Clinical trial NCT03362463: Long-Term Follow-Up and Management Patterns of Patients With Acute Coronary Syndrome in Middle East and Africa
Official title: Long-Term Follow-Up and Management Patterns of Patients With Acute Coronary Syndrome in Middle East and Africa
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Coronary Syndrom
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2017-12-05
Enrollment: 1191
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting to the emergency room (or equivalent) and diagnosed with UA, STEMI or NSTEMI.

Brief summary: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Antithrombotic includinhg Dual Antiplatelet(DAPT) Treatment patterns
timeFrame: 1 Month
measure: Antihypertensive as apart of ACS Treatment patterns
timeFrame: 1 Month
measure: Diabetic lowering agents as a part of ACS Treatment patterns in the ACS patients with Diabetes including Type 2 DM
timeFrame: 1 Month
measure: Cholesterol lowering agents including statins as a part of ACS Treatment patterns
timeFrame: 1 Month
Secondary outcomes:
measure: Antithrombotic includinhg Dual Antiplatelet(DAPT) Treatment patterns
timeFrame: 6 Month
measure: level of control of the different ACS related risk factor
timeFrame: 1,6,12,24 & 36 Month
measure: Deviation of the treatment patterns of ACS
timeFrame: 3 Years
measure: Antihypertensive as apart of ACS Treatment patterns
timeFrame: 6,12,24 & 36 Months
measure: Antithrombotic includinhg Dual Antiplatelet(DAPT) Treatment patterns
timeFrame: 1 Year
measure: Antithrombotic includinhg Dual Antiplatelet(DAPT) Treatment patterns
timeFrame: 24 Month
measure: Antithrombotic includinhg Dual Antiplatelet(DAPT) Treatment patterns
timeFrame: 36 Month
measure: Diabetic lowering agents as a part of ACS Treatment patterns in the ACS patients with Diabetes including Type 2 DM
timeFrame: 6,12,24 & 36 Months
measure: Cholesterol lowering agents including statins as a part of ACS Treatment patterns
timeFrame: 6,12,24 & 36 Months
Other outcomes:
Locations:
city: Doha
country: Qatar
facility: Research Site
Study officials:
References: