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

AstraZeneca5,470 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

5,470

Conditions

Acute Coronary Syndrome

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (15)

Research Site

Arkhangelsk, Russia

Research Site

Cheboksary, Russia

Research Site

Irkutsk, Russia

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)

Patients included in Federal ACS Registry from 1st Jan of 2012 till 1st March of 2015

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)

During follow up

Time frame: Up to 2 years

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)

Patients included in Federal ACS Registry from 1st Jan of 2012 till 1st March of 2015

Time frame: 1st Jan of 2012-1st March of 2015

Time from first symptoms onset to the time of hospitalization (Part A)

Patients included in Federal ACS Registry from 1st Jan of 2012 till 1st March of 2015

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)

Patients included in Federal ACS Registry from 1st Jan of 2012 till 1st March of 2015

Time frame: 1st Jan of 2012-1st March of 2015

Patients demographic and baseline characteristics (age, gender, weight, height). (Part A)

Patients included in Federal ACS Registry from 1st Jan of 2012 till 1st March of 2015

Data from ClinicalTrials.gov

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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

...and 5 more locations

Time frame: 1st Jan of 2012-1st March of 2015

Proportion of patients with different type of coronary intervention strategies. (Part A)

Patients included in Federal ACS Registry from 1st Jan of 2012 till 1st March of 2015

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)

During follow up

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)

During follow-up period

Time frame: Up to 2 years

Proportion of patients with thrombo-embolic events during follow-up depending on DAT therapy duration. (Part B)

During follow-up period

Time frame: Up to 2 years

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

during follow-up period

Time frame: Up to 2 years

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

during follow-up period

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)

during follow-up period

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)

during follow-up period

Time frame: Up to 2 years

Proportion of patients who change DAT components and reason to change of DAT. (Part B)

during follow-up period

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)

during follow-up period

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)

during follow-up period

Time frame: Up to 2 years

Proportion of patients who managed by cardiologist, therapist and other physician after discharge from the hospital. (Part B)

during follow-up period

Time frame: Up to 2 years