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

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

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.

Study Overview

• Status: Completed
• Conditions: Acute Coronary Syndrome

• Study Type: Observational
• Enrollment (Actual): 5470

Contacts and Locations

Study Locations

• Russian Federation
  • Arkhangelsk, Russian Federation
    • Research Site
  • Cheboksary, Russian Federation
    • Research Site
  • Irkutsk, Russian Federation
    • Research Site
  • Kazan, Russian Federation
    • Research Site
  • Kemerovo, Russian Federation
    • Research Site
  • Moscow, Russian Federation
    • Research Site
  • Novosibirsk, Russian Federation
    • Research Site
  • Petrozavodsk, Russian Federation
    • Research Site
  • Ryazan, Russian Federation
    • Research Site
  • Saint-Petersburg, Russian Federation
    • Research Site
  • Stavropol, Russian Federation
    • Research Site
  • Tomsk, Russian Federation
    • Research Site
  • Tyumen, Russian Federation
    • Research Site
  • Ufa, Russian Federation
    • Research Site
  • Vladivostok, Russian Federation
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Study includes patients, in a real-life setting, who are hospitalized for acute coronary syndrome (ACS) within 24 hours of symptom onset and who have a final diagnosis of Unstable Angina (UA), Myocardial Infarction (MI) and were discharged. Including transferred to another medical institution after 24 hours from the moment of hospitalization; transferred from other medical institutions within 24 hours from the moment of initial hospitalization to hospital.

Principal of choice in the Single-cohort study: only patients with ticagrelor at discharged.

Patients received the standard medical care as determined by the treating cardiologist.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Part A; PATIENTS RECEIVED THE STANDARD MEDICAL CARE AS DETERMINED BY THE TREATING CARDIOLOGIST
Part B; Patients on ticagrelor at the time of discharge from hospital

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Study Director: Vladimir Bulatov, MCMD, AstraZeneca; Principal Investigator: Eleva Oschepkova, MD, PROFESSOR OF CARDIOLOGY, Russian Cardiology Research and Production Complex

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): April 13, 2015
• Primary Completion (Actual): July 29, 2018
• Study Completion (Actual): July 29, 2018

Study Registration Dates

• First Submitted: November 7, 2014
• First Submitted That Met QC Criteria: November 7, 2014
• First Posted (Estimate): November 11, 2014

Study Record Updates

• Last Update Posted (Actual): July 15, 2019
• Last Update Submitted That Met QC Criteria: July 12, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: ticagrelor; Acute Coronary Syndrome; Russian ACS Registry
• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Disease; Syndrome; Acute Coronary Syndrome
• Other Study ID Numbers: D1843R00242