Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Brilinta DaYu Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01870921
First received: June 4, 2013
Last updated: November 7, 2014
Last verified: October 2014

June 4, 2013
November 7, 2014
June 2013
October 2015   (final data collection date for primary outcome measure)
  • Cardiovascular(CV) death [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    The total number of CV death event will be recorded
  • Myocardial infarction (MI) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    The total number of MI event will be recorded
Same as current
Complete list of historical versions of study NCT01870921 on ClinicalTrials.gov Archive Site
total major bleed [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
The total number of major bleeding event will be recorded
Same as current
Not Provided
Not Provided
 
Brilinta DaYu Study
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

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Acute Coronary Syndrome
Drug: Ticagrelor
90mg/tablet, 1 tablet bid
Experimental: Ticargrelor
90 mg/tablet, 1 tablet bid
Intervention: Drug: Ticagrelor
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
2000
October 2015
October 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01870921
D5130C00087
Not Provided
AstraZeneca
AstraZeneca
Not Provided
Principal Investigator: Runlin Gao, Doctor Beijing Fuwai Hospital
AstraZeneca
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP