Overview

This trial is active, not recruiting.

Condition acute coronary syndrome
Sponsor AstraZeneca
Start date April 2015
End date June 2018
Trial size 6000 participants
Trial identifier NCT02288260, D1843R00242

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective cross-sectional
Arm
PATIENTS RECEIVED THE STANDARD MEDICAL CARE AS DETERMINED BY THE TREATING CARDIOLOGIST
Patients on ticagrelor at the time of discharge from hospital

Primary Outcomes

Measure
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
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

Secondary Outcomes

Measure
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
Time from first symptoms onset to the time of hospitalization (Part A)
time frame: 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)
time frame: 1st Jan of 2012-1st March of 2015
Patients demographic and baseline characteristics (age, gender, weight, height). (Part A)
time frame: 1st Jan of 2012-1st March of 2015
Proportion of patients with different type of coronary intervention strategies. (Part A)
time frame: 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)
time frame: 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)
time frame: Up to 2 years
Proportion of patients with thrombo-embolic events during follow-up depending on DAT therapy duration. (Part B)
time frame: Up to 2 years
Proportion of patients who discontinued ticagrelor and reason to discontinue ticagrelor treatment. (Part B)
time frame: Up to 2 years
Proportion of patients with significant violations of treatment regimen with ticagrelor. (Part B)
time frame: 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)
time frame: Up to 2 years
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
Proportion of patients who change DAT components and reason to change of DAT. (Part B)
time frame: 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)
time frame: Up to 2 years
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
Proportion of patients who managed by cardiologist, therapist and other physician after discharge from the hospital. (Part B)
time frame: Up to 2 years

Eligibility Criteria

Male or female participants of any age.

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

Additional Information

Official title RuSsian RegisTry of Acute CoronaRy SyndromE TreAtMent and Approach in Dual Antiplatelet Therapy (STREAM)
Principal investigator Eleva Oschepkova, MD, PROFESSOR OF CARDIOLOGY
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by AstraZeneca.