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

Study Overview
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Brief Summary
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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.

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

Conditions
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Acute Coronary Syndrome

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Part A<br>PATIENTS RECEIVED THE STANDARD MEDICAL CARE AS DETERMINED BY THE TREATING CARDIOLOGIST | |
| Part B<br>Patients on ticagrelor at the time of discharge from hospital | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Patients included in Federal ACS Registry from 1st Jan of 2012 till 1st March of 2015 | 1st Jan of 2012-1st 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) | During follow up | Up to 2 years | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Coronary Syndrome, Russian ACS Registry, ticagrelor