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Cerebral InfarctionNCT05716646

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

An observational study of Cerebral Infarction and Stroke, run by Qianfoshan Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
How many people
50 participants
Where
No sites listed yet
Study dates
Apr 2023to Dec 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Huang Xin contact

13791120711

13791120711@126.com

About this study

Official title: Real-world Study on the Efficacy and Safety of Ticagrelor in the Treatment of Ischemic Cerebrovascular Disease

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.

Read the detailed description

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.

Keywords
Vascular Diseases, Ticagrelor
Medical subject headings
Cerebral Infarction, Stroke, Nervous System Diseases, Vascular Diseases

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Correlation between blood drug concentration and adverse events

    Try to find the relationship between pharmacokinetic parameters and adverse events

    Measured: 6 months

Secondary outcomes (3)

  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.

    Measured: 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%

    Measured: 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.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Feb 2023
  2. Study startApr 2023 (estimated)
  3. Primary completionDec 2028 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05716646
Sponsor's protocol ID
QFS-HX-2022-TGRL-001
Status last verified
Jan 2023
First submitted
29 Jan 2023
Last updated
8 Feb 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Cerebral Infarction and Stroke, run by Qianfoshan Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Huang Xin (13791120711, 13791120711@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Correlation between blood drug concentration and adverse events (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05716646.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.

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