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CompletedNCT03362463TOURACOUpdated Apr 1, 2021

Long-Term Follow-Up and Management Patterns of Patients With Acute Coronary Syndrome in Middle East and Africa

An observational study in Acute Coronary Syndrom, sponsored by AstraZeneca. Completed at 1 site in Qatar. Per ClinicalTrials.gov, last updated 2021-04-01.

Sponsored by AstraZeneca · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,191
Sex
All
01

Study summary

A multinational, prospective and observational study that will assess the management of ACS in real-life practices in Middle East North Africa area.

Read the detailed description

The aim of this Middle Eastern and African study is to describe the short- and long-term (i.e. up to 3 years following the index event) management in patients hospitalized for an Acute Coronary Syndrome and pharmacological management patterns in a 'real-life' setting.

The TOURACO observational study will include not only hospitals with cardiac intervention facilities but also regional and community-type hospitals that have limited (if at all) cardiac intervention facilities. The treatments prescription will be left to the investigator discretion, and will be used in accordance with the local label of each country. Off-label medication is not authorized in TOURACO study.

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Conditions studied

  • Acute Coronary Syndrom
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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients presenting to the emergency room (or equivalent) and diagnosed with UA, STEMI or NSTEMI.

Inclusion criteria

Patients presenting to the emergency room (or equivalent) and diagnosed with UA, STEMI or NSTEMI will be eligible to participate if all the following criteria apply:

  1. Provision of subject informed consent.
  2. Contact Order Form has been provided.
  3. Female and/or male aged 18 years and over.
  4. Diagnosis of STEMI, NSTEMI or UA using the following definitions:

    Criteria for STEMI diagnosis :

    1. History of chest pain/discomfort, and
    2. Persistent ST-segment elevation (> 30 min) of ≥ 0.1 mV in 2 or more contiguous ECG leads or presumed new left bundle branch block (LBBB) on admission, and
    3. Elevation of cardiac biomarkers (CK-MB, troponins): at least one value above the 99th percentile of the upper reference limit.

    Criteria for NSTEMI diagnosis :

    (a) History of chest pain/discomfort, and (d) Lack of persistent ST-segment elevation, LBBB or intraventricular conduction disturbances, and (e) Elevation of cardiac biomarkers (CK-MB, troponins): at least one value above the 99th percentile of the upper reference limit.

    Criteria for Unstable Angina diagnosis :

    1. Symptoms of angina at rest or on minimal exercise, and
    2. (Transient) ST-T changes, and
    3. No significant increase in biomarkers of necrosis but objective evidence of ischemia by non-invasive imaging or significant coronary stenosis (at angiography).
  5. Hospitalized within 24 hours of onset of symptoms during the current episode* or transferred from another hospital within 24 hours of the onset of symptoms**.

    • In case of intermittent symptoms, the symptoms onset is that of the last episode ** If the referred hospital can get the initial data of the patient from the transferring hospital, transferring period is not considered as a limitation for patient initiation

Exclusion criteria

Exclusion Criteria:

Patients will not be eligible to participate if any of the following exclusion criteria are present:

  1. UA, STEMI and NSTEMI precipitated by or as a complication of surgery, trauma, or gastrointestinal bleeding or post-PCI.
  2. UA, STEMI and NSTEMI occurring in patients already hospitalized for other reasons.
  3. Presence of any condition/circumstance which in the opinion of the Investigator could significantly limit the complete follow-up of the patient (i.e. tourist, nonnative speaker or does not understand the local language, psychiatric disturbances).
  4. Already included in TOURACO observational study by another center/investigator.
  5. Presence of serious/severe co-morbidities in the opinion of the Investigator which may limit short-term (i.e. 6 months) life expectancy.
  6. If participating in any interventional clinical trial, should be adapted to each country local regulation.
  7. Patients with any psychotic disorders.
  8. Pregnancy.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,191 participants (actual)
Patient registry
No

Groups and cohorts

  • Acute Coronary Syndrom

    acute coronary syndrome in a real-life setting for patients hospitalized with an ACS (i.e. STEMI, NSTEMI, unstable angina)

    Other: Non-Interventional Study

Interventions

  • OtherNon-Interventional Study

    Non-Interventional Study

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What researchers measure

Primary outcomes

  1. Antithrombotic includinhg Dual Antiplatelet(DAPT) Treatment patterns

    Prescription of Antithrombotic including Dual Antiplatelet(DAPT) Treatment patterns at one month of follow-up after discharge from hospital, then confirm whether it is against international guidelines (ESC or ACC guidelines or against local guidelines when the international one are not applicable)

