- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03212287
Brilinta Clinical Experience Investigation (BRLCEIACS/OMI)
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
Study Overview
Status
Study Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: AstraZeneca Clinical Study Information Center
- Phone Number: 1-877-240-9479
- Email: information.center@astrazeneca.com
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
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients treated with BRILINTA for ACS or OMI, which is the indication of the drug.
Exclusion Criteria:
-
Study Plan
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
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- D5133N00007
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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
IPD Sharing Access Criteria
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
Clinical Trials on Acute Coronary Syndrome, Old Myocardial Infarction
-
Stony Brook UniversityHennepin County Medical Center, MinneapolisUnknownAcute Coronary Syndrome | STEMI | NSTEMI - Non-ST Segment Elevation MI | Non ST Segment Elevation Myocardial Infarction | Non-ST Elevation Myocardial Infarction | STEMI - ST Elevation Myocardial Infarction | Acute Coronary Artery Thrombosis (Diagnosis) | Non ST Segment Elevation Acute Coronary Syndrome and other conditionsUnited States
-
OrbusNeichGenaeCompletedCoronary Artery Disease | Atherosclerosis | Acute Coronary Syndrome (ACS) | Myocardial Infarction (MI)United Kingdom, Netherlands, Finland, Belgium, Switzerland
-
University of AarhusRegion MidtJylland DenmarkCompletedMyocardial Ischemia | Acute Coronary Syndrome | Acute Myocardial Infarction: Rehabilitation PhaseDenmark
-
Sheba Medical CenterCompletedNon ST Elevation Myocardial Infarction | Acute Coronary SyndromesIsrael
-
Fundación EPICRecruitingCoronary Artery Disease | Acute Coronary Syndrome | Percutaneous Coronary Intervention | Acute Myocardial InfarctionSpain
-
University of ZurichNovartis; Swiss National Science FoundationCompletedAcute Coronary SyndromesSwitzerland, Germany
-
Angel Medical SystemsSymbios ClinicalCompletedAcute Coronary Syndrome | Coronary Occlusion | Acute Myocardial Infarction (AMI)United States
-
Xiangya Hospital of Central South UniversityNot yet recruitingStable Ischemic Heart Disease; Acute Coronary Syndrome; Myocardial Infarction; Myocardial Ischemia
-
Assiut UniversityCompletedNSTEMI - Non-ST Segment Elevation MI | ACS - Acute Coronary Syndrome | Multi Vessel Coronary Artery Disease | STEMI - ST Elevation Myocardial InfarctionEgypt
-
Collegium Medicum w BydgoszczyRecruitingST Elevation Myocardial Infarction | Non ST Segment Elevation Acute Coronary SyndromePoland