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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: February 2, 2015
Last verified: February 2015
  Purpose

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


Condition Intervention Phase
Acute Coronary Syndrome
Drug: Ticagrelor
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • total major bleed [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    The total number of major bleeding event will be recorded


Estimated Enrollment: 2000
Study Start Date: June 2013
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ticargrelor
90 mg/tablet, 1 tablet bid
Drug: Ticagrelor
90mg/tablet, 1 tablet bid

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01870921

Locations
China
Research Site
Beijing, China
Research Site
Changchun, China
Research Site
Chengdu, China
Research Site
Chuangchun, China
Research Site
Fuzhou, China
Research Site
Guangzhou, China
Research Site
Jinan, China
Research Site
Jining, China
Research Site
Kunming, China
Research Site
Nanjing, China
Research Site
Shanghai, China
Research Site
Shenyang, 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
Xuzhou, China
Research Site
Zhengzhou, China
Research Site
Zhongshan, China
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Runlin Gao, Doctor Beijing Fuwai Hospital
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01870921     History of Changes
Other Study ID Numbers: D5130C00087
Study First Received: June 4, 2013
Last Updated: February 2, 2015
Health Authority: Institution of Beijing Fuwai Hospital, China':'

Additional relevant MeSH terms:
Acute Coronary Syndrome
Syndrome
Angina Pectoris
Cardiovascular Diseases
Chest Pain
Disease
Heart Diseases
Myocardial Ischemia
Pain
Pathologic Processes
Signs and Symptoms
Vascular Diseases
Ticagrelor
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Purinergic Agents
Purinergic Antagonists
Purinergic P2 Receptor Antagonists
Purinergic P2Y Receptor Antagonists

ClinicalTrials.gov processed this record on February 25, 2015