REal World Information on Cardiovascular Drug Management Patterns in Acute Coronary Syndrome paTients (RE-ACT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by AstraZeneca
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT02001545
First received: November 18, 2013
Last updated: August 25, 2014
Last verified: August 2014

November 18, 2013
August 25, 2014
February 2014
September 2014   (final data collection date for primary outcome measure)
Short-term antithrombotic management patterns (AMPs) in a real-life setting for patients hospitalized with an ACS [ Time Frame: Baseline ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT02001545 on ClinicalTrials.gov Archive Site
  • Variations in the acute clinical management strategies and AMPs. [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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). [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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). [ Time Frame: At the end of the first month after index event ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Descriptive statistics will be calculated for this outcome measure using frequency tables (n, frequency and percentage).
Same as current
Not Provided
Not Provided
 
REal World Information on Cardiovascular Drug Management Patterns in Acute Coronary Syndrome paTients
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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

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.

Acute Coronary Syndrome
Not Provided
Patients with STEMI and NSTEMI
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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
754
September 2014
September 2014   (final data collection date for primary outcome measure)

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).
Both
18 Years and older
No
Contact: Marina Staneva +359 (2) 44 55 000 ClinicalTrialTransparency@astrazeneca.com
Bulgaria
 
NCT02001545
NIS-CBG-XXX-2013/1
No
AstraZeneca
AstraZeneca
Not Provided
Principal Investigator: Elina Trendafilova, Ass. Prof. M.D National Cardiology Hospital, Sofia
Principal Investigator: Vasil Velchev, Ass. Prof. M.D. University Hospital St. Anna
AstraZeneca
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP