Acute Coronary Syndrome, Old Myocardial Infarction Clinical Trial
— BRLCEIACS/OMIOfficial title:
Brilinta Tablets 60mg/90mg Clinical Experience Investigation
| Verified date | April 2024 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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
| Status | Active, not recruiting |
| Enrollment | 566 |
| Est. completion date | March 30, 2028 |
| Est. primary completion date | March 30, 2028 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 16 Years to 130 Years |
| Eligibility | Inclusion Criteria: - Patients treated with BRILINTA for ACS or OMI, which is the indication of the drug. Exclusion Criteria: - |
| Country | Name | City | State |
|---|---|---|---|
| Japan | Research Site | Aichi | |
| Japan | Research Site | Aichi | |
| Japan | Research Site | Aichi | |
| Japan | Research Site | Aichi | |
| Japan | Research Site | Akita | |
| Japan | Research Site | Chiba | |
| Japan | Research Site | Chiba | |
| Japan | Research Site | Chiba | |
| Japan | Research Site | Fukuoka | |
| Japan | Research Site | Fukuoka | |
| Japan | Research Site | Fukuoka | |
| Japan | Research Site | Fukuoka | |
| Japan | Research Site | Gifu | |
| Japan | Research Site | Gunma | |
| Japan | Research Site | Gunma | |
| Japan | Research Site | Hokkaido | |
| Japan | Research Site | Hokkaido | |
| Japan | Research Site | Hokkaido | |
| Japan | Research Site | Hokkaido | |
| Japan | Research Site | Hokkaido | |
| Japan | Research Site | Hokkaido | |
| Japan | Research Site | Hyogo | |
| Japan | Research Site | Hyogo | |
| Japan | Research Site | Hyogo | |
| Japan | Research Site | Hyogo | |
| Japan | Research Site | Hyogo | |
| Japan | Research Site | Ibaraki | |
| Japan | Research Site | Ibaraki | |
| Japan | Research Site | Ibaraki | |
| Japan | Research Site | Ibaraki | |
| Japan | Research Site | Kagoshima | |
| Japan | Research Site | Kanagawa | |
| Japan | Research Site | Kanagawa | |
| Japan | Research Site | Kanagawa | |
| Japan | Research Site | Kanagawa | |
| Japan | Research Site | Kochi | |
| Japan | Research Site | Kumamoto | |
| Japan | Research Site | Mie | |
| Japan | Research Site | Mie | |
| Japan | Research Site | Miyagi | |
| Japan | Research Site | Nagano | |
| Japan | Research Site | Nagasaki | |
| Japan | Research Site | Oita | |
| Japan | Research Site | Okayama | |
| Japan | Research Site | Okayama | |
| Japan | Research Site | Okinawa | |
| Japan | Research Site | Okinawa | |
| Japan | Research Site | Okinawa | |
| Japan | Research Site | Osaka | |
| Japan | Research Site | Osaka | |
| Japan | Research Site | Osaka | |
| Japan | Research Site | Osaka | |
| Japan | Research Site | Osaka | |
| Japan | Research Site | Osaka | |
| Japan | Research Site | Osaka | |
| Japan | Research Site | Osaka | |
| Japan | Research Site | Osaka | |
| Japan | Research Site | Osaka | |
| Japan | Research Site | Osaka | |
| Japan | Research Site | Saitama | |
| Japan | Research Site | Saitama | |
| Japan | Research Site | Saitama | |
| Japan | Research Site | Shiga | |
| Japan | Research Site | Shiga | |
| Japan | Research Site | Shiga | |
| Japan | Research Site | Shiga | |
| Japan | Research Site | Shizuoka | |
| Japan | Research Site | Shizuoka | |
| Japan | Research Site | Tochigi | |
| Japan | Research Site | Tokyo | |
| Japan | Research Site | Tokyo | |
| Japan | Research Site | Tokyo | |
| Japan | Research Site | Tokyo | |
| Japan | Research Site | Tokyo | |
| Japan | Research Site | Tokyo | |
| Japan | Research Site | Tokyo | |
| Japan | Research Site | Tokyo | |
| Japan | Research Site | Tokyo | |
| Japan | Research Site | Wakayama | |
| Japan | Research Site | Wakayama | |
| Japan | Research Site | Wakayama | |
| Japan | Research Site | Yamagata | |
| Japan | Research Site | Yamanashi |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
Japan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Adverse event incidence | from baseline to 4 years | ||
| Primary | Incidence of ADRs not expected from "Precautions for Use" of the ticagrelor JPI | from baseline to 4 years | ||
| Primary | Incidence of cardiovascular events | from baseline to 4 years | ||
| Primary | Factors which may affect incidence of bleeding, dyspnoea, bradyarrhythmia, analysed by patient demographic characteristic and by treatment | from baseline to 4 years | ||
| Primary | Factors which may affect incidence of cardiovascular events, analysed by patient demographic characteristic and by treatment | from baseline to 4 years |