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

Acute Coronary Syndrom Clinical Trial

— TOURACO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03362463
• Other study ID #: D1843R00256
• Status: Completed
• Start date: December 28, 2015
• Est. completion date: April 2, 2020

Study information

• Verified date: March 2021
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1191
• Est. completion date: April 2, 2020
• Est. primary completion date: April 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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:

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.

Related Conditions & MeSH terms

• Acute Coronary Syndrom
• Acute Coronary Syndrome

Intervention

Other:
• Non-Interventional Study
Non-Interventional Study

Locations

Country	Name	City	State
Qatar	Research Site	Doha

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Qatar, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	1 Month
Primary	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)	1 Month
Primary	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)	1 Month
Primary	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)	1 Month
Secondary	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)	6 Month
Secondary	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.	1,6,12,24 & 36 Month
Secondary	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	3 Years
Secondary	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)	6,12,24 & 36 Months
Secondary	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)	1 Year
Secondary	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)	24 Month
Secondary	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)	36 Month
Secondary	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)	6,12,24 & 36 Months
Secondary	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)	6,12,24 & 36 Months

External Links

•   redacted CSR synopsis