NCT01870921: DaYu

Brilinta DaYu Study

Completed Phase 4 Results posted Last updated 3 April 2018

What this trial tests

Phase 4 trial testing Ticagrelor in Acute Coronary Syndrome in 2,004 participants. Completed in 30 September 2015.

Timeline

26 June 2013

Primary endpoint
30 September 2015

30 September 2015

Quick facts

Lead sponsor	AstraZeneca
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	2,004
Start date	26 June 2013
Primary completion	30 September 2015
Estimated completion	30 September 2015
Sites	39 locations across China

Drugs / interventions tested

• Ticagrelor (ticagrelor) — full drug profile →

Conditions studied

• Acute Coronary Syndrome — all drugs for Acute Coronary Syndrome →

Sponsor

AstraZeneca — full company profile →

Who can join

Adults 18 to 130, any sex, with Acute Coronary Syndrome. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Bleeding Events Primary · 12 months

PLATO-defined fatal/life threatening, major, major+minor,major+minor+minimal

Fatal/life threatening

Group	Value	95% CI
Ticargrelor	17

Major

Group	Value	95% CI
Ticargrelor	27

Major + minor

Group	Value	95% CI
Ticargrelor	93

Major + minor + minimal

Group	Value	95% CI
Ticargrelor	426

Serious Adverse Events Other Than Bleeding Primary · 12 months

SAEs except the blending events which have aleady been reported as SAEs.

Group	Value	95% CI
Ticargrelor	116

Major CV Events Secondary · 12 months

Combination of CV death, MI, and stroke

Group	Value	95% CI
Ticargrelor	85

Adverse events — posted to ClinicalTrials.gov

Time frame: From day of first dose to the day of last dose + 7 days, up to 1 year.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Ticargrelor

Serious: 161/2001 (8%)

Deaths: —

Serious adverse events (109 terms)

Reaction	System	Ticargrelor
Upper Gastrointestinal Haemorrhage	Gastrointestinal disorders	—
Gastrointestinal Haemorrhage	Gastrointestinal disorders	—
Chest Discomfort	General disorders	—
Cardiac Failure	Cardiac disorders	—
Gastritis	Gastrointestinal disorders	—
Lung Infection	Infections and infestations	—
Chronic Kidney Disease	Renal and urinary disorders	—
Haematuria	Renal and urinary disorders	—
Cerebral Haemorrhage	Nervous system disorders	—
Intervertebral Disc Protrusion	Musculoskeletal and connective tissue disorders	—
Diabetes Mellitus Inadequate Control	Metabolism and nutrition disorders	—
Duodenal Ulcer Haemorrhage	Gastrointestinal disorders	—
Acute Left Ventricular Failure	Cardiac disorders	—
Cardiac Failure Chronic	Cardiac disorders	—
Pneumonia	Infections and infestations	—
Subarachnoid Haemorrhage	Nervous system disorders	—
Sudden Death	General disorders	—
Gastric Ulcer Haemorrhage	Gastrointestinal disorders	—
Appendicitis	Infections and infestations	—
Urinary Tract Infection	Infections and infestations	—
Chronic Obstructive Pulmonary Disease	Respiratory, thoracic and mediastinal disorders	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—
Epistaxis	Respiratory, thoracic and mediastinal disorders	—
Gouty Arthritis	Musculoskeletal and connective tissue disorders	—
Road Traffic Accident	Injury, poisoning and procedural complications	—

Other adverse events (2 terms — click to expand)

Reaction	System	Ticargrelor
Hyperuricaemia	Metabolism and nutrition disorders	—
Ecchymosis	Skin and subcutaneous tissue disorders	—

Most-reported serious reactions: Upper Gastrointestinal Haemorrhage, Gastrointestinal Haemorrhage, Chest Discomfort, Cardiac Failure, Gastritis, Lung Infection, Chronic Kidney Disease, Haematuria.

Data from ClinicalTrials.gov NCT01870921 adverse events section.

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Safety and Incidence of Cardiovascular Events in Chinese Patients with Acute Coronary Syndrome Treated with Ticagrelor: the 12-Month, Phase IV, Multicenter, Single-Arm DAYU Study.
   Gao R, Wu Y, Liu H, Su G, et al · · 2018 · cited 7× · PMID 29488142 · DOI 10.1007/s10557-018-6772-3