    Time frame: 1 Month

  2. Antihypertensive as apart of ACS Treatment patterns

    Prescription of Antihypertensive as apart of ACS Treatment patterns at one month of follow-up after discharge from hospital, then confirm whether it is against international guidelines (ESC or ACC guidelines or against local guidelines when the international one are not applicable)

    Time frame: 1 Month

  3. Diabetic lowering agents as a part of ACS Treatment patterns in the ACS patients with Diabetes including Type 2 DM

    Prescription of Diabetic lowering agents as a part of ACS Treatment patterns in the ACS patients with Diabetes including Type 2 DM at one month of follow-up after discharge from hospital, then confirm whether it is against international guidelines (ESC or ACC guidelines or against local guidelines when the international one are not applicable)

    Time frame: 1 Month

  4. Cholesterol lowering agents including statins as a part of ACS Treatment patterns

    Prescription of cholesterol lowering agents including statins as a part of ACS Treatment patterns at one month of follow-up after discharge from hospital, then confirm whether it is against international guidelines (ESC or ACC guidelines or against local guidelines when the international one are not applicable)

    Time frame: 1 Month

Secondary outcomes

  1. Antithrombotic includinhg Dual Antiplatelet(DAPT) Treatment patterns

    Prescription of Antithrombotic including Dual Antiplatelet(DAPT) Treatment patterns at one month of follow-up after discharge from hospital, then confirm whether it is against international guidelines (ESC or ACC guidelines or against local guidelines when the international one are not applicable)

    Time frame: 6 Month

  2. level of control of the different ACS related risk factor

    Level of control of ACS risk factors (diabetes, HT and dyslipidemia) at intrahospital period (from the first contact till discharge), and at 6 months of follow up. At 12, 24 and 36 months, the level will be measured if the patient comes for a planned visit.

    Time frame: 1,6,12,24 & 36 Month

  3. Deviation of the treatment patterns of ACS

    Deviation of the treatment patterns of ACS against what is recommended in the local guidelines for the management of ACS at the different time intervals

    Time frame: 3 Years

  4. Antihypertensive as apart of ACS Treatment patterns

    Prescription of Antihypertensive as apart of ACS Treatment patterns at one month of follow-up after discharge from hospital, then confirm whether it is against international guidelines (ESC or ACC guidelines or against local guidelines when the international one are not applicable)

    Time frame: 6,12,24 & 36 Months

  5. Antithrombotic includinhg Dual Antiplatelet(DAPT) Treatment patterns

    Prescription of Antithrombotic including Dual Antiplatelet(DAPT) Treatment patterns at one month of follow-up after discharge from hospital, then confirm whether it is against international guidelines (ESC or ACC guidelines or against local guidelines when the international one are not applicable)

    Time frame: 1 Year

  6. Antithrombotic includinhg Dual Antiplatelet(DAPT) Treatment patterns

    Prescription of Antithrombotic including Dual Antiplatelet(DAPT) Treatment patterns at one month of follow-up after discharge from hospital, then confirm whether it is against international guidelines (ESC or ACC guidelines or against local guidelines when the international one are not applicable)

    Time frame: 24 Month

  7. Antithrombotic includinhg Dual Antiplatelet(DAPT) Treatment patterns

    Prescription of Antithrombotic including Dual Antiplatelet(DAPT) Treatment patterns at one month of follow-up after discharge from hospital, then confirm whether it is against international guidelines (ESC or ACC guidelines or against local guidelines when the international one are not applicable)

    Time frame: 36 Month

  8. Diabetic lowering agents as a part of ACS Treatment patterns in the ACS patients with Diabetes including Type 2 DM

    Prescription of Diabetic lowering agents as a part of ACS Treatment patterns in the ACS patients with Diabetes including Type 2 DM at one month of follow-up after discharge from hospital, then confirm whether it is against international guidelines (ESC or ACC guidelines or against local guidelines when the international one are not applicable)

    Time frame: 6,12,24 & 36 Months

  9. Cholesterol lowering agents including statins as a part of ACS Treatment patterns

    Prescription of cholesterol lowering agents including statins as a part of ACS Treatment patterns at one month of follow-up after discharge from hospital, then confirm whether it is against international guidelines (ESC or ACC guidelines or against local guidelines when the international one are not applicable)

    Time frame: 6,12,24 & 36 Months

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Study locations

1 site
  • Research Site
    Doha, Qatar
07

References and documents

Individual participant data

Plan to share: Yes — Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

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Registry details

Key details

Study ID
NCT03362463
Lead sponsor
AstraZeneca
Responsible party
Sponsor
First posted
Dec 5, 2017
Start date
Dec 28, 2015
Primary completion
Apr 2, 2020
Completion
Apr 2, 2020
Last update
Apr 1, 2021
View the source record on ClinicalTrials.gov ↗

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