. History of gastrointestinal bleeding, intracranial bleeding, and other hemorrhagic diseases; 2. Contraindications or intolerances to the use of antiplatelet therapy drugs; 3. Patients with severe heart, lung, liver and renal insufficiency and with serious co-existing diseases (such as tumor, chronic airflow disease, severe dementia, and severe heart failure; 4. Poor compliance, unable to cooperate with the completion of research requirements. |
Country | Name | City | State |
---|---|---|---|
China | Sichuan Provincial People's Hospital | Chengdu | Sichuan |
Lead Sponsor | Collaborator |
---|---|
Sichuan Provincial People's Hospital |
China,
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. — View 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. — View 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. — View 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. — View Citation
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. Erratum In: Lancet. 2017 Jan 7;389(10064):e1. — View 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. — View 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. — View 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. — View Citation
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. — View 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. — View 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. — View Citation
* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 3-month major ischemic events and major bleeding events | Including any of the following: Cardiovascular and cerebrovascular mortality, Incidence of stroke (including ischemic and hemorrhagic), Incidence of myocardial infarction, bleeding events classified by BARC (Bleeding Academic Research Consortium) criteria | 3-month | |
Secondary | disability | mRS(Modified Rankin Scale)>2 | 3-month | |
Secondary | Cardiovascular or cerebrovascular mortality | mortality of Cardiovascular or cerebrovascular disease | 3-month |
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