Precision Antiplatelet Therapy Guided by Platelet Aggregation Function in Patients With Acute Ischemic STROKE (PATH STROKE C)

May 11, 2026 updated by: Jie Yang, Sichuan Provincial People's Hospital
The objective of this clinical trial is to evaluate the efficacy and safety of platelet aggregation function - guided precision anti - platelet therapy in patients with acute cerebral infarction. The main question it aims to answer is: among the cerebral infarction patients with possible clopidogrel resistance detected by platelet aggregation function tests, what is the efficacy and safety of using ticagrelor to replace the clopidogrel treatment regimen.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

5138

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Jie Yang Deputy Director of the Department of Neurology
  • Phone Number: +8613678130516
  • Email: yangjie1126@163.com

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610072
        • Recruiting
        • Sichuan Provincial People's Hospital
        • Contact:
          • Jie Yang Deputy Director of the Department of Neurology
          • Phone Number: +86 13678130516
          • Email: yangjie1126@163.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age ≥ 18 years old.

  2. Patients diagnosed with acute non-disabling ischaemic stroke or transient ischaemic attack (TIA) with moderate to high stroke risk in accordance with the WHO diagnostic criteria, defined as follows:

    • Acute non-disabling ischaemic stroke: NIHSS score ≤ 5 at enrollment;
    • TIA with moderate to high stroke risk: ABCD₂ score ≥ 4.
  3. Time from symptom onset ≤ 48 hours. (Definition of symptom onset time: the interval from the last time the patient was observed in a normal state to the time of co-administration of clopidogrel 300 mg and aspirin 100 mg.)
  4. MARADP ≥ 35% measured at 5-20 hours after the patient received antiplatelet therapy with co-administration of clopidogrel 300 mg and aspirin 100 mg within 48 hours of symptom onset.
  5. Written informed consent signed by the patient or their legal representative.

Exclusion Criteria:

  1. Imaging examinations suggestive of hemorrhagic stroke, hemorrhagic transformation, or other pathological cerebral disorders, such as vascular malformation, tumor, abscess, or other common non-ischemic cerebral diseases (e.g., multiple sclerosis).
  2. Minor stroke/TIA induced by angioplasty or vascular surgery.
  3. Routine electrocardiogram (ECG) suggestive of atrial fibrillation (AF), or physical examination findings of typical AF signs including completely irregular cardiac rhythm, variable intensity of the first heart sound, and pulse deficit.
  4. Having definite indications for anticoagulant therapy (suspected cardiogenic embolism, e.g., atrial fibrillation, known artificial heart valve, suspected endocarditis, etc.).
  5. Patients who have received intravenous thrombolysis, intra-arterial thrombolysis, mechanical thrombectomy, or any revascularization surgery after the current onset, or plan to receive such procedures within 90 days.
  6. Use of antiplatelet agents other than aspirin and clopidogrel (e.g., ticagrelor, prasugrel) within 7 days.
  7. History of gastrointestinal bleeding, intracranial hemorrhage, massive hemorrhage or blood transfusion in the recent period (excluding mild hemoptysis and mild abnormal vaginal bleeding), or history of other hemorrhagic diseases caused by coagulation dysfunction (e.g., purpura).

  8. Having contraindications to or intolerance of clopidogrel, ticagrelor, or aspirin, including:

    • Known history of hypersensitivity;
    • Severe hepatic or renal insufficiency (definition of severe hepatic insufficiency: ALT > 2× upper limit of normal [ULN] or AST > 2× ULN; definition of severe renal insufficiency: creatinine > 1.5× ULN);
    • Severe heart failure (NYHA Class Ⅲ or Ⅳ);
    • Coagulation disorders or history of systemic hemorrhage;
    • History of previous thrombocytopenia or neutropenia;
    • History of previous drug-induced hematological diseases or hepatic dysfunction.
  9. Leukopenia (< 2×10⁹/L) or thrombocytopenia (< 100×10⁹/L).
  10. Use of heparin or oral anticoagulants within 10 days prior to enrollment.
  11. Patients with severe cardiac, pulmonary, hepatic, or renal insufficiency, and those with severe comorbidities (e.g., malignancy, chronic airflow limitation, severe dementia, severe heart failure).
  12. Women of childbearing age with a negative pregnancy test but who refuse to adopt effective contraceptive measures; pregnant or lactating women.
  13. Poor compliance, unable to cooperate with the requirements of the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: The ticagrelor

Ticagrelor 90 mg should be administered as early as possible (within 12-24 hours after the loading dose).

From Day 1 to Day 21 after enrollment: Patients shall receive dual antiplatelet therapy with oral ticagrelor 90 mg bid and aspirin 100 mg qd.

From Day 22 to Day 90 after enrollment: Patients shall receive monotherapy with oral ticagrelor 90 mg bid.
Drug: The ticagrelor

Ticagrelor 90 mg should be administered as early as possible (within 12-24 hours after the loading dose).

From Day 1 to Day 21 after enrollment: Patients shall receive dual antiplatelet therapy with oral ticagrelor 90 mg bid and aspirin 100 mg qd.

From Day 22 to Day 90 after enrollment: Patients shall receive monotherapy with oral ticagrelor 90 mg bid.
Other: The Clopidogrel
From the 1st to the 21st day, the patient should receive dual anti - platelet therapy with clopidogrel 75mg once a day (qd) combined with aspirin 100mg once a day (qd). From the 22nd to the 90th day, the patient should be given clopidogrel 75mg qd for anti - platelet treatment.
Drug: The Clopidogrel
From the 1st to the 21st day, the patient should receive dual anti - platelet therapy with clopidogrel 75mg once a day (qd) combined with aspirin 100mg once a day (qd). From the 22nd to the 90th day, the patient should be given clopidogrel 75mg qd for anti - platelet treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Recurrent stroke (including ischemic and hemorrhagic stroke) within 90 days
Time Frame: within 90 days
within 90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrent ischemic stroke
Time Frame: On the 7th day, at 30 days, and within 1 year
On the 7th day, at 30 days, and within 1 year
New-onset vascular events
Time Frame: On the 7th day, at 30 days, at 90 days and within 1 year.
Including cardiovascular and cerebrovascular strokes, myocardial infarctions, and vascular deaths.
On the 7th day, at 30 days, at 90 days and within 1 year.
Modified Rankin Scale (mRS) score
Time Frame: at 30 days, 90 days, and 1 year
The score range of the scale is from 0 to 6. The higher the score, the worse the outcome.
at 30 days, 90 days, and 1 year
Recurrent stroke
Time Frame: On the 7th day, the 30th day, the 90th day and within one year.
On the 7th day, the 30th day, the 90th day and within one year.
Worsening of nerve damage (an increase in the NIHSS score by ≥ 4 points compared to the baseline)
Time Frame: At the 24th hour and on the 7th day
At the 24th hour and on the 7th day
Quality of life at day 90 [assessed by the EuroQol - 5 dimension (EQ - 5D) questionnaire]
Time Frame: at 90 days
It is usually represented by a value between 0 and 1, where 1 represents perfect health, 0 represents death, and the intermediate values reflect different degrees of health status.
at 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sichuan Provincial People's Hospital

Collaborators

Fudan University
Chengdu Medical College

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 23, 2025

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

February 18, 2025

First Submitted That Met QC Criteria

February 28, 2025

First Posted (Actual)

March 3, 2025

Study Record Updates

Last Update Posted (Actual)

May 12, 2026

Last Update Submitted That Met QC Criteria

May 11, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IITLX2025007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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