Antiplatelet Therapy for AIS Patients With Thrombocytopenia

Acute Ischemic Stroke Clinical Trial

— PERSIST  

Official title:

Antiplatelet Therapy for Acute Ischemic Stroke Patients With Thrombocytopenia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06053021
• Other study ID #: PERSIST
• Status: Recruiting
• Phase: N/A
• Start date: September 15, 2023
• Est. completion date: January 1, 2026

Study information

• Verified date: September 2023
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Min Lou, PhD
• Phone: +8613958007213
• Email: loumingxc[@]vip.sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: January 1, 2026
• Est. primary completion date: October 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Ischemic Stroke
• Thrombocytopenia

Intervention

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

Locations

Country	Name	City	State
China	Second Affiliated Hospital, School of Medicine, Zhejiang University	Hangzhou

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	90-day Composite events	Composite events including ischemic stroke, hemorrhagic stroke, myocardial infarction, major extracranial hemorrhage, and vascular death within 90 days after enrollment	90 days
Secondary	90-day ischemic stroke	Ischemic stroke within 90 days after enrollment	90 days
Secondary	90-day hemorrhagic stroke	Hemorrhagic stroke within 90 days after enrollment	90 days
Secondary	90-day myocardial infarction	Myocardial infarction within 90 days after enrollment	90 days
Secondary	90-day major extracranial hemorrhage	Major extracranial hemorrhage within 90 days after enrollment	90 days
Secondary	90-day non-major bleeding	Non-major bleeding within 90 days after enrollment	90 days
Secondary	90-day vascular death	Vascular death within 90 days after enrollment	90 days
Secondary	90-day all-cause death	All-cause death within 90 days after enrollment	90 days
Secondary	Discharge mRS	Modified Rankin scale at discharge	Through hospitalization, an average of 7 days