Brilinta Clinical Experience Investigation (BRLCEIACS/OMI)

July 11, 2025 updated by: AstraZeneca

Brilinta Tablets 60mg/90mg Clinical Experience Investigation

To confirm the following safety topics in patients to be treated with BRILINTA tablets 60 mg or 90 mg (hereinafter referred to as "BRILINTA") in clinical practice in the post-marketing phase.

  1. Profile and incidence of ADRs The CEI will be conducted to collect data of the events, especially focusing on bleeding, dyspnoea and bradyarrhythmia so as to investigate onset, outcome, treatment for the event, and risk factors for these events, etc.
  2. Profile and incidence of ADRs not expected from "Precautions for Use" of the ticagrelor JPI
  3. Efficacy: Profile and incidence of cardiovascular events (cardiovascular death, non-fatal myocardial infarction and non-fatal ischemic stroke)
  4. Factors which may affect safety or efficacy of ticagrelor

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
663

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Japan
      • Aichi, Japan, 454-0933
        • Research Site
      • Aichi, Japan, 460-0001
        • Research Site
      • Aichi, Japan, 491-0036
        • Research Site
      • Akita, Japan, 015-0834
        • Research Site
      • Chiba, Japan, 260-0852
        • Research Site
      • Chiba, Japan, 272-0824
        • Research Site
      • Fukuoka, Japan, 811-3113
        • Research Site
      • Fukuoka, Japan, 815-0032
        • Research Site
      • Fukuoka, Japan, 830-0033
        • Research Site
      • Fukuoka, Japan, 830-0047
        • Research Site
      • Gunma, Japan, 371-0811
        • Research Site
      • Gunma, Japan, 371-0821
        • Research Site
      • Hokkaido, Japan, 004-0052
        • Research Site
      • Hokkaido, Japan, 006-0811
        • Research Site
      • Hokkaido, Japan, 061-1373
        • Research Site
      • Hokkaido, Japan, 063-0005
        • Research Site
      • Hokkaido, Japan, 078-8211
        • Research Site
      • Hokkaido, Japan, 093-0076
        • Research Site
      • Hyogo, Japan
        • Research Site
      • Hyogo, Japan, 650-0047
        • Research Site
      • Hyogo, Japan, 651-0053
        • Research Site
      • Hyogo, Japan, 651-1145
        • Research Site
      • Hyogo, Japan, 675-1327
        • Research Site
      • Ibaraki, Japan, 300-0332
        • Research Site
      • Ibaraki, Japan, 300-0812
        • Research Site
      • Ibaraki, Japan, 300-2622
        • Research Site
      • Kagoshima, Japan, 892-0822
        • Research Site
      • Kanagawa, Japan, 238-0011
        • Research Site
      • Kanagawa, Japan, 242-0006
        • Research Site
      • Kanagawa, Japan, 250-0055
        • Research Site
      • Kanagawa, Japan, 259-1143
        • Research Site
      • Kochi, Japan
        • Research Site
      • Kumamoto, Japan, 861-4101
        • Research Site
      • Mie, Japan, 516-0008
        • Research Site
      • Mie, Japan, 518-0842
        • Research Site
      • Miyagi, Japan, 980-0873
        • Research Site
      • Nagasaki, Japan
        • Research Site
      • Oita, Japan, 879-7761
        • Research Site
      • Okayama, Japan, 701-1154
        • Research Site
      • Okayama, Japan, 710-0052
        • Research Site
      • Okinawa, Japan, 900-0005
        • Research Site
      • Okinawa, Japan, 901-2131
        • Research Site
      • Okinawa, Japan, 901-2132
        • Research Site
      • Osaka, Japan
        • Research Site
      • Osaka, Japan, 530-0025
        • Research Site
      • Osaka, Japan, 532-0003
        • Research Site
      • Osaka, Japan, 558-0056
        • Research Site
      • Osaka, Japan, 567-0035
        • Research Site
      • Osaka, Japan, 569-0801
        • Research Site
      • Osaka, Japan, 583-0872
        • Research Site
      • Osaka, Japan, 590-0822
        • Research Site
      • Osaka, Japan, 599-8247
        • Research Site
      • Saitama, Japan, 340-0043
        • Research Site
      • Saitama, Japan, 343-0845
        • Research Site
      • Saitama, Japan, 350-1241
        • Research Site
      • Shiga, Japan, 522-0057
        • Research Site
      • Shiga, Japan, 525-0014
        • Research Site
      • Shizuoka, Japan, 434-0031
        • Research Site
      • Tochigi, Japan, 326-0843
        • Research Site
      • Tochigi, Japan, 321-2523
        • Research Site
      • Tokyo, Japan, 104-0044
        • Research Site
      • Tokyo, Japan, 141-0001
        • Research Site
      • Tokyo, Japan, 142-0064
        • Research Site
      • Tokyo, Japan, 162-0052
        • Research Site
      • Tokyo, Japan, 183-0042
        • Research Site
      • Tokyo, Japan, 206-0025
        • Research Site
      • Wakayama, Japan, 640-8269
        • Research Site
      • Wakayama, Japan, 641-0012
        • Research Site
      • Wakayama, Japan, 646-0015
        • Research Site
      • Yamagata, Japan, 992-0601
        • Research Site
      • Yamanashi, Japan, 400-0027
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years to 130 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients treated with BRILINTA for ACS or OMI, which is the indication of the drug.

Description

Inclusion Criteria:

  • Patients treated with BRILINTA for ACS or OMI, which is the indication of the drug.

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Adverse event incidence
Time Frame: from baseline to 4 years
from baseline to 4 years
Incidence of ADRs not expected from "Precautions for Use" of the ticagrelor JPI
Time Frame: from baseline to 4 years
from baseline to 4 years
Incidence of cardiovascular events
Time Frame: from baseline to 4 years
from baseline to 4 years
Factors which may affect incidence of bleeding, dyspnoea, bradyarrhythmia, analysed by patient demographic characteristic and by treatment
Time Frame: from baseline to 4 years
from baseline to 4 years
Factors which may affect incidence of cardiovascular events, analysed by patient demographic characteristic and by treatment
Time Frame: from baseline to 4 years
from baseline to 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 21, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 19, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 6, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 11, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 16, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 11, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D5133N00007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.

All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

IPD Sharing Time Frame

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing Access Criteria

When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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