Clinical Trial: RuSsian RegisTry of Acute CoronaRy SyndromE TreAtMent and Approach in Dual Antiplatelet Therapy

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational [Patient Registry]

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

Brief Summary: 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.

Detailed Summary:
Sponsor: AstraZeneca

Current Primary Outcome:

• 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) [ Time Frame: 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) [ Time Frame: Up to 2 years ]
  During follow up

Original Primary Outcome:

• 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) [ Time Frame: up to 9 months ]
• Proportion of patients taking ticagrelor with cardiovascular (CV) events after discharge from hospital depending on DAT (Dual Antiplatelet Therapy) duration. (Part B) [ Time Frame: up to 33 months ]

Current Secondary Outcome:

• 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) [ Time Frame: 1st Jan of 2012-1st March of 2015 ]
  Patients included in Federal ACS Registry from 1st Jan of 2012 till 1st March of 2015
• Time from first symptoms onset to the time of hospitalization (Part A) [ Time Frame: 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 receiving different types of ACS treatment depending on ACS symptoms duration prior hospitalization. (Part A) [ Time Frame: 1st Jan of 2012-1st March of 2015 ]
  Patients included in Federal ACS Registry from 1st Jan of 2012 till 1st March of 2015
• Patients demographic and baseline characteristics (age, gender, weight, height). (Part A) [ Time Frame: 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 with different type of coronary intervention strategies. (Part A) [ Time Frame: 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 who is on ticagrelor treatment during 0-3 months, >3-6 months, >6-9 months, >9-12 months. (Part B) [ Time Frame: Up to 2 years ]
  During follow up
• 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) [ Time Frame: Up to 2 years ]
  During follow-up period
• Proportion of patients with thrombo-embolic events during follow-up depending on DAT therapy duration. (Part B) [ Time Frame: Up to 2 years ]
  During follow-up period
• Proportion of patients who discontinued ticagrelor and reason to discontinue ticagrelor treatment. (Part B) [ Time Frame: Up to 2 years ]
  during follow-up period
• Proportion of patients with significant violations of treatment regimen with ticagrelor. (Part B) [ Time Frame: Up to 2 years ]
  during follow-up period
• 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) [ Time Frame: Up to 2 years ]
  during follow-up period
• Proportion of patients who discontinued DAT and the reason of discontinuation of DAT in real-life setting. (Part B) [ Time Frame: Up to 2 years ]
  during follow-up period
• Proportion of patients who change DAT components and reason to change of DAT. (Part B) [ Time Frame: Up to 2 years ]
  during follow-up period
• 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) [ Time Frame: Up to 2 years ]
  during follow-up period
• Proportion of patients using different type of antithrombotic therapy in long-term perspective (second year) after index event. (Part B) [ Time Frame: Up to 2 years ]
  during follow-up period
• Proportion of patients who managed by cardiologist, therapist and other physician after discharge from the hospital. (Part B) [ Time Frame: Up to 2 years ]
  during follow-up period

Original Secondary Outcome:

• 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) [ Time Frame: up to 9 months ]
• Time from first symptoms onset to the time of hospitalization (Part A) [ Time Frame: up to 9 months ]
• Proportion of patients receiving different types of ACS treatment depending on ACS symptoms duration prior hospitalization. (Part A) [ Time Frame: up to 9 months ]
• Patients demographic and baseline characteristics (age, gender, weight, height). (Part A) [ Time Frame: up to 9 months ]
• Proportion of patients with different type of coronary intervention strategies. (Part A) [ Time Frame: up to 9 months ]
• Proportion of patients who is on ticagrelor treatment during 0-3 months, >3-6 months, >6-9 months, >9-12 months. (Part B) [ Time Frame: up to 33 months ]
• 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) [ Time Frame: up to 33 months ]
• Proportion of patients with thrombo-embolic events during follow-up depending on DAT therapy duration. (Part B) [ Time Frame: up to 33 months ]
• Proportion of patients who discontinued ticagrelor and reason to discontinue ticagrelor treatment. (Part B) [ Time Frame: up to 33 months ]
• Proportion of patients with significant violations of treatment regimen with ticagrelor. (Part B) [ Time Frame: up to 33 months ]
• 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) [ Time Frame: up to 33 months ]
• Proportion of patients who discontinued DAT and the reason of discontinuation of DAT in real-life setting. (Part B) [ Time Frame: up to 33 months ]
• Proportion of patients who change DAT components and reason to change of DAT. (Part B) [ Time Frame: up to 33 months ]
• 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) [ Time Frame: up to 33 months ]
• Proportion of patients using different type of antithrombotic therapy in long-term perspective (second year) after index event. (Part B) [ Time Frame: up to 33 months ]
• Proportion of patients who managed by cardiologist, therapist and other physician after discharge from the hospital. (Part B) [ Time Frame: up to 33 months ]

Information By: AstraZeneca

Dates:
Date Received: November 7, 2014
Date Started: April 2015
Date Completion: July 30, 2018
Last Updated: May 19, 2017
Last Verified: May 2017