REal World Information on Cardiovascular Drug Management Patterns in Acute Coronary Syndrome paTients (RE-ACT)

November 13, 2014 updated by: AstraZeneca
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 Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

814

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

  • Bulgaria
      • Blagoevgrad, Bulgaria
        • Research Site
      • Burgas, Bulgaria
        • Research Site
      • Lovech, Bulgaria
        • Research Site
      • Plovdiv, Bulgaria
        • Research Site
      • Ruse, Bulgaria
        • Research Site
      • Sofia, Bulgaria
        • Research Site
      • Varna, Bulgaria
        • Research Site
      • Vratsa, Bulgaria
        • 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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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).

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
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Variations in the acute clinical management strategies and AMPs.
Time Frame: Baseline
Descriptive statistics will be calculated for this outcome measure using frequency tables (n, frequency and percentage).
Baseline
Impact of the different AMPs on quality of life at discharge from hospital (using EuroQoL-5D).
Time Frame: Baseline
Descriptive statistics will be calculated for this outcome measure using frequency tables (n, mean, median, standard deviation, minimum and maximum)
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
Descriptive statistics will be calculated for this outcome measure using frequency tables (n, mean, median, standard deviation, minimum and maximum)
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
Descriptive statistics will be calculated for this outcome measure using frequency tables (n, frequency and percentage).
Baseline

Collaborators and Investigators

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

Sponsor

AstraZeneca

Investigators

  • Principal Investigator: Elina Trendafilova, Ass. Prof. M.D, National Cardiology Hospital, Sofia
  • Principal Investigator: Vasil Velchev, Ass. Prof. M.D., University Hospital St. Anna

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

February 1, 2014

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

November 18, 2013

First Submitted That Met QC Criteria

November 28, 2013

First Posted (Estimate)

December 5, 2013

Study Record Updates

Last Update Posted (Estimate)

November 14, 2014

Last Update Submitted That Met QC Criteria

November 13, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIS-CBG-XXX-2013/1

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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