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Antiplatelet Therapy for AIS Patients With Thrombocytopenia (PERSIST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06053021
Recruitment Status : Recruiting
First Posted : September 25, 2023
Last Update Posted : October 18, 2023
Sponsor:
Information provided by (Responsible Party):
Second Affiliated Hospital, School of Medicine, Zhejiang University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Acute Ischemic Stroke Thrombocytopenia Drug: aspirin, clopidogrel, cilostazol, and dipyridamole Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Antiplatelet Therapy for Acute Ischemic Stroke Patients With Thrombocytopenia
Actual Study Start Date : September 15, 2023
Estimated Primary Completion Date : October 1, 2025
Estimated Study Completion Date : January 1, 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: Antiplatelet Agents


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 90-day ischemic stroke [ Time Frame: 90 days ]
    Ischemic stroke within 90 days after enrollment

  2. 90-day hemorrhagic stroke [ Time Frame: 90 days ]
    Hemorrhagic stroke within 90 days after enrollment

  3. 90-day myocardial infarction [ Time Frame: 90 days ]
    Myocardial infarction within 90 days after enrollment

  4. 90-day major extracranial hemorrhage [ Time Frame: 90 days ]
    Major extracranial hemorrhage within 90 days after enrollment

  5. 90-day non-major bleeding [ Time Frame: 90 days ]
    Non-major bleeding within 90 days after enrollment

  6. 90-day vascular death [ Time Frame: 90 days ]
    Vascular death within 90 days after enrollment

  7. 90-day all-cause death [ Time Frame: 90 days ]
    All-cause death within 90 days after enrollment

  8. Discharge mRS [ Time Frame: Through hospitalization, an average of 7 days ]
    Modified Rankin scale at discharge


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06053021


Contacts
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Contact: Min Lou, PhD +8613958007213 loumingxc@vip.sina.com

Locations
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China
Second Affiliated Hospital, School of Medicine, Zhejiang University Recruiting
Hangzhou, China
Contact: Min Lou, PhD    8657187784811    loumingxc@vip.sina.com   
Sponsors and Collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University
More Information
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Responsible Party: Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier: NCT06053021    
Other Study ID Numbers: PERSIST
First Posted: September 25, 2023    Key Record Dates
Last Update Posted: October 18, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ischemic Stroke
Thrombocytopenia
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Blood Platelet Disorders
Hematologic Diseases
Cytopenia
Aspirin
Cilostazol
Dipyridamole
 Clopidogrel
Platelet Aggregation Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase Inhibitors
Enzyme Inhibitors