NCT02001545

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
814

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2014

Shorter than P25 for all trials

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 18, 2013

Completed
17 days until next milestone

First Posted

Study publicly available on registry

December 5, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

November 14, 2014

Status Verified

November 1, 2014

Enrollment Period

7 months

First QC Date

November 18, 2013

Last Update Submit

November 13, 2014

Conditions

Acute Coronary Syndrome

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

  • Variations in the acute clinical management strategies and AMPs.

    Baseline

  • Impact of the different AMPs on quality of life at discharge from hospital (using EuroQoL-5D).

    Baseline

  • 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

  • Determinants of AMP choices (i.e. patient's characteristics, hospital characteristics, coronary intervention strategies and type of coronary stents used)

    Baseline

Study Arms (1)

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 Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Research Site

Blagoevgrad, Bulgaria

Location

Research Site

Burgas, Bulgaria

Location

Research Site

Lovech, Bulgaria

Location

Research Site

Plovdiv, Bulgaria

Location

Research Site

Rousse, Bulgaria

Location

Research Site

Sofia, Bulgaria

Location

Research Site

Varna, Bulgaria

Location

Research Site

Vratsa, Bulgaria

Location

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Elina Trendafilova, Ass. Prof. M.D

    National Cardiology Hospital, Sofia

    PRINCIPAL INVESTIGATOR

  • Vasil Velchev, Ass. Prof. M.D.

    University Hospital St. Anna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2013

First Posted

December 5, 2013

Study Start

February 1, 2014

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

November 14, 2014

Record last verified: 2014-11

Locations

BU(8)