Phase 4
Completed N=108
Brilinta Taiwan Post Approval Safety Study
Source: ClinicalTrials.gov NCT02406248 ↗Enrolled (actual)
108
Serious AEs
21.3%
Results posted
Oct 2018
Primary outcomePrimary: Number of Participants With Fatal/Life-threatening Bleedings — 4 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
A multicenter, single arm, open label, Phase IV study to evaluate safety and to describe the cumulative incidence of major cardiovascular events of Ticagrelor in Taiwanese patients with non ST-segment (a segment in the eletrocardiogram which presents the period when ventricles are depolarized) elevation myocardial infarction
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Fatal/Life-threatening Bleedings |
4 | — |
| PRIMARY Number of Participants With Bleeding Events (Major Bleedings) |
7 | — |
| PRIMARY Number of Participants With Bleeding Events (Major and Minor Bleedings) |
20 | — |
| PRIMARY Number of Participants With Other Serious Adverse Event (SAEs) |
21 | — |
| PRIMARY Number of Participants With Major Cardiovascular Events |
6 | — |
Eligibility Criteria
Inclusion Criteria
- Provision of informed consent prior to any study specific procedures
- Female or male aged at least 20 years
- Patient who is considered as ethnic Taiwanese
- Index event of non-ST elevation myocardial infarction
Exclusion Criteria
- Contraindication or other reason that ticagrelor should not be administered
- Index event is an acute complication of Percutaneous coronary intervention (PCI)
- Patient has planned for an urgent coronary artery bypass graft (CABG) within 7 days from the enrolment
- Oral anticoagulation therapy within 30 days prior to enrolment or cannot be stopped
- Fibrinolytic therapy in the 24 hours prior to enrolment, or planned fibrinolytic treatment following enrolment
Data sourced from ClinicalTrials.gov (NCT02406248). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.