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NCT Number: NCT06853535

Precision Antiplatelet Therapy Guided by Platelet Aggregation Function in Patients With Acute Ischemic STROKE

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sichuan Provincial People's Hospital

Chengdu, Sichuan, 610072, China

Location status: Recruiting

Location contact

Jie Yang Deputy Director of the Department of Neurology

CONTACT

[email protected]

+86 13678130516

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years old.
  • 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.
  • 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.)
  • 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.
  • Written informed consent signed by the patient or their legal representative.

Exclusion criteria

  • 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).
  • Minor stroke/TIA induced by angioplasty or vascular surgery.
  • 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.
  • Having definite indications for anticoagulant therapy (suspected cardiogenic embolism, e.g., atrial fibrillation, known artificial heart valve, suspected endocarditis, etc.).
  • 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.
  • Use of antiplatelet agents other than aspirin and clopidogrel (e.g., ticagrelor, prasugrel) within 7 days.
  • 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).
  • 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.
  • Leukopenia (< 2×10⁹/L) or thrombocytopenia (< 100×10⁹/L).
  • Use of heparin or oral anticoagulants within 10 days prior to enrollment.
  • 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).
  • Women of childbearing age with a negative pregnancy test but who refuse to adopt effective contraceptive measures; pregnant or lactating women.
  • Poor compliance, unable to cooperate with the requirements of the study.

Treatment and study plan

The ticagrelor

Drug

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.

The Clopidogrel

Drug

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.

Primary outcomes

  1. Recurrent stroke (including ischemic and hemorrhagic stroke) within 90 days

    Time frame: within 90 days

Secondary outcomes

  1. Recurrent ischemic stroke

    Time frame: On the 7th day, at 30 days, and within 1 year

  2. 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.

  3. 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.

  4. Recurrent stroke

    Time frame: On the 7th day, the 30th day, the 90th day and within one year.

  5. 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

  6. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jie Yang Deputy Director of the Department of Neurology

CONTACT

[email protected]

+8613678130516

Sponsors and collaborators

Lead sponsor

Sichuan Provincial People's Hospital

Other

Collaborators

  • Chengdu Medical College
  • Fudan University

Registry information

Acronym: PATH STROKE C

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 3, 2025
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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