Acute Coronary SyndromeSTREAMNCT02288260
RuSsian RegisTry of Acute CoronaRy SyndromE TreAtMent and Approach in Dual Antiplatelet Therapy
An observational study of Acute Coronary Syndrome, run by AstraZeneca at 15 sites in Russia.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Coronary Syndrome
- How many people
- 5,470 participants
- Where
- 15 sitesRussia
- Study dates
- 13 Apr 2015to 29 Jul 2018
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Russia15 sites
Research Site
Arkhangelsk
Research Site
Cheboksary
Research Site
Irkutsk
Research Site
Kazan'
Research Site
Kemerovo
Research Site
Moscow
Research Site
Novosibirsk
Research Site
Petrozavodsk
Research Site
Ryazan
Research Site
Saint Petersburg
Research Site
Stavropol
Research Site
Tomsk
Research Site
Tyumen
Research Site
Ufa
Research Site
Vladivostok
About this study
Official title: 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.
- Conditions
- Acute Coronary Syndrome
- Keywords
- Acute Coronary Syndrome, Russian ACS Registry, ticagrelor
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Up to 2 years
Secondary outcomes (16)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Up to 2 years
Proportion of patients who discontinued ticagrelor and reason to discontinue ticagrelor treatment. (Part B)
during follow-up period
Measured: Up to 2 years
Proportion of patients with significant violations of treatment regimen with ticagrelor. (Part B)
during follow-up period
Measured: 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
Measured: 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
Measured: Up to 2 years
Proportion of patients who change DAT components and reason to change of DAT. (Part B)
during follow-up period
Measured: 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
Measured: 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
Measured: 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
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2014 (estimated)
- Study start13 Apr 2015
- Primary completion29 Jul 2018
- Study completion29 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 5,470 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vladimir Bulatov, MCMD, Study director, AstraZenecaEleva Oschepkova, MD, PROFESSOR OF CARDIOLOGY, Principal investigator, Russian Cardiology Research and Production Complex
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02288260
- Sponsor's protocol ID
- D1843R00242
- Acronym
- STREAM
- Status last verified
- Jul 2019
- First submitted
- 7 Nov 2014
- Last updated
- 15 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RuSsian RegisTry of Acute CoronaRy SyndromE TreAtMent and Approach in Dual Antiplatelet Therapy (STREAM)
- ClinicalTrials.gov ID
- NCT02288260
- Acronym / sponsor ID
- STREAM / D1843R00242
- Conditions
- Acute Coronary Syndrome
- Keywords
- Acute Coronary Syndrome, Russian ACS Registry, ticagrelor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,470 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 13 Apr 2015 (actual)
- Primary completion
- 29 Jul 2018 (actual)
- Study completion
- 29 Jul 2018 (actual)
- First posted
- 11 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
16 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)
Time frame: 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
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 demographic and baseline characteristics (age, gender, weight, height). (Part A)
Time frame: 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
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
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
Proportion of patients with thrombo-embolic events during follow-up depending on DAT therapy duration. (Part B)
Time frame: Up to 2 years
Proportion of patients who discontinued ticagrelor and reason to discontinue ticagrelor treatment. (Part B)
Time frame: Up to 2 years
Proportion of patients with significant violations of treatment regimen with ticagrelor. (Part B)
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)
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)
Time frame: 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
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
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
Proportion of patients who managed by cardiologist, therapist and other physician after discharge from the hospital. (Part B)
Time frame: Up to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2019.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vladimir Bulatov, MCMD study director
AstraZeneca
Eleva Oschepkova, MD, PROFESSOR OF CARDIOLOGY principal investigator
Russian Cardiology Research and Production Complex
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome, run by AstraZeneca at 15 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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) (time frame: 1st Jan of 2012-1st March of 2015). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2019; AzTrials last refreshed its copy on 8 Nov 2026.