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NCT Number: NCT02288260

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

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.

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Key information

Conditions

Acute Coronary Syndrome Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Arkhangelsk, Russia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. Proportion of patients who discontinued ticagrelor and reason to discontinue ticagrelor treatment. (Part B)

    Time frame: Up to 2 years

    during follow-up period

  10. Proportion of patients with significant violations of treatment regimen with ticagrelor. (Part B)

    Time frame: Up to 2 years

    during follow-up period

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Acronym: STREAM

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Nov 11, 2014
Registry last updated
Jul 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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