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CompletedNCT06269432PATH-STROKEUpdated Jun 15, 2026

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

A Phase 4 interventional study of Precision Antiplatelet Therapy Trial Group and Traditional Antiplatelet Therapy Control Group in Ischemic Stroke and Antiplatelet Drug, sponsored by Sichuan Provincial People's Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-06-15.

Sponsored by Sichuan Provincial People's Hospital · Phase 4, Interventional, and Prevention

From the registry’s dates

  • Registered 1 year after the study started (first participant enrolled Jan 2023, registered Jan 2024).
Phase
Phase 4
Study type
Interventional
Enrollment
1,224
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

  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. 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.
Read the detailed description

Non cardiac cerebral infarction accounts for more than 50% of cerebral infarction cases, and the key to its onset is increased platelet aggregation function. Aspirin and clopidogrel are Class A recommended drugs for the prevention and treatment of non cardiac cerebral infarction. However, after regular use of aspirin and clopidogrel, more than 30% of stroke patients still experience high on treatment platelet reactivity (HOPR) due to aspirin resistance and clopidogrel resistance, leading to stroke recurrence. Antiplatelet therapy is the cornerstone of the prevention and treatment of non cardiogenic cerebral infarction. Therefore, clinical research on the prevention and treatment of HOPR with antiplatelet therapy for non cardiogenic cerebral infarction is of great significance, which can help partially solve the bottleneck of resistance to antiplatelet therapy in cerebral infarction.Platelet aggregation function testing can timely detect antiplatelet therapy HOPR, guide drug adjustment, and is expected to become a testing standard for the prevention and treatment of antiplatelet therapy resistance.

02

Conditions studied

  • Ischemic Stroke
  • Antiplatelet Drug

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03

In context

Ischemic Stroke

2,593 studies on the registry are indexed under Ischemic Stroke; 930 are open to participants now.

This study's enrollment of 1,224 is above the median of 120 across 1,752 interventional studies indexed under Ischemic Stroke.

Browse Ischemic Stroke studies →

Lead sponsor

Sichuan Provincial People's Hospital is the lead sponsor of 76 studies on the registry; 43 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Aged from 18 to 80 years;
  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

Exclusion Criteria:

  1. History of recurrent stroke.
  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.
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
1,224 participants (actual)

Study arms

  • Experimental
    Precision Antiplatelet Therapy Trial Group

    Platelet function testing guides antiplatelet drug selection

    Drug: Precision Antiplatelet Therapy Trial Group

  • Active comparator
    Traditional Antiplatelet Therapy Control Group

    Aspirin 100mg orally once a day

    Drug: Traditional Antiplatelet Therapy Control Group

Interventions

  • DrugPrecision 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.

  • DrugTraditional Antiplatelet Therapy Control Group

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

06

What researchers measure

Primary outcomes

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

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

    Time frame: 1-month

Secondary outcomes

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

    Including cardiovascular and cerebrovascular death, myocardial infarction, stroke, urgent revascularization, in-stent thrombosis, and bleeding events classified as BARC grade 2 or higher.

    Time frame: 3-month

07

Study locations

1 site
  • Sichuan Provincial People's Hospital
    Chengdu, Sichuan 610072, China
08

References and documents

Publications

  • 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. PubMed 28052979 ↗
  • 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. PubMed 27733282 ↗
  • 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. PubMed 22052510 ↗
  • 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. PubMed 26149036 ↗
  • 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. PubMed 28230176 ↗
  • 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. PubMed 28228483 ↗
  • 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. PubMed 33865495 ↗
  • 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. PubMed 31603191 ↗
  • 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. PubMed 27581531 ↗
  • 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. PubMed 25678901 ↗
  • 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. PubMed 29290946 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06269432
Lead sponsor
Sichuan Provincial People's Hospital
Responsible party
Jie Yang (Deputy Director of the Institute of Neurology, Sichuan Provincial People's Hospital) — Principal investigator
First posted
Feb 21, 2024
Start date
Jan 1, 2023
Primary completion
Sep 30, 2024
Completion
Sep 30, 2025
Last update
Jun 15, 2026

Study contacts

Jie Yang, doctor
study chair · Sichuan Provincial People's Hospital
YaPeng Lin
study chair · First Affiliated Hospital of Chengdu Medical College

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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