Antiplatelet Therapy for AIS Patients With Thrombocytopenia (PERSIST)

October 16, 2023 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

Antiplatelet Therapy for Acute Ischemic Stroke 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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

1200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Hangzhou, China
        • Recruiting
        • Second Affiliated Hospital, School of Medicine, Zhejiang University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
90 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2023

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

September 11, 2023

First Submitted That Met QC Criteria

September 21, 2023

First Posted (Actual)

September 25, 2023

Study Record Updates

Last Update Posted (Actual)

October 18, 2023

Last Update Submitted That Met QC Criteria

October 16, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PERSIST

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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