Brilinta Clinical Experience Investigation (BRLCEIACS/OMI)

March 1, 2024 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

Active, not recruiting

Study Type

Observational

Enrollment (Actual)

566

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 Locations

      • Aichi, Japan, 454-0933
        • Research Site
      • Aichi, Japan, 460-0001
        • Research Site
      • Aichi, Japan, 470-1101
        • Research Site
      • Aichi, Japan, 491-0036
        • Research Site
      • Akita, Japan, 015-0834
        • Research Site
      • Chiba, Japan, 260-0042
        • Research Site
      • Chiba, Japan, 260-0852
        • Research Site
      • Chiba, Japan, 272-0824
        • Research Site
      • Chiba, Japan, 276-0046
        • Research Site
      • Fukuoka, Japan, 811-3113
        • Research Site
      • Fukuoka, Japan, 814-0005
        • Research Site
      • Fukuoka, Japan, 815-0032
        • Research Site
      • Fukuoka, Japan, 830-0033
        • Research Site
      • Fukuoka, Japan, 830-0047
        • Research Site
      • Gifu, Japan, 500-8226
        • 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, 060-0814
        • Research Site
      • Hokkaido, Japan, 061-1373
        • Research Site
      • Hokkaido, Japan, 063-0005
        • Research Site
      • Hokkaido, Japan, 065-0027
        • 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, 665-0873
        • Research Site
      • Hyogo, Japan, 675-1327
        • Research Site
      • Ibaraki, Japan, 300-0062
        • Research Site
      • Ibaraki, Japan, 300-0332
        • Research Site
      • Ibaraki, Japan, 300-0812
        • Research Site
      • Ibaraki, Japan, 300-2622
        • Research Site
      • Ibaraki, Japan, 311-4145
        • Research Site
      • Kagoshima, Japan, 892-0822
        • Research Site
      • Kanagawa, Japan, 222-0036
        • 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
        • Research Site
      • Mie, Japan, 516-0008
        • Research Site
      • Mie, Japan, 518-0842
        • Research Site
      • Miyagi, Japan, 980-0873
        • Research Site
      • Nagano, Japan, 380-0928
        • 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, 530-0012
        • 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, 596-0822
        • 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, 523-0082
        • Research Site
      • Shiga, Japan, 525-0014
        • Research Site
      • Shiga, Japan, 526-0043
        • Research Site
      • Shizuoka, Japan, 431-3125
        • Research Site
      • Shizuoka, Japan, 434-0031
        • Research Site
      • Tochigi, Japan, 326-0843
        • Research Site
      • Tokyo, Japan, 101-0024
        • Research Site
      • Tokyo, Japan, 104-0044
        • Research Site
      • Tokyo, Japan, 113-0022
        • Research Site
      • Tokyo, Japan, 120-0006
        • Research Site
      • Tokyo, Japan, 141-0001
        • Research Site
      • Tokyo, Japan, 142-0064
        • Research Site
      • Tokyo, Japan, 162-0052
        • Research Site
      • Tokyo, Japan, 173-0015
        • 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

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

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

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)

December 21, 2017

Primary Completion (Estimated)

March 30, 2028

Study Completion (Estimated)

March 30, 2028

Study Registration Dates

First Submitted

June 19, 2017

First Submitted That Met QC Criteria

July 6, 2017

First Posted (Actual)

July 11, 2017

Study Record Updates

Last Update Posted (Estimated)

March 4, 2024

Last Update Submitted That Met QC Criteria

March 1, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

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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