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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥ 18 years old.

• 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 ≤ 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.)

• MARADP ≥ 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.

• Written informed consent signed by the patient or their legal representative.

Locations
Other Locations
China
Sichuan Provincial People's Hospital
RECRUITING
Chengdu
Contact Information
Primary
Jie Yang Deputy Director of the Department of Neurology
yangjie1126@163.com
+8613678130516
Time Frame
Start Date: 2025-05-23
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 5138
Treatments
Experimental: The ticagrelor
Ticagrelor 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.
Other: The Clopidogrel
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 the 90th day, the patient should be given clopidogrel 75mg qd for anti - platelet treatment.
Related Therapeutic Areas
Sponsors
Leads: Sichuan Provincial People's Hospital
Collaborators: Chengdu Medical College, Fudan University

This content was sourced from clinicaltrials.gov