Acute Coronary Syndrome
Conditions
Keywords
Acute Coronary Syndrome, Russian ACS Registry, ticagrelor
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.
Interventions
None listed
Sponsors
AstraZeneca
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Proportion of patients who discontinued ticagrelor and reason to discontinue ticagrelor treatment. (Part B) | Up to 2 years | during follow-up period |
| 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 |
| 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 |
| 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 |
| Proportion of patients who change DAT components and reason to change of DAT. (Part B) | Up to 2 years | during follow-up period |
| 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 |
| 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 |
| 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 |
| Proportion of patients with significant violations of treatment regimen with ticagrelor. (Part B) | Up to 2 years | during follow-up period |
| 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 |
Countries
Russia
Outcome results
None listed