NCT06053021

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 11, 2023

Completed
4 days until next milestone

Study Start

First participant enrolled

September 15, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 25, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

October 18, 2023

Status Verified

September 1, 2023

Enrollment Period

2 years

First QC Date

September 11, 2023

Last Update Submit

October 16, 2023

Conditions

Acute Ischemic StrokeThrombocytopenia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • 90-day ischemic stroke

    90 days

  • 90-day hemorrhagic stroke

    90 days

  • 90-day myocardial infarction

    90 days

  • 90-day major extracranial hemorrhage

    90 days

  • 90-day non-major bleeding

    90 days

  • +3 more secondary outcomes

Study Arms (1)

Intervention

EXPERIMENTAL

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

Drug: aspirin, clopidogrel, cilostazol, and dipyridamole

Interventions

aspirin, clopidogrel, cilostazol, and dipyridamoleDRUG

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

Also known as: Antiplatelet Agents
Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, China

RECRUITING

MeSH Terms

Conditions

Ischemic StrokeThrombocytopenia

Interventions

AspirinClopidogrelCilostazolDipyridamolePlatelet Aggregation Inhibitors

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBlood Platelet DisordersHematologic DiseasesHemic and Lymphatic DiseasesCytopenia

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsTiclopidineThienopyridinesThiophenesSulfur CompoundsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingTetrazolesAzolesQuinolinesPyrimidinesHematologic AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and Uses

Central Study Contacts

Min Lou, PhD

CONTACT

+8613958007213loumingxc@vip.sina.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2023

First Posted

September 25, 2023

Study Start

September 15, 2023

Primary Completion

October 1, 2025

Study Completion

January 1, 2026

Last Updated

October 18, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)