Brilinta DaYu Study

Acute Coronary Syndrome Clinical Trial

— DaYu  

Official title:

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(ACS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01870921
• Other study ID #: D5130C00087
• Status: Completed
• Phase: Phase 4
• First received: June 4, 2013
• Last updated: March 7, 2018
• Start date: June 26, 2013
• Est. completion date: September 30, 2015

Study information

• Verified date: March 2018
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2004
• Est. completion date: September 30, 2015
• Est. primary completion date: September 30, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 130 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Intervention

Drug:
• Ticagrelor
90mg/tablet, 1 tablet bid

Locations

Country	Name	City	State
China	Research Site	Beijing
China	Research Site	Beijing
China	Research Site	Beijing
China	Research Site	Beijing
China	Research Site	Beijing
China	Research Site	Beijing
China	Research Site	Changchun
China	Research Site	Chengdu
China	Research Site	Chuangchun
China	Research Site	Fuzhou
China	Research Site	Fuzhou
China	Research Site	Guangzhou
China	Research Site	Guangzhou
China	Research Site	Jinan
China	Research Site	Jinan
China	Research Site	Jinan
China	Research Site	Jining
China	Research Site	Kunming
China	Research Site	Nanjing
China	Research Site	Nanjing
China	Research Site	Nanjing
China	Research Site	Shanghai
China	Research Site	Shanghai
China	Research Site	Shanghai
China	Research Site	Shenyang
China	Research Site	Shenyang
China	Research Site	Shenzhen
China	Research Site	Shenzhen
China	Research Site	Shenzhen
China	Research Site	Taiyuan
China	Research Site	Wuhan
China	Research Site	Wuxi
China	Research Site	Xiamen
China	Research Site	Xian
China	Research Site	Xian
China	Research Site	Xuzhou
China	Research Site	Zhengzhou
China	Research Site	Zhengzhou
China	Research Site	Zhongshan

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

China, 

References & Publications (1)

Gao R, Wu Y, Liu H, Su G, Yuan Z, Zhang A, Wang Y, Wang Z, Wang Y, Zhang H, Zheng Y, Liu L, Shen L, Leonsson-Zachrisson M, Han Y; DAYU study investigators. 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. Cardiovasc Drugs Ther. 2018 Feb;32(1):47-56. doi: 10.1007/s10557-018-6772-3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bleeding Events	PLATO-defined fatal/life threatening, major, major+minor,major+minor+minimal	12 months
Primary	Serious Adverse Events Other Than Bleeding	SAEs except the blending events which have aleady been reported as SAEs.	12 months
Secondary	Major CV Events	Combination of CV death, MI, and stroke	12 months

External Links

•   D5130C00087 Clinical Study Protocol and amendment redacted