Precision Antiplatelet Therapy Guided by Platelet Aggregation Function in Patients With Acute Ischemic STROKE
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorSichuan Provincial People's Hospital
About this trial
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
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years old.
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.)
Disqualifiers
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.).
Trial design
Design model
Parallel
Treatments tested in this trial
The ticagrelor
DrugTicagrelor 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
DrugFrom 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.
Treatment groups
5,138 Participants
are divided into 2 treatment groupsGroup A: The ticagrelorExperimental treatment 1 intervention
Group B: The ClopidogrelOther 1 intervention
Trial outcomes
Primary outcomes
1
Recurrent stroke (including ischemic and hemorrhagic stroke) within 90 days
Time frame
within 90 daysSecondary outcomes
1
Recurrent ischemic stroke
Time frame
On the 7th day, at 30 days, and within 1 year2
New-onset vascular events
Including cardiovascular and cerebrovascular strokes, myocardial infarctions, and vascular deaths.
Time frame
On the 7th day, at 30 days, at 90 days and within 1 year.3
Modified Rankin Scale (mRS) score
The score range of the scale is from 0 to 6. The higher the score, the worse the outcome.
Time frame
at 30 days, 90 days, and 1 year4
Recurrent stroke
Time frame
On the 7th day, the 30th day, the 90th day and within one year.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Sichuan Provincial People's Hospital
Lead sponsor
Fudan University
Collaborator
Chengdu Medical College
Collaborator
Source ClinicalTrials.gov