Precision Antiplatelet Therapy Guided by Platelet Aggregation Function in Patients With Acute Ischemic STROKE
NCT ID: NCT06853535
Last Updated: 2026-01-21
Study Results
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Basic Information
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RECRUITING
PHASE3
5138 participants
INTERVENTIONAL
2025-05-23
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Fudan University
OTHER
Chengdu Medical College
OTHER
Sichuan Provincial People's Hospital
OTHER
Responsible Party
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Jie Yang
Deputy Director of the Department of Neurology
Locations
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Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
Countries
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Central Contacts
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Jie Yang Deputy Director of the Department of Neurology
Role: CONTACT
Facility Contacts
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Jie Yang Deputy Director of the Department of Neurology
Role: primary
References
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Yang Y, Chen W, Pan Y, Yan H, Meng X, Liu L, Wang Y, Wang Y. Ticagrelor Is Superior to Clopidogrel in Inhibiting Platelet Reactivity in Patients With Minor Stroke or TIA. Front Neurol. 2020 Jun 10;11:534. doi: 10.3389/fneur.2020.00534. eCollection 2020.
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Other Identifiers
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IITLX2025007
Identifier Type: -
Identifier Source: org_study_id
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