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

NCT06269432 | Recruiting Phase 4

• 1 other identifier: 2023YFS0042
• Study Type: interventional
• Target: 1,020
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.Main objective: To explore the efficacy of precise antiplatelet therapy guided by platelet aggregation function in reducing the incidence of 30 day platelet hyperresponsiveness in patients with non-cardiogenic ischemic stroke.
2. 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.

Conditions

Ischemic Stroke; Antiplatelet Drug

Outcome Measures

Primary Outcomes (1)

• The incidence of HOPR at 30 ± 5 days post-enrollment.

  The incidence of HOPR at 30 ± 5days post-enrollment.

  1-month

Secondary Outcomes (1)

• The occurrence of major ischemic events and major bleeding events.

  3-month

Study Arms (2)

Precision Antiplatelet Therapy Trial Group

EXPERIMENTAL

Platelet function testing guides antiplatelet drug selection

Drug: Precision Antiplatelet Therapy Trial Group

Traditional Antiplatelet Therapy Control Group

ACTIVE COMPARATOR

Aspirin 100mg orally once a day

Drug: Traditional Antiplatelet Therapy Control Group

Interventions

Precision Antiplatelet Therapy Trial Group DRUG

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.

Precision Antiplatelet Therapy Trial Group

Traditional Antiplatelet Therapy Control Group DRUG

No adjustment of antiplatelet medication is required, and routine treatment with aspirin 100mg qd is given for 12 months.

Traditional Antiplatelet Therapy Control Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged from 18 to 80 years;
• Diagnosed with non-cardiogenic ischemic stroke according to WHO criteria, confirmed by cranial CT or MRI to exclude hemorrhagic stroke.;
• First stroke onset ≥ 1 month and ≤ 3 months;
• mRS Score \<=2 points;
• Undergoing antiplatelet therapy with 100mg aspirin daily for at least 8 days;
• Informed consent signed by the patient or their family member.

You may not qualify if:

• History of recurrent stroke.
• History of gastrointestinal bleeding, intracranial hemorrhage, or other bleeding disorders.
• Contraindications or intolerance to antiplatelet therapy medications.
• Severe cardiac, pulmonary, hepatic, or renal insufficiency, or presence of severe comorbid conditions (e.g., end-stage malignant tumors, severe single/multiple organ failure).
• Poor compliance, inability to cooperate with study requirements.

Sponsors & Collaborators

• Sichuan Provincial People's Hospital: lead

Study Sites (1)

Sichuan Provincial People's Hospital

Chengdu, Sichuan, 610072, China

RECRUITING

Related Publications (11)

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  PMID: 28052979 BACKGROUND

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  PMID: 27733282 BACKGROUND

• 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: 22052510 BACKGROUND

• 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: 26149036 BACKGROUND

• 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: 28230176 BACKGROUND

• 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: 28228483 BACKGROUND

• 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: 33865495 BACKGROUND

• 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: 31603191 BACKGROUND

• 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: 27581531 BACKGROUND

• 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: 25678901 BACKGROUND

• 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.

  PMID: 29290946 BACKGROUND

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Jie Yang, doctor

  Sichuan Provincial People's Hospital

  STUDY CHAIR

• YaPeng Lin

  First Affiliated Hospital of Chengdu Medical College

  STUDY CHAIR

Central Study Contacts

Jie Yang, doctor

CONTACT

+86 13678130516; yangjie1126@163.com

YaPeng Lin, doctor

CONTACT

+86 13540389801; linyapengsjnk@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director of the Institute of Neurology

Study Record Dates

• First Submitted: January 29, 2024
• First Posted: February 21, 2024
• Study Start: January 1, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)