Acute Coronary SyndromTOURACONCT03362463
Long-Term Follow-Up and Management Patterns of Patients With Acute Coronary Syndrome in Middle East and Africa
An observational study of Acute Coronary Syndrom, run by AstraZeneca at 1 site in Qatar.
Trial 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 more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Coronary Syndrom
- What is being tested?
- Non-Interventional Study
- How many people
- 1,191 participants
- Where
- 1 siteQatar
- Study dates
- 28 Dec 2015to 2 Apr 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients presenting to the emergency room (or equivalent) and diagnosed with UA, STEMI or NSTEMI.
Who may be able to join
- 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:
- Provision of subject informed consent.
- Contact Order Form has been provided.
- Female and/or male aged 18 years and over.
- Diagnosis of STEMI, NSTEMI or UA using the following definitions:
- Criteria for STEMI diagnosis :
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- History of chest pain/discomfort, and
- 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
- Elevation of cardiac biomarkers (CK-MB, troponins): at least one value above the 99th percentile of the upper reference limit.
- Criteria for NSTEMI diagnosis :
- 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 :
- Symptoms of angina at rest or on minimal exercise, and
- (Transient) ST-T changes, and
- No significant increase in biomarkers of necrosis but objective evidence of ischemia by non-invasive imaging or significant coronary stenosis (at angiography).
- 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
Who cannot join
- Patients will not be eligible to participate if any of the following exclusion criteria are present:
- UA, STEMI and NSTEMI precipitated by or as a complication of surgery, trauma, or gastrointestinal bleeding or post-PCI.
- UA, 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 (i.e. tourist, nonnative speaker or does not understand the local language, psychiatric disturbances).
- Already included in TOURACO observational study by another center/investigator.
- Presence of serious/severe co-morbidities in the opinion of the Investigator which may limit short-term (i.e. 6 months) life expectancy.
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- If participating in any interventional clinical trial, should be adapted to each country local regulation.
- Patients with any psychotic disorders.
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Acute Coronary Syndrom
- Being tested
- Non-Interventional Study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Interventional StudyOther
Non-Interventional Study
| Study group | Role | What they receive |
|---|---|---|
| Acute Coronary Syndrom | acute coronary syndrome in a real-life setting for patients hospitalized with an ACS (i.e. STEMI, NSTEMI, unstable angina) Receives: Other: Non-Interventional Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 1 Month
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)
Measured: 1 Month
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)
Measured: 1 Month
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)
Measured: 1 Month
Secondary outcomes (9)
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)
Measured: 6 Month
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.
Measured: 1,6,12,24 & 36 Month
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
Measured: 3 Years
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)
Measured: 6,12,24 & 36 Months
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)
Measured: 1 Year
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)
Measured: 24 Month
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)
Measured: 36 Month
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)
Measured: 6,12,24 & 36 Months
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)
Measured: 6,12,24 & 36 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2017
- Study start28 Dec 2015
- Primary completion2 Apr 2020
- Study completion2 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,191 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03362463
- Sponsor's protocol ID
- D1843R00256
- Acronym
- TOURACO
- Status last verified
- Mar 2021
- First submitted
- 6 Nov 2017
- Last updated
- 1 Apr 2021
- Results posted
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Follow-Up and Management Patterns of Patients With Acute Coronary Syndrome in Middle East and Africa
- ClinicalTrials.gov ID
- NCT03362463
- Acronym / sponsor ID
- TOURACO / D1843R00256
- Conditions
- Acute Coronary Syndrom
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,191 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 28 Dec 2015 (actual)
- Primary completion
- 2 Apr 2020 (actual)
- Study completion
- 2 Apr 2020 (actual)
- First posted
- 5 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A multinational, prospective and observational study that will assess the management of ACS in real-life practices in Middle East North Africa area.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute Coronary Syndrom | – | Other: Non-Interventional Studyacute coronary syndrome in a real-life setting for patients hospitalized with an ACS (i.e. STEMI, NSTEMI, unstable angina) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients presenting to the emergency room (or equivalent) and diagnosed with UA, STEMI or NSTEMI.
Key inclusion criteria (17 listed)
- 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:
- Provision of subject informed consent.
- Contact Order Form has been provided.
- Female and/or male aged 18 years and over.
- Diagnosis of STEMI, NSTEMI or UA using the following definitions:
Key exclusion criteria (9 listed)
- Patients will not be eligible to participate if any of the following exclusion criteria are present:
- UA, STEMI and NSTEMI precipitated by or as a complication of surgery, trauma, or gastrointestinal bleeding or post-PCI.
- UA, 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 (i.e. tourist, nonnative speaker or does not understand the local language, psychiatric disturbances).
- Already included in TOURACO observational study by another center/investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-Interventional StudyNon-Interventional Study | Other | Acute Coronary Syndrom |
Primary outcome
Antithrombotic includinhg Dual Antiplatelet(DAPT) Treatment patterns
Time frame: 1 Month
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)
Antihypertensive as apart of ACS Treatment patterns
Time frame: 1 Month
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)
Diabetic lowering agents as a part of ACS Treatment patterns in the ACS patients with Diabetes including Type 2 DM
Time frame: 1 Month
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)
Cholesterol lowering agents including statins as a part of ACS Treatment patterns
Time frame: 1 Month
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)
9 secondary outcomes
Antithrombotic includinhg Dual Antiplatelet(DAPT) Treatment patterns
Time frame: 6 Month
level of control of the different ACS related risk factor
Time frame: 1,6,12,24 & 36 Month
Deviation of the treatment patterns of ACS
Time frame: 3 Years
Antihypertensive as apart of ACS Treatment patterns
Time frame: 6,12,24 & 36 Months
Antithrombotic includinhg Dual Antiplatelet(DAPT) Treatment patterns
Time frame: 1 Year
Antithrombotic includinhg Dual Antiplatelet(DAPT) Treatment patterns
Time frame: 24 Month
Antithrombotic includinhg Dual Antiplatelet(DAPT) Treatment patterns
Time frame: 36 Month
Diabetic lowering agents as a part of ACS Treatment patterns in the ACS patients with Diabetes including Type 2 DM
Time frame: 6,12,24 & 36 Months
Cholesterol lowering agents including statins as a part of ACS Treatment patterns
Time frame: 6,12,24 & 36 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
- redacted CSR synopsisLink provided by the sponsor.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrom, run by AstraZeneca at 1 site in Qatar.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Qatar. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antithrombotic includinhg Dual Antiplatelet(DAPT) Treatment patterns (time frame: 1 Month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2021.