Acute Coronary Syndrome, Old Myocardial InfarctionBRLCEIACS/OMINCT03212287
Brilinta Clinical Experience Investigation
An observational study of Acute Coronary Syndrome, Old Myocardial Infarction, run by AstraZeneca at 71 sites in Japan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 16 to 130 years
- Conditions the study is for
- Acute Coronary Syndrome, Old Myocardial Infarction
- How many people
- 663 participants
- Where
- 71 sitesJapan
- Study dates
- 21 Dec 2017to 31 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 16 to 130 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients treated with BRILINTA for ACS or OMI, which is the indication of the drug.
Who may be able to join
- Patients treated with BRILINTA for ACS or OMI, which is the indication of the drug.
Who cannot join
- -
Trial locations and contacts
71 sites in 1 country.
71 sites in 1 country
Japan71 sites
Research Site
Aichi, 454-0933
Research Site
Aichi, 460-0001
Research Site
Aichi, 491-0036
Research Site
Akita, 015-0834
Research Site
Chiba, 260-0852
Research Site
Chiba, 272-0824
Research Site
Fukuoka, 811-3113
Research Site
Fukuoka, 815-0032
Research Site
Fukuoka, 830-0033
Research Site
Fukuoka, 830-0047
Research Site
Gunma, 371-0811
Research Site
Gunma, 371-0821
Research Site
Hokkaido, 004-0052
Research Site
Hokkaido, 006-0811
Research Site
Hokkaido, 061-1373
Research Site
Hokkaido, 063-0005
Research Site
Hokkaido, 078-8211
Research Site
Hokkaido, 093-0076
Research Site
Hyōgo, 650-0047
Research Site
Hyōgo, 651-0053
Research Site
Hyōgo, 651-1145
Research Site
Hyōgo, 675-1327
Research Site
Hyōgo
Research Site
Ibaraki, 300-0332
Research Site
Ibaraki, 300-0812
Research Site
Ibaraki, 300-2622
Research Site
Kagoshima, 892-0822
Research Site
Kanagawa, 238-0011
Research Site
Kanagawa, 242-0006
Research Site
Kanagawa, 250-0055
Research Site
Kanagawa, 259-1143
Research Site
Kochi
Research Site
Kumamoto, 861-4101
Research Site
Mie, 516-0008
Research Site
Mie, 518-0842
Research Site
Miyagi, 980-0873
Research Site
Nagasaki
Research Site
Ōita, 879-7761
Research Site
Okayama, 701-1154
Research Site
Okayama, 710-0052
Research Site
Okinawa, 900-0005
Research Site
Okinawa, 901-2131
Research Site
Okinawa, 901-2132
Research Site
Osaka, 530-0025
Research Site
Osaka, 532-0003
Research Site
Osaka, 558-0056
Research Site
Osaka, 567-0035
Research Site
Osaka, 569-0801
Research Site
Osaka, 583-0872
Research Site
Osaka, 590-0822
Research Site
Osaka, 599-8247
Research Site
Osaka
Research Site
Saitama, 340-0043
Research Site
Saitama, 343-0845
Research Site
Saitama, 350-1241
Research Site
Shiga, 522-0057
Research Site
Shiga, 525-0014
Research Site
Shizuoka, 434-0031
Research Site
Tochigi, 321-2523
Research Site
Tochigi, 326-0843
Research Site
Tokyo, 104-0044
Research Site
Tokyo, 141-0001
Research Site
Tokyo, 142-0064
Research Site
Tokyo, 162-0052
Research Site
Tokyo, 183-0042
Research Site
Tokyo, 206-0025
Research Site
Wakayama, 640-8269
Research Site
Wakayama, 641-0012
Research Site
Wakayama, 646-0015
Research Site
Yamagata, 992-0601
Research Site
Yamanashi, 400-0027
About this study
Official title: 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.
- 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.
- Profile and incidence of ADRs not expected from "Precautions for Use" of the ticagrelor JPI
- Efficacy: Profile and incidence of cardiovascular events (cardiovascular death, non-fatal myocardial infarction and non-fatal ischemic stroke)
- Factors which may affect safety or efficacy of ticagrelor
- Medical subject headings
- Acute Coronary Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse event incidence
Measured: from baseline to 4 years
Incidence of ADRs not expected from "Precautions for Use" of the ticagrelor JPI
Measured: from baseline to 4 years
Incidence of cardiovascular events
Measured: from baseline to 4 years
Factors which may affect incidence of bleeding, dyspnoea, bradyarrhythmia, analysed by patient demographic characteristic and by treatment
Measured: from baseline to 4 years
Factors which may affect incidence of cardiovascular events, analysed by patient demographic characteristic and by treatment
Measured: from baseline to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study start21 Dec 2017
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary Syndrome, Old Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Case only
- Time perspective
- Prospective
- Enrolment
- 663 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03212287
- Sponsor's protocol ID
- D5133N00007
- Acronym
- BRLCEIACS/OMI
- Status last verified
- Jul 2025
- First submitted
- 19 Jun 2017
- Last updated
- 16 Jul 2025
- Results posted
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brilinta Tablets 60mg/90mg Clinical Experience Investigation
- ClinicalTrials.gov ID
- NCT03212287
- Acronym / sponsor ID
- BRLCEIACS/OMI / D5133N00007
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 663 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 21 Dec 2017 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 11 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
- Profile and incidence of ADRs not expected from "Precautions for Use" of the ticagrelor JPI
- Efficacy: Profile and incidence of cardiovascular events (cardiovascular death, non-fatal myocardial infarction and non-fatal ischemic stroke)
- Factors which may affect safety or efficacy of ticagrelor
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients treated with BRILINTA for ACS or OMI, which is the indication of the drug.
Key inclusion criteria (1 listed)
- Patients treated with BRILINTA for ACS or OMI, which is the indication of the drug.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Adverse event incidence
Time frame: 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
Incidence of cardiovascular events
Time frame: 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
Factors which may affect incidence of cardiovascular events, analysed by patient demographic characteristic and by treatment
Time frame: from baseline to 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
- Redacted CSR SynopsisLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
71 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome, Old Myocardial Infarction, run by AstraZeneca at 71 sites in Japan.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 71 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse event incidence (time frame: from baseline to 4 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jul 2025; AzTrials last refreshed its copy on 30 Oct 2026.