In the Real World Study, the Efficacy and Adverse Reactions of Ticagrelor on Ischemic Cerebrovascular Disease

NCT ID: NCT05716646

Last Updated: 2023-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-04-30

Study Completion Date

2028-12-31

Brief Summary

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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.

Detailed Description

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Ischemic stroke and transient ischemic attack are the most common types of ischemic cerebrovascular disease. Patients will suffer from physiological function damage, even mental symptoms, social function and other obstacles, seriously affecting the quality of life, and bringing heavy burden to families and society.

Ticagelor is a new P2Y12 receptor antagonist. Compared with clopidogrel, ticagelor has stronger and more lasting platelet inhibition, and can reduce the recurrence of ischemic events in patients with acute coronary syndrome .

Therefore, at least 50 patients with ischemic cerebrovascular disease using ticagelor will be included. Before and after treatment, the laboratory examination data, NIHSS, mRS, combined medication and adverse events, and ischemic events of the patients will be collected. The population pharmacokinetics model of Ticagelor was established to evaluate its effectiveness and safety.

Conditions

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Cerebral Infarction Stroke Nervous System Diseases Ischemic Cerebrovascular Disease

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. Head CT or MRI suggests the presence of intracranial hemorrhagic disease.
2. People with tumors and other serious systemic diseases.
3. Allergy to ticagelor.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Qianfoshan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Xin Huang

Chief pharmacist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Huang Xin

Role: STUDY_DIRECTOR

Qianfoshan Hospital

Central Contacts

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Huang Xin

Role: CONTACT

13791120711

Other Identifiers

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QFS-HX-2022-TGRL-001

Identifier Type: -

Identifier Source: org_study_id

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