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

Acute Coronary Syndrome Clinical Trial

— RE-ACT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02001545
• Other study ID #: NIS-CBG-XXX-2013/1
• Status: Completed
• Phase: N/A
• First received: November 18, 2013
• Last updated: November 13, 2014
• Start date: February 2014
• Est. completion date: September 2014

Study information

• Verified date: November 2014
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Bulgaria: Bulgarian Drug Agency
• Study type: Observational

Clinical 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). 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 814
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Locations

Country	Name	City	State
Bulgaria	Research Site	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

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Bulgaria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline	No
Secondary	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).	Baseline	No
Secondary	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)	Baseline	No
Secondary	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)	At the end of the first month after index event	No
Secondary	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).	Baseline	No