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Antiplatelet Therapy for AIS Patients With Thrombocytopenia (PERSIST)

Primary Purpose

Acute Ischemic Stroke, Thrombocytopenia

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
aspirin, clopidogrel, cilostazol, and dipyridamole
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Ischemic Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Second Affiliated Hospital, School of Medicine, Zhejiang UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

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

Outcomes

Primary Outcome Measures

90-day Composite events
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
Ischemic stroke within 90 days after enrollment
90-day hemorrhagic stroke
Hemorrhagic stroke within 90 days after enrollment
90-day myocardial infarction
Myocardial infarction within 90 days after enrollment
90-day major extracranial hemorrhage
Major extracranial hemorrhage within 90 days after enrollment
90-day non-major bleeding
Non-major bleeding within 90 days after enrollment
90-day vascular death
Vascular death within 90 days after enrollment
90-day all-cause death
All-cause death within 90 days after enrollment
Discharge mRS
Modified Rankin scale at discharge

Full Information

First Posted
September 11, 2023
Last Updated
October 16, 2023
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
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1. Study Identification

Unique Protocol Identification Number
NCT06053021
Brief Title
Antiplatelet Therapy for AIS Patients With Thrombocytopenia
Acronym
PERSIST
Official Title
Antiplatelet Therapy for Acute Ischemic Stroke Patients With Thrombocytopenia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 15, 2023 (Actual)
Primary Completion Date
October 1, 2025 (Anticipated)
Study Completion Date
January 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Ischemic Stroke, Thrombocytopenia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Participants will be prescribed antiplatelet agents including aspirin, clopidogrel, cilostazol, and dipyridamole.
Intervention Type
Drug
Intervention Name(s)
aspirin, clopidogrel, cilostazol, and dipyridamole
Other Intervention Name(s)
Antiplatelet Agents
Intervention Description
Participants will be prescribed antiplatelet agents including aspirin, clopidogrel, cilostazol, and dipyridamole.
Primary Outcome Measure Information:
Title
90-day Composite events
Description
Composite events including ischemic stroke, hemorrhagic stroke, myocardial infarction, major extracranial hemorrhage, and vascular death within 90 days after enrollment
Time Frame
90 days
Secondary Outcome Measure Information:
Title
90-day ischemic stroke
Description
Ischemic stroke within 90 days after enrollment
Time Frame
90 days
Title
90-day hemorrhagic stroke
Description
Hemorrhagic stroke within 90 days after enrollment
Time Frame
90 days
Title
90-day myocardial infarction
Description
Myocardial infarction within 90 days after enrollment
Time Frame
90 days
Title
90-day major extracranial hemorrhage
Description
Major extracranial hemorrhage within 90 days after enrollment
Time Frame
90 days
Title
90-day non-major bleeding
Description
Non-major bleeding within 90 days after enrollment
Time Frame
90 days
Title
90-day vascular death
Description
Vascular death within 90 days after enrollment
Time Frame
90 days
Title
90-day all-cause death
Description
All-cause death within 90 days after enrollment
Time Frame
90 days
Title
Discharge mRS
Description
Modified Rankin scale at discharge
Time Frame
Through hospitalization, an average of 7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Min Lou, PhD
Phone
+8613958007213
Email
loumingxc@vip.sina.com
Facility Information:
Facility Name
Second Affiliated Hospital, School of Medicine, Zhejiang University
City
Hangzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Min Lou, PhD
Phone
8657187784811
Email
loumingxc@vip.sina.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Antiplatelet Therapy for AIS Patients With Thrombocytopenia

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