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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorQianfoshan Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female or male aged ≥ 18 years.

Clinically diagnosed as ischemic cerebrovascular disease.

Take ticagelor for antiplatelet therapy.

Provision of informed consent.

Disqualifiers

Head CT or MRI suggests the presence of intracranial hemorrhagic disease.

People with tumors and other serious systemic diseases.

Allergy to ticagelor.

Trial population

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

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Correlation between blood drug concentration and adverse events

Try to find the relationship between pharmacokinetic parameters and adverse events

Time frame
6 months

Secondary outcomes

1

The incidence of adverse events caused by treatment

In a clinical trial, the probability of an unexpected and adverse medical event that occurs after a patient or clinical subject receives a trial drug, but it does not necessarily have a causal relationship with the treatment.

Time frame
6 months
2

NIHSS

NIH stroke scale (NIHSS) to assess the degree of neurological deficit in stroke patients. The score ranges from 0 to 42 points, the higher the score, the more severe the nerve damage. Patients with a baseline assessment of\> 16 points are likely to die, while those with a score of \<6 are likely to recover well; for each additional point, the probability of a good prognosis is reduced by 17%

Time frame
6 months
3

mRS

Modified Rankin scale (mRS) is an indicator of the efficacy of functional disability. The score ranges from 0 to 5 points, and the clinical score will be increased to 6 points to indicate death. The higher the score, the more disability the patient is.

Time frame
6 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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