Clinical trial NCT02001545: REal World Information on Cardiovascular Drug Management Patterns in Acute Coronary Syndrome paTients
Official title: REal World Information on Cardiovascular Drug Management Patterns in Acute Coronary Syndrome paTients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Coronary Syndrome
Keywords: acute coronary syndrome, antithrombotic management patterns,quality of life, acute clinical management strategies
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2013-12-05
Enrollment: 814
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Short-term antithrombotic management patterns (AMPs) in a real-life setting for patients hospitalized with an ACS
timeFrame: Baseline
Secondary outcomes:
measure: Variations in the acute clinical management strategies and AMPs.
timeFrame: Baseline
measure: Impact of the different AMPs on quality of life at discharge from hospital (using EuroQoL-5D).
timeFrame: Baseline
measure: Impact of the different AMPs on quality of life at the end of the first month after discharge from the hospital (using EuroQoL-5D).
timeFrame: At the end of the first month after index event
measure: Determinants of AMP choices (i.e. patient's characteristics, hospital characteristics, coronary intervention strategies and type of coronary stents used)
timeFrame: Baseline
Other outcomes:
Locations:
city: Blagoevgrad
country: Bulgaria
facility: Research Site
city: Burgas
country: Bulgaria
facility: Research Site
city: Lovech
country: Bulgaria
facility: Research Site
city: Plovdiv
country: Bulgaria
facility: Research Site
city: Ruse
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Varna
country: Bulgaria
facility: Research Site
city: Vratsa
country: Bulgaria
facility: Research Site
Study officials:
affiliation: National Cardiology Hospital, Sofia
name: Elina Trendafilova, Ass. Prof. M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital St. Anna
name: Vasil Velchev, Ass. Prof. M.D.
role: PRINCIPAL_INVESTIGATOR
References: