Acute Coronary SyndromePhase 4DaYuNCT01870921

Brilinta DaYu Study

A Phase 4 study testing Ticagrelor in people with Acute Coronary Syndrome, run by AstraZeneca at 39 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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 Read more about this study

Who is it for?: Ages 18 to 130 years
Conditions the study is for: Acute Coronary Syndrome
What is being tested?: Ticagrelor
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2,004 participants
Where: 39 sitesChina
Study dates: 26 Jun 2013to 30 Sep 2015
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 130 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

39 sites in 1 country.

City, postcode or hospital

39 sites in 1 country

China39 sites

Research Site
Beijing, 100006
Research Site
Beijing, 100029
Research Site
Beijing, 100037
Research Site
Beijing, 100050
Research Site
Beijing, 100083
Research Site
Beijing, 100730
Research Site
Changchun, 130021
Research Site
Chengdu, 610041
Research Site
Chuangchun, 130041
Research Site
Fuzhou, 350001
Research Site
Fuzhou
Research Site
Guangzhou, 510080
Research Site
Guangzhou, 510220
Research Site
Jinan, 250012
Research Site
Jinan, 250021
Research Site
Jinan, 250033
Research Site
Jining, 272011
Research Site
Kunming, 650032
Research Site
Nanjing, 210009
Research Site
Nanjing, 210012
Research Site
Nanjing, 210029
Research Site
Shanghai, 200025
Research Site
Shanghai, 200433
Research Site
Shanghai
Research Site
Shenyang, 110001
Research Site
Shenyang, 110016
Research Site
Shenzhen, 518003
Research Site
Shenzhen, 518020
Research Site
Shenzhen, 518036
Research Site
Taiyuan, 030001
Research Site
Wuhan, CN-430022
Research Site
Wuxi, 214023
Research Site
Xi'an, 710032
Research Site
Xi'an, 710061
Research Site
Xiamen, 361004
Research Site
Xuzhou, 221006
Research Site
Zhengzhou, 450000
Research Site
Zhengzhou, 450012
Research Site
Zhongshan, 528403

Other trials in China

About this study

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)

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

Conditions: Acute Coronary Syndrome
Being tested: Ticagrelor
Medical subject headings: Acute Coronary Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TicagrelorDrug
90mg/tablet, 1 tablet bid

Study groups in NCT01870921
Study group	Role	What they receive
Ticargrelor	Experimental	90 mg/tablet, 1 tablet bid Receives: Drug: Ticagrelor

What is being measured

The primary outcome is the main question the study is designed to answer.

Bleeding Events
PLATO-defined fatal/life threatening, major, major+minor,major+minor+minimal
Measured: 12 months
Serious Adverse Events Other Than Bleeding
SAEs except the blending events which have aleady been reported as SAEs.
Measured: 12 months

Secondary outcomes (1)

Major CV Events
Combination of CV death, MI, and stroke
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Jun 201330 Sep 2015

First posted6 Jun 2013 (estimated)
Study start26 Jun 2013
Primary completion30 Sep 2015
Study completion30 Sep 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 2,004 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01870921
Sponsor's protocol ID: D5130C00087
Acronym: DaYu
Status last verified: Mar 2018
First submitted: 4 Jun 2013
Last updated: 3 Apr 2018
Results posted: Yes, on ClinicalTrials.gov

Publications

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.
PubMed 29488142

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingObservational study
Prognostic Value of Functional-Nutritional Status in Older Adults With Acute Coronary Syndrome
Acute Coronary Syndromes (ACS)
RecruitingPhase 4
Early Initiation of Tafolecimab for Patients With Acute Coronary Syndromeundergoing Percutaneous Coronary Intervention in Chinese Population
Acute Coronary Syndrome, Non ST Segment Elevation Acute Coronary Syndrome
Active, not recruiting
Safety and Clinical Performance of the Freesolve Resorbable Magnesium Scaffold System in the Treatment of Subjects With Long de Novo Lesions
Coronary Artery Disease, Atherosclerosis of Coronary Artery
Active, not recruiting
Interventional Strategy for Non-culprit Lesions With Major Vulnerability Criteria at OCT in Patients With ACS
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All Acute Coronary Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT01870921
Acronym / sponsor ID: DaYu / D5130C00087
Conditions: Acute Coronary Syndrome
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 2,004 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 26 Jun 2013 (actual)
Primary completion: 30 Sep 2015 (actual)
Study completion: 30 Sep 2015 (actual)
First posted: 6 Jun 2013 (estimated)
Results: Posted 9 Nov 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Ticargrelor	Experimental	Drug: Ticagrelor90 mg/tablet, 1 tablet bid

Who may qualify

Ages: 18 to 130 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Ticagrelor90mg/tablet, 1 tablet bid	Drug	Ticargrelor

Primary outcome

Bleeding Events
Time frame: 12 months
PLATO-defined fatal/life threatening, major, major+minor,major+minor+minimal
Serious Adverse Events Other Than Bleeding
Time frame: 12 months
SAEs except the blending events which have aleady been reported as SAEs.

1 secondary outcome

Major CV Events
Time frame: 12 months

Results and safety

Results posted to the registry on 9 Nov 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ticargrelor	2,004	1,914

Primary outcome: Bleeding Events

Time frame: 12 months. Number. Unit: Participants

Measure	Ticargrelor n = 2001
Fatal/life threatening	17
Major	27
Major + minor	93
Major + minor + minimal	426

Primary outcome: Serious Adverse Events Other Than Bleeding

Time frame: 12 months. Number. Unit: Participants

Measure	Ticargrelor n = 2001
Value	116

1 secondary outcome is reported in the full results.

Adverse events

Time frame: From day of first dose to the day of last dose + 7 days, up to 1 year.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ticargrelor	161 of 2,001 (8%)	230 of 2,001 (11.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 29488142Gao 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.
D5130C00087 Clinical Study Protocol and amendment redactedLink provided by the sponsor.

Related trials for Acute Coronary Syndrome

Not yet recruitingObservational study
Prognostic Value of Functional-Nutritional Status in Older Adults With Acute Coronary Syndrome
Acute Coronary Syndromes (ACS)
RecruitingPhase 4
Early Initiation of Tafolecimab for Patients With Acute Coronary Syndromeundergoing Percutaneous Coronary Intervention in Chinese Population
Acute Coronary Syndrome, Non ST Segment Elevation Acute Coronary Syndrome
Active, not recruiting
Safety and Clinical Performance of the Freesolve Resorbable Magnesium Scaffold System in the Treatment of Subjects With Long de Novo Lesions
Coronary Artery Disease, Atherosclerosis of Coronary Artery
Active, not recruiting
Interventional Strategy for Non-culprit Lesions With Major Vulnerability Criteria at OCT in Patients With ACS
Coronary Artery Disease, Coronary Disease
Active, not recruiting
Point-of-Care Troponin Testing in the Emergency Department
Acute Coronary Syndromes

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Runlin Gao, Doctor principal investigator

Fu Wai Hospital, Beijing, China

39 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ticagrelor in people with Acute Coronary Syndrome, run by AstraZeneca at 39 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 39 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Nov 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Bleeding Events (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01870921, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2018.