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

Completed

• Conditions: Acute Coronary Syndrome

• Registration Number: NCT02001545
• Lead Sponsor: AstraZeneca

Brief 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). 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-11-18
• Study First Submitted QC: 2013-11-28
• Study First Posted: 2013-12-05
• Study Start: 2014-02
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-13
• Last Update Posted: 2014-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 814

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Short-term antithrombotic management patterns (AMPs) in a real-life setting for patients hospitalized with an ACS	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 Outcome Measures

Name	Time	Method
Impact of the different AMPs on quality of life at the end of the first month after discharge from the hospital (using EuroQoL-5D).	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)
Impact of the different AMPs on quality of life at discharge from hospital (using EuroQoL-5D).	Baseline	Descriptive statistics will be calculated for this outcome measure using frequency tables (n, mean, median, standard deviation, minimum and maximum)
Variations in the acute clinical management strategies and AMPs.	Baseline	Descriptive statistics will be calculated for this outcome measure using frequency tables (n, frequency and percentage).
Determinants of AMP choices (i.e. patient's characteristics, hospital characteristics, coronary intervention strategies and type of coronary stents used)	Baseline	Descriptive statistics will be calculated for this outcome measure using frequency tables (n, frequency and percentage).

Trial Locations

Locations (1)

Research Site; 🇧🇬 Vratsa, Bulgaria