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临床试验/NCT02521038
NCT02521038Unknown不适用

The Use of BRILInta to Optimize ANTiplatelet Therapy (BRILIANT) Registry: The BRILIANT KOREA Registry

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2015年7月最近更新:
适应症

试验速览

阶段
不适用
入组人数
2,000
试验地点
1
主要终点
Number of participants with 'Major Adverse Cardiovascular endpoints'

研究概览

简要总结

Patients with acute coronary syndrome (ACS) require platelet inhibition after treatment. P2Y12 receptor blockage is a well-known, proved method of urgent and effective blockade of the platelet activation, and is applied to the current practice protocol. Ticagrelor is a well-performing P2Y12 receptor blocking agent which is used in these patients. In the same matter, it is essential to prescribe the exact dosage to optimize efficacy within the safety limits. However current studies are based on Western countries, whereas there has been no Ticagrelor patient registry in East-Asia. Thus it is reasonable to study the use of Ticagrelor in a large registry of Korean ACS patients.

The BK registry is a Prospective, Open-label, Multi-center, Real world, Registry, with prospective registration of patients receiving the medication, Ticagrelor. All subjects are to be followed up for 18 months after diagnosis and treatment for ACS.

The purpose of this study is to observe and register clinical data including Major Adverse Cardiovascular Endpoints and any total bleeding occurrence in Korean ACS patients treated with Ticagrelor during 18 month follow-up. Also, the purpose includes to determine compliance of Ticagrelor during post-approval commercial use and to determine prescription pattern of Ticagrelor during post-approval commercial use.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Provision of informed consent prior to any study specific procedures. Alternatively, a legally authorized patient representative may agree to the patient's participation in this study and sign the informed consent form.
  • Patients who are taking ticagrelor and acetylsalicylic acid daily or Patients who are taking ticagrelor only according to label. All treatment modalities for Acute coronary syndrome (invasive and non-invasive) are allowed.

排除标准

  • 未提供

结局指标

主要结局

Number of participants with 'Major Adverse Cardiovascular endpoints'

时间窗: 18 months

'Major Adverse Cardiovascular endpoints' assessment will be recorded as number of participants with 'Major Adverse Cardiovascular endpoints'. This measure is a composite outcome, which includes cardiovascular death, myocardial infarction, stroke, stent thrombosis.

Number of participants with Bleeding events

时间窗: 18 months

Bleeding event assessment will be recorded as number of participants with Bleeding events. Assessment will be done by the investigator(s) at each routine out-patient follow-up period. Bleeding events will be analyzed according to the 'PLATO bleeding criteria'.

次要结局

  • Compliance of Brilinta(12 months)
  • Dosage of prescribed Brilinta(12 months)
  • Duration of prescribed Brilinta(12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hyo-Soo Kim

Professor

Seoul National University Hospital

研究点 (1)

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