Clinical trial NCT02288260: RuSsian RegisTry of Acute CoronaRy SyndromE TreAtMent and Approach in Dual Antiplatelet Therapy
Official title: RuSsian RegisTry of Acute CoronaRy SyndromE TreAtMent and Approach in Dual Antiplatelet Therapy (STREAM)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Coronary Syndrome
Keywords: Acute Coronary Syndrome
Russian ACS Registry
ticagrelor
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2014-11-11
Enrollment: 5470
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.


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

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)
timeFrame: 1st Jan of 2012-1st March of 2015
measure: Proportion of patients taking ticagrelor with cardiovascular (CV) events after discharge from hospital depending on DAT (Dual Antiplatelet Therapy) duration. (Part B)
timeFrame: 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)
timeFrame: 1st Jan of 2012-1st March of 2015
measure: Time from first symptoms onset to the time of hospitalization (Part A)
timeFrame: 1st Jan of 2012-1st March of 2015
measure: Proportion of patients receiving different types of ACS treatment depending on ACS symptoms duration prior hospitalization. (Part A)
timeFrame: 1st Jan of 2012-1st March of 2015
measure: Patients demographic and baseline characteristics (age, gender, weight, height). (Part A)
timeFrame: 1st Jan of 2012-1st March of 2015
measure: Proportion of patients with different type of coronary intervention strategies. (Part A)
timeFrame: 1st Jan of 2012-1st March of 2015
measure: Proportion of patients who is on ticagrelor treatment during 0-3 months, >3-6 months, >6-9 months, >9-12 months. (Part B)
timeFrame: Up to 2 years
measure: 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)
timeFrame: Up to 2 years
measure: Proportion of patients with thrombo-embolic events during follow-up depending on DAT therapy duration. (Part B)
timeFrame: Up to 2 years
measure: Proportion of patients who discontinued ticagrelor and reason to discontinue ticagrelor treatment. (Part B)
timeFrame: Up to 2 years
measure: Proportion of patients with significant violations of treatment regimen with ticagrelor. (Part B)
timeFrame: Up to 2 years
measure: 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)
timeFrame: Up to 2 years
measure: Proportion of patients who discontinued DAT and the reason of discontinuation of DAT in real-life setting. (Part B)
timeFrame: Up to 2 years
measure: Proportion of patients who change DAT components and reason to change of DAT. (Part B)
timeFrame: Up to 2 years
measure: 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)
timeFrame: Up to 2 years
measure: Proportion of patients using different type of antithrombotic therapy in long-term perspective (second year) after index event. (Part B)
timeFrame: Up to 2 years
measure: Proportion of patients who managed by cardiologist, therapist and other physician after discharge from the hospital. (Part B)
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Arkhangelsk
country: Russian Federation
facility: Research Site
city: Cheboksary
country: Russian Federation
facility: Research Site
city: Irkutsk
country: Russian Federation
facility: Research Site
city: Kazan
country: Russian Federation
facility: Research Site
city: Kemerovo
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Novosibirsk
country: Russian Federation
facility: Research Site
city: Petrozavodsk
country: Russian Federation
facility: Research Site
city: Ryazan
country: Russian Federation
facility: Research Site
city: Saint-Petersburg
country: Russian Federation
facility: Research Site
city: Stavropol
country: Russian Federation
facility: Research Site
city: Tomsk
country: Russian Federation
facility: Research Site
city: Tyumen
country: Russian Federation
facility: Research Site
city: Ufa
country: Russian Federation
facility: Research Site
city: Vladivostok
country: Russian Federation
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Vladimir Bulatov, MCMD
role: STUDY_DIRECTOR
affiliation: Russian Cardiology Research and Production Complex
name: Eleva Oschepkova, MD, PROFESSOR OF CARDIOLOGY
role: PRINCIPAL_INVESTIGATOR
References: