Brilinta DaYu Study

This study is currently recruiting participants.
Verified February 2014 by AstraZeneca
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01870921
First received: June 4, 2013
Last updated: February 7, 2014
Last verified: February 2014
  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
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: 2500
Study Start Date: June 2013
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01870921

Contacts
Contact: Evan NA Zhang, Master +862160301217 ClinicalTrialTransparency@astrazeneca.com

Locations
China
Research Site Not yet recruiting
Beijing, China
Research Site Recruiting
Beijing, China
Research Site Not yet recruiting
Changchun, China
Research Site Recruiting
Chengdu, China
Research Site Not yet recruiting
Chuangchun, China
Research Site Not yet recruiting
Fuzhou, China
Research Site Recruiting
Guangzhou, China
Research Site Not yet recruiting
Guangzhou, China
Research Site Not yet recruiting
Hangzhou, China
Research Site Recruiting
Jinan, China
Research Site Not yet recruiting
Jinan, China
Research Site Recruiting
Jining, China
Research Site Not yet recruiting
Jining, China
Research Site Not yet recruiting
Kunming, China
Research Site Not yet recruiting
Linyi, China
Research Site Not yet recruiting
Nanjing, China
Research Site Recruiting
Nanjing, China
Research Site Withdrawn
Nanning, China
Research Site Withdrawn
Ningbo, China
Research Site Not yet recruiting
Qingdao, China
Research Site Not yet recruiting
Shanghai, China
Research Site Not yet recruiting
Shenyang, China
Research Site Recruiting
Shenyang, China
Research Site Not yet recruiting
Shenzhen, China
Research Site Not yet recruiting
Taiyuan, China
Research Site Not yet recruiting
Tianjin, China
Research Site Not yet recruiting
Wuhan, China
Research Site Not yet recruiting
Wulumuqi, China
Research Site Not yet recruiting
Wuxi, China
Research Site Recruiting
Xiamen, China
Research Site Recruiting
Xian, China
Research Site Not yet recruiting
Xian, China
Research Site Recruiting
Xuzhou, China
Research Site Not yet recruiting
Zhengzhou, China
Research Site Not yet recruiting
Zhongshan, China
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Runlin Gao, Doctor Beijing Fuwai Hospital
  More Information

Additional 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 7, 2014
Health Authority: Institution of Beijing Fuwai Hospital, China':'

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

ClinicalTrials.gov processed this record on April 17, 2014