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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT02001545
First received: November 18, 2013
Last updated: November 13, 2014
Last verified: November 2014
  Purpose

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.


Condition
Acute Coronary Syndrome

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: REal World Information on Cardiovascular Drug Management Patterns in Acute Coronary Syndrome paTients

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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).


Enrollment: 814
Study Start Date: February 2014
Study Completion Date: September 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02001545

Locations
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, Bulgaria
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Elina Trendafilova, Ass. Prof. M.D National Cardiology Hospital, Sofia
Principal Investigator: Vasil Velchev, Ass. Prof. M.D. University Hospital St. Anna
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02001545     History of Changes
Other Study ID Numbers: NIS-CBG-XXX-2013/1
Study First Received: November 18, 2013
Last Updated: November 13, 2014
Health Authority: Bulgaria: Bulgarian Drug Agency

Keywords provided by AstraZeneca:
acute coronary syndrome, antithrombotic management patterns,quality of life, acute clinical management strategies

Additional relevant MeSH terms:
Acute Coronary Syndrome
Syndrome
Angina Pectoris
Cardiovascular Diseases
Chest Pain
Disease
Heart Diseases
Myocardial Ischemia
Pain
Pathologic Processes
Signs and Symptoms
Vascular Diseases
Cardiovascular Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014