ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03362463
Recruitment Status : Active, not recruiting
First Posted : December 5, 2017
Last Update Posted : September 12, 2018
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

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.

Condition or disease Intervention/treatment
Acute Coronary Syndrom Other: Non-Interventional Study

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 Type : Observational
Estimated Enrollment : 1191 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Long-Term Follow-Up and Management Patterns of Patients With Acute Coronary Syndrome in Middle East and Africa
Actual Study Start Date : December 28, 2015
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Group/Cohort Intervention/treatment
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
Non-Interventional Study




Primary Outcome Measures :
  1. 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)

  2. 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)

  3. 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)

  4. 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)


Secondary Outcome Measures :
  1. Antithrombotic includinhg Dual Antiplatelet(DAPT) Treatment patterns [ Time Frame: 6 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)

  2. level of control of the different ACS related risk factor [ Time Frame: 1,6,12,24 & 36 Month ]
    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.

  3. Deviation of the treatment patterns of ACS [ Time Frame: 3 Years ]
    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

  4. Antihypertensive as apart of ACS Treatment patterns [ Time Frame: 6,12,24 & 36 Months ]
    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)

  5. Antithrombotic includinhg Dual Antiplatelet(DAPT) Treatment patterns [ Time Frame: 1 Year ]
    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. Antithrombotic includinhg Dual Antiplatelet(DAPT) Treatment patterns [ Time Frame: 24 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)

  7. Antithrombotic includinhg Dual Antiplatelet(DAPT) Treatment patterns [ Time Frame: 36 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)

  8. 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 ]
    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)

  9. Cholesterol lowering agents including statins as a part of ACS Treatment patterns [ Time Frame: 6,12,24 & 36 Months ]
    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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03362463


Locations
Algeria
Research Site
Algiers, Algeria
Research Site
Annaba, Algeria
Research Site
Constantine, Algeria
Research Site
Oran, Algeria
Bahrain
Research Site
Manama, Bahrain
Egypt
Research Site
Alexandria, Egypt
Research Site
Aswan, Egypt
Research Site
Cairo, Egypt
Research Site
Mansoura, Egypt
Research Site
Sohag, Egypt
Research Site
Tanta, Egypt
Kuwait
Research Site
Kuwait City, Kuwait
Oman
Research Site
Musqat, Oman
Qatar
Research Site
Doha, Qatar
Saudi Arabia
Research Site
Dammam, Saudi Arabia
Research Site
Jeddah, Saudi Arabia
Research Site
Riyadh, Saudi Arabia
United Arab Emirates
Research Site
Abu Dhabi, United Arab Emirates
Research Site
Al Ain, United Arab Emirates
Research Site
Dubai, United Arab Emirates
Sponsors and Collaborators
AstraZeneca

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT03362463     History of Changes
Other Study ID Numbers: D1843R00256
First Posted: December 5, 2017    Key Record Dates
Last Update Posted: September 12, 2018
Last Verified: September 2018

Additional relevant MeSH terms:
Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases