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Clinical Trials/NCT06053021
NCT06053021
Recruiting
Not Applicable

Antiplatelet Therapy for Acute Ischemic Stroke Patients With Thrombocytopenia

Second Affiliated Hospital, School of Medicine, Zhejiang University1 site in 1 country1,200 target enrollmentSeptember 15, 2023

Overview

Phase
Not Applicable
Intervention
aspirin, clopidogrel, cilostazol, and dipyridamole
Conditions
Acute Ischemic Stroke
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Enrollment
1200
Locations
1
Primary Endpoint
90-day Composite events
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 15, 2023
End Date
January 1, 2026
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Responsible Party
Sponsor

Eligibility Criteria

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.

Arms & Interventions

Intervention

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

Intervention: aspirin, clopidogrel, cilostazol, and dipyridamole

Outcomes

Primary Outcomes

90-day Composite events

Time Frame: 90 days

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

Secondary Outcomes

  • 90-day myocardial infarction(90 days)
  • 90-day non-major bleeding(90 days)
  • 90-day ischemic stroke(90 days)
  • 90-day all-cause death(90 days)
  • 90-day hemorrhagic stroke(90 days)
  • 90-day major extracranial hemorrhage(90 days)
  • 90-day vascular death(90 days)
  • Discharge mRS(Through hospitalization, an average of 7 days)

Study Sites (1)

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