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

Acute Coronary Syndrome Clinical Trial

— STREAM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02288260
• Other study ID #: D1843R00242
• Status: Completed
• Start date: April 13, 2015
• Est. completion date: July 29, 2018

Study information

• Verified date: July 2019
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5470
• Est. completion date: July 29, 2018
• Est. primary completion date: July 29, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Locations

Country	Name	City	State
Russian Federation	Research Site	Arkhangelsk
Russian Federation	Research Site	Cheboksary
Russian Federation	Research Site	Irkutsk
Russian Federation	Research Site	Kazan
Russian Federation	Research Site	Kemerovo
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Novosibirsk
Russian Federation	Research Site	Petrozavodsk
Russian Federation	Research Site	Ryazan
Russian Federation	Research Site	Saint-Petersburg
Russian Federation	Research Site	Stavropol
Russian Federation	Research Site	Tomsk
Russian Federation	Research Site	Tyumen
Russian Federation	Research Site	Ufa
Russian Federation	Research Site	Vladivostok

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1st Jan of 2012-1st March of 2015
Primary	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	Up to 2 years
Secondary	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	1st Jan of 2012-1st March of 2015
Secondary	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	1st Jan of 2012-1st March of 2015
Secondary	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	1st Jan of 2012-1st March of 2015
Secondary	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	1st Jan of 2012-1st March of 2015
Secondary	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	1st Jan of 2012-1st March of 2015
Secondary	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	Up to 2 years
Secondary	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	Up to 2 years
Secondary	Proportion of patients with thrombo-embolic events during follow-up depending on DAT therapy duration. (Part B)	During follow-up period	Up to 2 years
Secondary	Proportion of patients who discontinued ticagrelor and reason to discontinue ticagrelor treatment. (Part B)	during follow-up period	Up to 2 years
Secondary	Proportion of patients with significant violations of treatment regimen with ticagrelor. (Part B)	during follow-up period	Up to 2 years
Secondary	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	Up to 2 years
Secondary	Proportion of patients who discontinued DAT and the reason of discontinuation of DAT in real-life setting. (Part B)	during follow-up period	Up to 2 years
Secondary	Proportion of patients who change DAT components and reason to change of DAT. (Part B)	during follow-up period	Up to 2 years
Secondary	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	Up to 2 years
Secondary	Proportion of patients using different type of antithrombotic therapy in long-term perspective (second year) after index event. (Part B)	during follow-up period	Up to 2 years
Secondary	Proportion of patients who managed by cardiologist, therapist and other physician after discharge from the hospital. (Part B)	during follow-up period	Up to 2 years

External Links

•   Link