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Brilinta Clinical Experience Investigation

NCT03212287 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 663

Last updated 2025-07-16

No results posted yet for this study

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. 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

Conditions

  • Acute Coronary Syndrome, Old Myocardial Infarction

Sponsors & Collaborators

Eligibility

Min Age
16 Years
Max Age
130 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-21
Primary Completion
2024-07-31
Completion
2024-07-31

Countries

  • Japan

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03212287 on ClinicalTrials.gov