Precise Antiplatelet THerapy Guided by Platelet Aggregation Function in Acute Ischemic STROKE（PATH-STROKE）

Ischemic Stroke Clinical Trial

— PATH-STROKE  

Official title:

Precise Antiplatelet THerapy Guided by Platelet Aggregation Function in Acute Ischemic STROKE

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06269432
• Other study ID #: 2023YFS0042
• Status: Recruiting
• Phase: Phase 4
• Start date: January 1, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: February 2024
• Source: Sichuan Provincial People's Hospital
• Contact: Jie Yang, doctor
• Phone: +86 13678130516
• Email: yangjie1126[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Non cardiogenic cerebral infarction accounts for more than 50% of cerebral infarction, and the key to its onset is an increase in platelet aggregation function. Aspirin is an IA recommended drug for the prevention and treatment of non cardiogenic cerebral infarction. However, after taking aspirin and clopidogrel regularly, more than 30% of stroke patients still experience ischemic events (aspirin resistance, clopidogrel resistance), leading to stroke recurrence. Aspirin is the main antiplatelet drug for the prevention and treatment of non cardiogenic cerebral infarction. Therefore, clinical research on aspirin resistance in the prevention and treatment of non cardiogenic cerebral infarction is of great significance, which can help partially solve the bottleneck of antiplatelet therapy resistance in cerebral infarction. Platelet aggregation function testing can timely detect resistance to antiplatelet therapy, guide drug adjustments, and researchers will compare the experimental group (receiving precise antiplatelet therapy) with the control group (blindly taking aspirin) to see if the experimental group will reduce stroke recurrence or mortality, in order to prevent and treat cerebral infarction with aspirin and clopidogrel resistance and reduce the recurrence rate of cerebral infarction.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Antiplatelet Drug
• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
China	Sichuan Provincial People's Hospital	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Sichuan Provincial People's Hospital

Country where clinical trial is conducted

China, 

References & Publications (11)

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

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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

Outcome

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