RuSsian RegisTry of Acute CoronaRy SyndromE TreAtMent and Approach in Dual Antiplatelet Therapy
STREAM
1 other identifier
observational
5,470
1 country
15
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2015
Typical duration for all trials
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 7, 2014
CompletedFirst Posted
Study publicly available on registry
November 11, 2014
CompletedStudy Start
First participant enrolled
April 13, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 29, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 29, 2018
CompletedJuly 15, 2019
July 1, 2019
3.3 years
November 7, 2014
July 12, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (16)
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
Time from first symptoms onset to the time of hospitalization (Part A)
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)
1st Jan of 2012-1st March of 2015
Patients demographic and baseline characteristics (age, gender, weight, height). (Part A)
1st Jan of 2012-1st March of 2015
Proportion of patients with different type of coronary intervention strategies. (Part A)
1st Jan of 2012-1st March of 2015
- +11 more secondary outcomes
Study Arms (2)
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
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (15)
Research Site
Arkhangelsk, Russia
Research Site
Cheboksary, Russia
Research Site
Irkutsk, Russia
Research Site
Kazan', Russia
Research Site
Kemerovo, Russia
Research Site
Moscow, Russia
Research Site
Novosibirsk, Russia
Research Site
Petrozavodsk, Russia
Research Site
Ryazan, Russia
Research Site
Saint Petersburg, Russia
Research Site
Stavropol, Russia
Research Site
Tomsk, Russia
Research Site
Tyumen, Russia
Research Site
Ufa, Russia
Research Site
Vladivostok, Russia
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Vladimir Bulatov, MCMD
AstraZeneca
- PRINCIPAL INVESTIGATOR
Eleva Oschepkova, MD, PROFESSOR OF CARDIOLOGY
Russian Cardiology Research and Production Complex
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Target Duration
- 2 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 7, 2014
First Posted
November 11, 2014
Study Start
April 13, 2015
Primary Completion
July 29, 2018
Study Completion
July 29, 2018
Last Updated
July 15, 2019
Record last verified: 2019-07