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

July 12, 2019 updated by: AstraZeneca

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

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5470

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • 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, Russian Federation
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Part A
PATIENTS RECEIVED THE STANDARD MEDICAL CARE AS DETERMINED BY THE TREATING CARDIOLOGIST
Part B
Patients on ticagrelor at the time of discharge from hospital

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Patients included in Federal ACS Registry from 1st Jan of 2012 till 1st March of 2015
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
During follow up
Up to 2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Patients included in Federal ACS Registry from 1st Jan of 2012 till 1st March of 2015
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
Patients included in Federal ACS Registry from 1st Jan of 2012 till 1st March of 2015
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 included in Federal ACS Registry from 1st Jan of 2012 till 1st March of 2015
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
Patients included in Federal ACS Registry from 1st Jan of 2012 till 1st March of 2015
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
Patients included in Federal ACS Registry from 1st Jan of 2012 till 1st March of 2015
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
During follow up
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
During follow-up period
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
During follow-up period
Up to 2 years
Proportion of patients who discontinued ticagrelor and reason to discontinue ticagrelor treatment. (Part B)
Time Frame: Up to 2 years
during follow-up period
Up to 2 years
Proportion of patients with significant violations of treatment regimen with ticagrelor. (Part B)
Time Frame: Up to 2 years
during follow-up period
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
during follow-up period
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
during follow-up period
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
during follow-up period
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
during follow-up period
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
during follow-up period
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
during follow-up period
Up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Vladimir Bulatov, MCMD, AstraZeneca
  • Principal Investigator: Eleva Oschepkova, MD, PROFESSOR OF CARDIOLOGY, Russian Cardiology Research and Production Complex

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 13, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 29, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 29, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 7, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 7, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 11, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 15, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 12, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D1843R00242

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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