跳至主要内容
临床试验/NCT02288260
NCT02288260已完成不适用

RuSsian RegisTry of Acute CoronaRy SyndromE TreAtMent and Approach in Dual Antiplatelet Therapy (STREAM)

AstraZeneca1 个研究点 分布在 1 个国家目标入组 5,470 人开始时间: 2015年4月13日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
AstraZeneca
入组人数
5,470
试验地点
1
主要终点
Proportion of patients receiving different types of short-term antithrombotic treatment according to different type of acute coronary syndrome (STEMI - ST-elevation myocardial infarction, NSTE(Non-ST-elevation)-ACS and Unstable Angina). (Part A)

研究概览

简要总结

This NIS is a multi-centre, observational, descriptive, cross-sectional study including all consecutive patients with Acute Coronary Syndrome (ACS) and a single-arm, prospective, longitudinal cohort study which will include patients hospitalized for ACS and who are with ticagrelor on discharge from hospital.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

性别
All
接受健康志愿者

入选标准

  • Part A,B: Subjects whose data have been entered in the Russian ACS Registry
  • PART A,B: Discharged from hospital after MI with ST-segment elevation (STEMI), MI NST segment elevation (NSTEMI) or Unstable angina. Hospitalized during 24 hours of ACS symptoms onset
  • Part B: Patients on ticagrelor at the time of discharge from hospital

排除标准

  • The existence of serious / severe concomitant diseases which can in the short term (i.e. within 6 months) limit the duration of life
  • Current participation in a clinical trial with a non-licensed investigational medicinal product

结局指标

主要结局

Proportion of patients receiving different types of short-term antithrombotic treatment according to different type of acute coronary syndrome (STEMI - ST-elevation myocardial infarction, NSTE(Non-ST-elevation)-ACS and Unstable Angina). (Part A)

时间窗: 1st Jan of 2012-1st March of 2015

Patients included in Federal ACS Registry from 1st Jan of 2012 till 1st March of 2015

Proportion of patients taking ticagrelor with cardiovascular (CV) events after discharge from hospital depending on DAT (Dual Antiplatelet Therapy) duration. (Part B)

时间窗: Up to 2 years

During follow up

次要结局

  • Proportion of patients who undergo invasive or non-invasive short-term clinical management according to different type of acute coronary syndrome (STEMI, NSTE-ACS and Unstable Angina). (Part A)(1st Jan of 2012-1st March of 2015)
  • Time from first symptoms onset to the time of hospitalization (Part A)(1st Jan of 2012-1st March of 2015)
  • Proportion of patients receiving different types of ACS treatment depending on ACS symptoms duration prior hospitalization. (Part A)(1st Jan of 2012-1st March of 2015)
  • Patients demographic and baseline characteristics (age, gender, weight, height). (Part A)(1st Jan of 2012-1st March of 2015)
  • Proportion of patients with different type of coronary intervention strategies. (Part A)(1st Jan of 2012-1st March of 2015)
  • Proportion of patients who is on ticagrelor treatment during 0-3 months, >3-6 months, >6-9 months, >9-12 months. (Part B)(Up to 2 years)
  • Proportion of patients with ticagrelor treatment interruptions according to different clinical and non-clinical events (bleeds, planned and non-planned medical interventions, etc.) during follow-up. (Part B)(Up to 2 years)
  • Proportion of patients with thrombo-embolic events during follow-up depending on DAT therapy duration. (Part B)(Up to 2 years)
  • Proportion of patients who discontinued ticagrelor and reason to discontinue ticagrelor treatment. (Part B)(Up to 2 years)
  • Proportion of patients with significant violations of treatment regimen with ticagrelor. (Part B)(Up to 2 years)
  • Start and stop dates of dual antipatelet therapy and ticagrelor (as part of DAT) and duration of exposure to DAT and ticagrelor in real-life setting. (Part B)(Up to 2 years)
  • Proportion of patients who discontinued DAT and the reason of discontinuation of DAT in real-life setting. (Part B)(Up to 2 years)
  • Proportion of patients who change DAT components and reason to change of DAT. (Part B)(Up to 2 years)
  • Proportion of patients with CV-events (recurrent Myocardial Infarction-MI, stroke, ischemia-driven revascularization, death, etc.) in long-term perspective (second year) after index event in real-life setting. (Part B)(Up to 2 years)
  • Proportion of patients using different type of antithrombotic therapy in long-term perspective (second year) after index event. (Part B)(Up to 2 years)
  • Proportion of patients who managed by cardiologist, therapist and other physician after discharge from the hospital. (Part B)(Up to 2 years)

研究者

发起方
AstraZeneca
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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