Acute Coronary SyndromeRE-ACTNCT02001545
REal World Information on Cardiovascular Drug Management Patterns in Acute Coronary Syndrome paTients
An observational study of Acute Coronary Syndrome, run by AstraZeneca at 8 sites in Bulgaria.
Trial summary
RE-ACT is a national, multi-centre, observational, prospective, longitudinal cohort study which will include patients hospitalized for ACS within 24 hours of symptom onset and who have a final diagnosis of ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- How many people
- 814 participants
- Where
- 8 sitesBulgaria
- Study dates
- Feb 2014to Sep 2014
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged 18 years or older, hospitalized and diagnosed with STEMI (ST-segment elevation myocardial infarction) or NSTEMI (non-ST-segment elevation myocardial infarction) within 24 hours of symptom onset.
Who may be able to join
- Provision of subject informed consent
- Patients hospitalized and diagnosed with STEMI or NSTEMI
- Hospitalized within 24 hours of onset of symptoms or transferred from another hospital within 24 hours of the onset of symptoms
Who cannot join
- STEMI and NSTEMI precipitated by or as a complication of surgery, trauma, or GI bleeding or post-PCI.
- STEMI and NSTEMI occurring in patients already hospitalized for other reasons.
- Presence of any condition/circumstance which in the opinion of the investigator could significantly limit the complete follow up of the patient (e.g. tourist, non-native speaker or does not understand the local language, psychiatric disturbances).
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Bulgaria8 sites
Research Site
Blagoevgrad
Research Site
Burgas
Research Site
Lovech
Research Site
Plovdiv
Research Site
Rousse
Research Site
Sofia
Research Site
Varna
Research Site
Vratsa
About this study
RE-ACT is a national, multi-centre, observational, prospective, longitudinal cohort study which will include patients hospitalized for ACS within 24 hours of symptom onset and who have a final diagnosis of ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI). This study aims to describe the short-term (at the end of the first month after index event) antithrombotic management patterns in a "real-life" setting for patients hospitalized with an acute coronary syndrome.
- Conditions
- Acute Coronary Syndrome
- Keywords
- acute coronary syndrome, antithrombotic management patterns,quality of life, acute clinical management strategies
- 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 |
|---|---|---|
| Patients with STEMI and NSTEMI | Patients aged 18 years or older, hospitalized and diagnosed with STEMI (ST-segment elevation myocardial infarction) or NSTEMI (non-ST-segment elevation myocardial infarction) within 24 hours of symptom onset. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short-term antithrombotic management patterns (AMPs) in a real-life setting for patients hospitalized with an ACS
Descriptive statistics will be calculated for this outcome measure using frequency tables (n, frequency and percentage). Antithrombotic management patterns will be grouped taking into account only the different treatment options shown by the descriptive analysis.
Measured: Baseline
Secondary outcomes (4)
Variations in the acute clinical management strategies and AMPs.
Descriptive statistics will be calculated for this outcome measure using frequency tables (n, frequency and percentage).
Measured: Baseline
Impact of the different AMPs on quality of life at discharge from hospital (using EuroQoL-5D).
Descriptive statistics will be calculated for this outcome measure using frequency tables (n, mean, median, standard deviation, minimum and maximum)
Measured: Baseline
Impact of the different AMPs on quality of life at the end of the first month after discharge from the hospital (using EuroQoL-5D).
Descriptive statistics will be calculated for this outcome measure using frequency tables (n, mean, median, standard deviation, minimum and maximum)
Measured: At the end of the first month after index event
Determinants of AMP choices (i.e. patient's characteristics, hospital characteristics, coronary intervention strategies and type of coronary stents used)
Descriptive statistics will be calculated for this outcome measure using frequency tables (n, frequency and percentage).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2013 (estimated)
- Study startFeb 2014
- Primary completionSep 2014
- Study completionSep 2014
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
- Prospective
- Enrolment
- 814 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Elina Trendafilova, Ass. Prof. M.D, Principal investigator, National Cardiology Hospital, SofiaVasil Velchev, Ass. Prof. M.D., Principal investigator, University Hospital St. Anna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02001545
- Sponsor's protocol ID
- NIS-CBG-XXX-2013/1
- Acronym
- RE-ACT
- Status last verified
- Nov 2014
- First submitted
- 18 Nov 2013
- Last updated
- 14 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REal World Information on Cardiovascular Drug Management Patterns in Acute Coronary Syndrome paTients
- ClinicalTrials.gov ID
- NCT02001545
- Acronym / sponsor ID
- RE-ACT / NIS-CBG-XXX-2013/1
- Conditions
- Acute Coronary Syndrome
- Keywords
- acute coronary syndrome, antithrombotic management patterns,quality of life, acute clinical management strategies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 814 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Feb 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 5 Dec 2013 (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.
RE-ACT is a national, multi-centre, observational, prospective, longitudinal cohort study which will include patients hospitalized for ACS within 24 hours of symptom onset and who have a final diagnosis of ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI). This study aims to describe the short-term (at the end of the first month after index event) antithrombotic management patterns in a "real-life" setting for patients hospitalized with an acute coronary syndrome.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with STEMI and NSTEMI | – | –Patients aged 18 years or older, hospitalized and diagnosed with STEMI (ST-segment elevation myocardial infarction) or NSTEMI (non-ST-segment elevation myocardial infarction) within 24 hours of symptom onset. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18 years or older, hospitalized and diagnosed with STEMI (ST-segment elevation myocardial infarction) or NSTEMI (non-ST-segment elevation myocardial infarction) within 24 hours of symptom onset.
Key inclusion criteria (3 listed)
- Provision of subject informed consent
- Patients hospitalized and diagnosed with STEMI or NSTEMI
- Hospitalized within 24 hours of onset of symptoms or transferred from another hospital within 24 hours of the onset of symptoms
Key exclusion criteria (3 listed)
- STEMI and NSTEMI precipitated by or as a complication of surgery, trauma, or GI bleeding or post-PCI.
- STEMI and NSTEMI occurring in patients already hospitalized for other reasons.
- Presence of any condition/circumstance which in the opinion of the investigator could significantly limit the complete follow up of the patient (e.g. tourist, non-native speaker or does not understand the local language, psychiatric disturbances).
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
Short-term antithrombotic management patterns (AMPs) in a real-life setting for patients hospitalized with an ACS
Time frame: Baseline
Descriptive statistics will be calculated for this outcome measure using frequency tables (n, frequency and percentage). Antithrombotic management patterns will be grouped taking into account only the different treatment options shown by the descriptive analysis.
4 secondary outcomes
Variations in the acute clinical management strategies and AMPs.
Time frame: Baseline
Impact of the different AMPs on quality of life at discharge from hospital (using EuroQoL-5D).
Time frame: Baseline
Impact of the different AMPs on quality of life at the end of the first month after discharge from the hospital (using EuroQoL-5D).
Time frame: At the end of the first month after index event
Determinants of AMP choices (i.e. patient's characteristics, hospital characteristics, coronary intervention strategies and type of coronary stents used)
Time frame: Baseline
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 14 Nov 2014.
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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.
Elina Trendafilova, Ass. Prof. M.D principal investigator
National Cardiology Hospital, Sofia
Vasil Velchev, Ass. Prof. M.D. principal investigator
University Hospital St. Anna
8 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 8 sites in Bulgaria.
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 3 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 14 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Bulgaria. 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?
Short-term antithrombotic management patterns (AMPs) in a real-life setting for patients hospitalized with an ACS (time frame: Baseline). 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 14 Nov 2014.