Clinical trial NCT06853535: Precision Antiplatelet Therapy Guided by Platelet Aggregation Function in Patients with Acute Ischemic STROKE
Official title: Precision Antiplatelet Therapy Guided by Platelet Aggregation Function in Patients with Acute Ischemic STROKE
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Acute Ischemic Stroke
Clopidogrel Resistance
Lead sponsor: Sichuan Provincial People's Hospital
Sponsor class: OTHER
Collaborators: name: Fudan University
name: Chengdu Medical College
First posted: 2025-03-03
Enrollment: 5138
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 1.Aged between 18 and 80 years old; 2.Diagnosed with non-cardiogenic ischemic stroke or TIA according to WHO criteria, confirmed by cranial CT or MRI to exclude hemorrhagic stroke.; 3.This stroke onset is ≤ 48 hours; (The duration of onset is defined as the time from the last time the patient was seen normal to the time of taking 300 mg of clopidogrel and 100 - 300 mg of aspirin in combination) 4.The NIHSS score is ≤ 5 points before randomization, or for TIA patients, the ABCD2 score is ≥ 4 points; 5.Within 48 hours after the patient's onset, 5 - 20 hours after receiving anti - platelet therapy with a combination of 300 mg of clopidogrel and 100 - 300 mg of aspirin, the measured MARADP is ≥ 35%; 6.The patient or their family member signs a written informed consent form.

Exclusion Criteria:

* 1.Imaging examination indicates hemorrhagic stroke or hemorrhagic transformation.

  2.There is a history of diseases such as atrial fibrillation, left ventricular thrombosis, cardiomyopathy or valvular disease.

  3.There are the following congenital heart diseases: patent foramen ovale, ventricular septal defect, atrial septal defect and tetralogy of Fallot.

  4.Other P2Y12 receptor inhibitors (e.g., ticagrelor, prasugrel) except clopidogrel have been taken within 7 days.

  5.There is a history of gastrointestinal bleeding, intracranial bleeding, recent massive bleeding or blood transfusion (excluding a small amount of hemoptysis and a small amount of abnormal vaginal bleeding), as well as a history of other hemorrhagic diseases caused by abnormal blood coagulation function (such as purpura, etc.).

  6.There are contraindications or intolerance to anti - platelet drugs. 7.Patients with severe cardiac, pulmonary, hepatic and renal insufficiency, and those with serious comorbidities (e.g., cancer, chronic obstructive pulmonary disease, severe dementia, severe heart failure).

  8.Those with poor compliance who cannot cooperate to meet the requirements of the study.

Primary outcomes:
measure: Recurrent stroke (including ischemic and hemorrhagic stroke) within 90 days
timeFrame: within 90 days
Secondary outcomes:
measure: Recurrent ischemic stroke
timeFrame: On the 7th day, at 30 days, and within 1 year
measure: New-onset vascular events
timeFrame: On the 7th day, at 30 days, at 90 days and within 1 year.
measure: Modified Rankin Scale (mRS) score
timeFrame: at 30 days, 90 days, and 1 year
measure: Recurrent stroke
timeFrame: On the 7th day, the 30th day, the 90th day and within one year.
measure: Worsening of nerve damage (an increase in the NIHSS score by ≥ 4 points compared to the baseline)
timeFrame: At the 24th hour and on the 7th day
measure: Quality of life at day 90 [assessed by the EuroQol - 5 dimension (EQ - 5D) questionnaire]
timeFrame: at 90 days
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Sichuan Provincial People's Hospital
state: Sichuan
Study officials:
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