NCT05716646

Brief Summary

This is a forward-looking, open, one-arm, and real clinical trial world. The researchers plan to recruit at least 50 qualified patients. The main purpose of this study is to establish a population pharmacokinetic model of ticagrelor , explore the correlation between its blood concentration and the events of ischemia and the adverse effects of hemorrhage, and evaluate the effectiveness and safety of ticagrelor in the treatment of ischemic cerebrovascular disease.

Trial Health

65
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Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
31mo left

Started Apr 2023

Longer than P75 for all trials

Status
not yet recruiting

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

Study Progress55%
Apr 2023Dec 2028

First Submitted

Initial submission to the registry

January 29, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 8, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

February 8, 2023

Status Verified

January 1, 2023

Enrollment Period

5.7 years

First QC Date

January 29, 2023

Last Update Submit

January 29, 2023

Conditions

Cerebral InfarctionStrokeNervous System DiseasesIschemic Cerebrovascular Disease

Keywords

Vascular DiseasesTicagrelor

Outcome Measures

Primary Outcomes (1)

  • Correlation between blood drug concentration and adverse events

    Try to find the relationship between pharmacokinetic parameters and adverse events

    6 months

Secondary Outcomes (3)

  • The incidence of adverse events caused by treatment

    6 months

  • NIHSS

    6 months

  • mRS

    6 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with ischemic cerebrovascular disease must sign written informed consent before collecting blood samples

You may qualify if:

  • Female or male aged ≥ 18 years.
  • Clinically diagnosed as ischemic cerebrovascular disease.
  • Take ticagelor for antiplatelet therapy.
  • Provision of informed consent.

You may not qualify if:

  • Head CT or MRI suggests the presence of intracranial hemorrhagic disease.
  • People with tumors and other serious systemic diseases.
  • Allergy to ticagelor.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

Detect the drug concentration in the patient's blood

MeSH Terms

Conditions

Cerebral InfarctionStrokeNervous System DiseasesVascular Diseases

Condition Hierarchy (Ancestors)

Brain InfarctionBrain IschemiaCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesCardiovascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Huang Xin

    Qianfoshan Hospital

    STUDY DIRECTOR

Central Study Contacts

Huang Xin

CONTACT

1379112071113791120711@126.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief pharmacist

Study Record Dates

First Submitted

January 29, 2023

First Posted

February 8, 2023

Study Start

April 1, 2023

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

February 8, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will share
Shared Documents
ICF