PERSIST: Antiplatelet Therapy for AIS Patients With Thrombocytopenia

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06053021

Collaborator

(none)

1,200

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The goal of this clinical trial is to test the safety and effectiveness of antiplatelet therapy in acute ischemic stroke (AIS) patients with thrombocytopenia. Participants will be prescribed antiplatelet agents and followed up for 3 months.

Condition or Disease	Intervention/Treatment	Phase
Acute Ischemic Stroke Thrombocytopenia	Drug: aspirin, clopidogrel, cilostazol, and dipyridamole	N/A

Detailed Description

Antiplatelet therapy is widely used in non-cardiogenic AIS patients for secondary prevention. However, it may also increase the risk of bleeding complications, especially in patients with thrombocytopenia. The goal of this clinical trial is to test the safety and effectiveness of antiplatelet therapy in acute ischemic stroke (AIS) patients with thrombocytopenia. Participants will be prescribed antiplatelet agents and followed up for 3 months.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1200 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Antiplatelet Therapy for Acute Ischemic Stroke Patients With Thrombocytopenia

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Oct 1, 2025

Anticipated Study Completion Date :

Jan 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Participants will be prescribed antiplatelet agents including aspirin, clopidogrel, cilostazol, and dipyridamole.	Drug: aspirin, clopidogrel, cilostazol, and dipyridamole Participants will be prescribed antiplatelet agents including aspirin, clopidogrel, cilostazol, and dipyridamole. Other Names: Antiplatelet Agents

Arm

Intervention/Treatment

Experimental: Intervention

Participants will be prescribed antiplatelet agents including aspirin, clopidogrel, cilostazol, and dipyridamole.

Drug: aspirin, clopidogrel, cilostazol, and dipyridamole

Participants will be prescribed antiplatelet agents including aspirin, clopidogrel, cilostazol, and dipyridamole.

Other Names:

Antiplatelet Agents

Outcome Measures

Primary Outcome Measures

90-day Composite events [90 days]
Composite events including ischemic stroke, hemorrhagic stroke, myocardial infarction, major extracranial hemorrhage, and vascular death within 90 days after enrollment

Secondary Outcome Measures

90-day ischemic stroke [90 days]
Ischemic stroke within 90 days after enrollment
90-day hemorrhagic stroke [90 days]
Hemorrhagic stroke within 90 days after enrollment
90-day myocardial infarction [90 days]
Myocardial infarction within 90 days after enrollment
90-day major extracranial hemorrhage [90 days]
Major extracranial hemorrhage within 90 days after enrollment
90-day non-major bleeding [90 days]
Non-major bleeding within 90 days after enrollment
90-day vascular death [90 days]
Vascular death within 90 days after enrollment
90-day all-cause death [90 days]
All-cause death within 90 days after enrollment
Discharge mRS [Through hospitalization, an average of 7 days]
Modified Rankin scale at discharge

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age > 18 years old
Acute ischemic stroke or transient ischemic attack with onset < 7 days
The last blood routine test before enrollment indicates platelet count < 100 x 10^{9
and > 30 x 10}9

Exclusion Criteria:

Chronic renal dysfunction (GFR < 30ml/min) or severe hepatic injury
Indications for anticoagulation therapy, e.g. atrial fibrillation
Myocardial infarction within 6 months before enrollment or received percutaneous coronary intervention in the past
Have or plan to receive CEA or CAS in the following 3 months
Life expectancy less than 1 year
Plan to receive invasive surgery in the following 3 months and have high risk of uncontrollable bleeding
Pregnant or lactating women
Individuals identified by researchers as unsuitable for participation in the study due to other reasons.