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

Phase 3

Not yet recruiting

• Conditions: Acute Ischemic Stroke; Clopidogrel Resistance
• Interventions: Drug: The ticagrelor; Drug: The Clopidogrel

• Registration Number: NCT06853535
• Lead Sponsor: Sichuan Provincial People's Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-18
• Study First Submitted QC: 2025-02-28
• Last Update Submitted: 2025-02-28
• Study First Posted: 2025-03-03
• Last Update Posted: 2025-03-03
• Study Start: 2025-04-01
• Primary Completion: 2027-06-30
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 5138

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The ticagrelor	The ticagrelor	Ticagrelor 90mg should be taken as soon as possible. From the 2nd to the 21st day, the patient should receive dual anti - platelet therapy with ticagrelor 90mg twice a day (bid) combined with aspirin 100mg once a day (qd). From the 22nd to the 90th day, the patient should be given ticagrelor 90mg bid for anti - platelet treatment.
The Clopidogrel	The Clopidogrel	From the 2nd 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 Outcome Measures

Name	Time	Method
Recurrent stroke (including ischemic and hemorrhagic stroke) within 90 days	within 90 days

Secondary Outcome Measures

Name	Time	Method
Recurrent ischemic stroke	On the 7th day, at 30 days, and within 1 year
New-onset vascular events	On the 7th day, at 30 days, at 90 days and within 1 year.	Including cardiovascular and cerebrovascular strokes, myocardial infarctions, and vascular deaths.
Modified Rankin Scale (mRS) score	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.
Recurrent stroke	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)	At the 24th hour and on the 7th day
Quality of life at day 90 [assessed by the EuroQol - 5 dimension (EQ - 5D) questionnaire]	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.

Trial Locations

Locations (1)

Sichuan Provincial People's Hospital; 🇨🇳 Chengdu, Sichuan, China