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OpenTrials
Completed

NCT Number: NCT03212287

Brilinta 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

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Key information

Conditions

Acute Coronary Syndrome, Old Myocardial Infarction Acute Coronary Syndrome Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

16 year–130 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Aichi, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

-

Treatment and study plan

Primary outcomes

  1. Adverse event incidence

    Time frame: from baseline to 4 years

  2. Incidence of ADRs not expected from "Precautions for Use" of the ticagrelor JPI

    Time frame: from baseline to 4 years

  3. Incidence of cardiovascular events

    Time frame: from baseline to 4 years

  4. Factors which may affect incidence of bleeding, dyspnoea, bradyarrhythmia, analysed by patient demographic characteristic and by treatment

    Time frame: from baseline to 4 years

  5. Factors which may affect incidence of cardiovascular events, analysed by patient demographic characteristic and by treatment

    Time frame: from baseline to 4 years

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

Brilinta Tablets 60mg/90mg Clinical Experience Investigation

Acronym: BRLCEIACS/OMI

Important dates

Study start
2017
Primary completion
2024
Study completion
2024
First posted
Jul 11, 2017
Registry last updated
Jul 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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