Phase 4
Completed N=2,004
Brilinta DaYu Study
Source: ClinicalTrials.gov NCT01870921 ↗Enrolled (actual)
2,004
Serious AEs
8.1%
Results posted
Nov 2016
Primary outcomePrimary: Bleeding Events — 17; 27; 93; 426 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 This can indicate results are unpublished — a known publication-bias signal.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 incidence of major cardiovascular events of ticagrelor in Chinese patients with acute coronary syndrome
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Bleeding Events |
17; 27; 93; 426 | — |
| PRIMARY Serious Adverse Events Other Than Bleeding |
116 | — |
| SECONDARY Major CV Events |
85 | — |
Eligibility Criteria
Inclusion Criteria
- 1. Female or male aged at least 18 years 2.Index event of non-ST or ST segment elevation ACS 3.A patient who is considered as ethnic Chinese
Exclusion Criteria
- 1. With coagulation disorder 2.Index event is an acute complication of PCI 3.Patient has planned for an urgent coronary artery bypass graft (CABG) within 7days from the enrolment 4.Oral anticoagulation therapy within 30 days prior to enrolment or cannot be stopped 5.Increased risk of bradycardic events 6. Concomitant oral or intravenous therapy (see examples below) with strong CYP3A inhibitors, CYP3A substrates with narrow therapeutic indices, or strong CYP3A inducers 7.Increased risk of bradycardic events (eg, no pacemaker and known sick sinus syndrome, second degree A-V block, third degree A-V block or previous documented syncope suspected to be due to bradycardia unless treated with a pacemaker). 8.Known clinically important thrombocytopenia 9.Known clinically important anaemia
Data sourced from ClinicalTrials.gov (NCT01870921). 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.