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Completed

NCT Number: NCT02001545

REal World Information on Cardiovascular Drug Management Patterns in Acute Coronary Syndrome paTients

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.

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Key information

Conditions

Acute Coronary Syndrome Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Blagoevgrad, Bulgaria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

  2. 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)

  3. 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)

  4. 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).

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Acronym: RE-ACT

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Dec 5, 2013
Registry last updated
Nov 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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