Acute Ischemic Stroke
Conditions
Interventions
Experimental group:Ticagrelor 90mg should be taken as soon as possible. From the 1st to the 21st day, the patient should receive dual anti - platelet therapy with ticagrelor 90mg twice a day (bid) com
Control Group: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
Sponsors
Sichuan Academy of Medical Sciences / Sichuan Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
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 = 4. 3.Time from symptom onset = 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
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 ? or ?); • 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 (< 2×10^9/L) or thrombocytopenia (< 100×10^9/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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recurrent stroke (including ischemic and hemorrhagic stroke) within 90 days; | — |
Secondary
| Measure | Time frame |
|---|---|
| Recurrent ischemic stroke occurring at Day 7 or hospital discharge, Day 30, and 1 year;New-onset vascular events occurring at Day 7 or hospital discharge, Day 30, Day 90, and 1 year, including cardiocerebral stroke, myocardial infarction, and vascular death;Modified Rankin Scale (mRS) scores at Day 30, Day 90, and 1 year;Recurrent stroke occurring at Day 7 or hospital discharge, Day 30, Day 90, and 1 year;Worsening of neurological impairment (an increase of = 4 points in the NIHSS score compared with baseline) at 24 hours, Day 7 or hospital discharge;Quality of life at Day 90, assessed by the EuroQol-5 Dimension (EQ-5D) questionnaire; | — |
Countries
China
Contacts
Public ContactYang Jie
Sichuan Academy of Medical Sciences / Sichuan Provincial People's Hospital
Outcome results
None listed