Brilinta Clinical Experience Investigation

NCT ID: NCT03212287

Last Updated: 2025-07-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

663 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-12-21

Study Completion Date

2024-07-31

Brief Summary

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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

Detailed Description

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Conditions

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Acute Coronary Syndrome, Old Myocardial Infarction

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

\-
Minimum Eligible Age

16 Years

Maximum Eligible Age

130 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research Site

Aichi, , Japan

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Aichi, , Japan

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Aichi, , Japan

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Akita, , Japan

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Chiba, , Japan

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Chiba, , Japan

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Fukuoka, , Japan

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Fukuoka, , Japan

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Fukuoka, , Japan

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Fukuoka, , Japan

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Gunma, , Japan

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Gunma, , Japan

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Hokkaido, , Japan

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Hokkaido, , Japan

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Hokkaido, , Japan

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Hokkaido, , Japan

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Hokkaido, , Japan

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Hokkaido, , Japan

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Hyōgo, , Japan

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Hyōgo, , Japan

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Hyōgo, , Japan

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Hyōgo, , Japan

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Hyōgo, , Japan

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Ibaraki, , Japan

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Ibaraki, , Japan

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Ibaraki, , Japan

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Kagoshima, , Japan

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Kanagawa, , Japan

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Kanagawa, , Japan

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Kanagawa, , Japan

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Kanagawa, , Japan

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Kochi, , Japan

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Kumamoto, , Japan

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Mie, , Japan

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Mie, , Japan

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Miyagi, , Japan

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Nagasaki, , Japan

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Okayama, , Japan

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Okayama, , Japan

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Okinawa, , Japan

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Okinawa, , Japan

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Okinawa, , Japan

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Osaka, , Japan

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Osaka, , Japan

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Osaka, , Japan

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Osaka, , Japan

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Osaka, , Japan

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Osaka, , Japan

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Osaka, , Japan

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Osaka, , Japan

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Osaka, , Japan

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Ōita, , Japan

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Saitama, , Japan

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Saitama, , Japan

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Saitama, , Japan

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Shiga, , Japan

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Shiga, , Japan

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Shizuoka, , Japan

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Tochigi, , Japan

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Tochigi, , Japan

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Tokyo, , Japan

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Tokyo, , Japan

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Tokyo, , Japan

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Tokyo, , Japan

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Tokyo, , Japan

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Tokyo, , Japan

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Wakayama, , Japan

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Wakayama, , Japan

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Wakayama, , Japan

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Yamagata, , Japan

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Yamanashi, , Japan

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Countries

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Japan

Other Identifiers

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D5133N00007

Identifier Type: -

Identifier Source: org_study_id

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