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

AstraZeneca1 site in 1 country5,470 target enrollmentApril 13, 2015

ConditionsAcute Coronary Syndrome

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Acute Coronary Syndrome
Sponsor: AstraZeneca
Enrollment: 5470
Locations: 1
Primary Endpoint: 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)
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 13, 2015

End Date

July 29, 2018

Last Updated

6 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

AstraZeneca

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

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

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)
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)
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)
Proportion of patients with thrombo-embolic events during follow-up depending on DAT therapy duration. (Part B)(Up to 2 years)
Proportion of patients who discontinued ticagrelor and reason to discontinue ticagrelor treatment. (Part B)(Up to 2 years)
Proportion of patients with significant violations of treatment regimen with ticagrelor. (Part B)(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)(Up to 2 years)
Proportion of patients who discontinued DAT and the reason of discontinuation of DAT in real-life setting. (Part B)(Up to 2 years)
Proportion of patients who change DAT components and reason to change of DAT. (Part B)(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)(Up to 2 years)
Proportion of patients using different type of antithrombotic therapy in long-term perspective (second year) after index event. (Part B)(Up to 2 years)
Proportion of patients who managed by cardiologist, therapist and other physician after discharge from the hospital. (Part B)(Up to 2 years)