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
Qualifiers
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
Treatments tested in this trial
- The ticagrelor
- The Clopidogrel
Treatment groups
5,138 Participants
are divided into 2 treatment groupsSponsors and collaborators
Sichuan Provincial People's Hospital
Lead sponsor
Fudan University
Collaborator
Chengdu Medical College
Collaborator
Source ClinicalTrials.gov