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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02001545

Acronym

RE-ACT

Enrollment

814

Registered

2013-12-05

Start date

2014-02-28

Completion date

2014-09-30

Last updated

2014-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Coronary Syndrome

Keywords

acute coronary syndrome, antithrombotic management patterns,quality of life, acute clinical management strategies

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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).

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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).
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)
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)
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).

Countries

Bulgaria

Outcome results