Antiplatelet Therapy for AIS Patients With Thrombocytopenia

Not Applicable

Recruiting

• Conditions: Thrombocytopenia; Acute Ischemic Stroke
• Interventions: Drug: aspirin, clopidogrel, cilostazol, and dipyridamole

• Registration Number: NCT06053021
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

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 Timeline

• Status Verified: 2023-09
• Study First Submitted: 2023-09-11
• Study Start: 2023-09-15
• Study First Submitted QC: 2023-09-21
• Study First Posted: 2023-09-25
• Last Update Submitted: 2023-10-16
• Last Update Posted: 2023-10-18
• Primary Completion: 2025-10-01
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

Second Affiliated Hospital, School of Medicine, Zhejiang University; 🇨🇳 Hangzhou, China