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

Sponsor
AstraZeneca (Industry)
Overall Status
Completed
CT.gov ID
NCT02288260
Collaborator
(none)
5,470
Enrollment
15
Locations
39.5
Actual Duration (Months)
364.7
Patients Per Site
9.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    5470 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    RuSsian RegisTry of Acute CoronaRy SyndromE TreAtMent and Approach in Dual Antiplatelet Therapy (STREAM)
    Actual Study Start Date :
    Apr 13, 2015
    Actual Primary Completion Date :
    Jul 29, 2018
    Actual Study Completion Date :
    Jul 29, 2018

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    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) [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) [Up to 2 years]

      During follow up

    Secondary Outcome Measures

    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) [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) [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) [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) [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) [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) [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) [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) [Up to 2 years]

      During follow-up period

    9. Proportion of patients who discontinued ticagrelor and reason to discontinue ticagrelor treatment. (Part B) [Up to 2 years]

      during follow-up period

    10. Proportion of patients with significant violations of treatment regimen with ticagrelor. (Part B) [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) [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) [Up to 2 years]

      during follow-up period

    13. Proportion of patients who change DAT components and reason to change of DAT. (Part B) [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) [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) [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) [Up to 2 years]

      during follow-up period

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Research Site Arkhangelsk Russian Federation
    2 Research Site Cheboksary Russian Federation
    3 Research Site Irkutsk Russian Federation
    4 Research Site Kazan Russian Federation
    5 Research Site Kemerovo Russian Federation
    6 Research Site Moscow Russian Federation
    7 Research Site Novosibirsk Russian Federation
    8 Research Site Petrozavodsk Russian Federation
    9 Research Site Ryazan Russian Federation
    10 Research Site Saint-Petersburg Russian Federation
    11 Research Site Stavropol Russian Federation
    12 Research Site Tomsk Russian Federation
    13 Research Site Tyumen Russian Federation
    14 Research Site Ufa Russian Federation
    15 Research Site Vladivostok Russian Federation

    Sponsors and Collaborators

    • AstraZeneca

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    AstraZeneca
    ClinicalTrials.gov Identifier:
    NCT02288260
    Other Study ID Numbers:
    • D1843R00242
    First Posted:
    Nov 11, 2014
    Last Update Posted:
    Jul 15, 2019
    Last Verified:
    Jul 1, 2019
    Keywords provided by AstraZeneca
    Acute Coronary Syndrome
    Russian ACS Registry
    ticagrelor
    Additional relevant MeSH terms:
    Acute Coronary Syndrome
    Syndrome

    Study Results

    No Results Posted as of Jul 15, 2019