Potential Drug Interactions With Bisoprolol in Egyptian Patients With ACS

Study Overview
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Brief Summary
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Acute coronary syndrome (ACS) is any group of clinical symptoms compatible with acute myocardial ischemia and includes unstable angina (UA), non-ST-segment elevation myocardial infarction (NSTEMI), and ST-segment elevation myocardial infarction (STEMI). (1). In Egypt, the overall prevalence of coronary heart disease (CHD) is 8.3 % (2). In addition, CHD in Egypt is the principal cause of death, responsible for 21.73% of total mortality (2). Beta-blockers have shown to reduce the short-term risk of a reinfarction and the long-term risk of all-cause mortality and cardiovascular mortality (3). Beta blockers are used within 24 hours of ACS and given as long-term therapy after discharge (4). The Most frequently used drug in Egypt is bisoprolol. In patients with myocardial infarction undergoing primary percutaneous coronary intervention, early intravenous betablocker before reperfusion reduced infarct size and increased left ventricular ejection fraction (4).drug interactions are common in ACS patients due to polypharmacy and comorbidities.(5) there are limited studies investigating drug interactions with bisoprolol in acute coronary syndrome patients. The proposed research in this application will investigate potential drug interactions with bisoprolol in patients with acute coronary syndrome.

Detailed Description
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Ethical committee approval will be obtained from Ethics committee of Faculty of Pharmacy, Damanhour University. All participants should agree to take part in this clinical study and will provide informed consent. Over 100 patients diagnosed with acute coronary syndrome for whom bisoprolol therapy is prescribed , will be recruited from Alexandria university hospital. Blood samples for plasma concentration measurements of bisoprolol will be drawn at steady-state peak levels after 2-4 hours of administration of bisoprolol. 6. Heart rate and blood pressure of the patients will be measured to assess the clinical effect of bisoprolol.

Official Title
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Potential Drug Interactions With Bisoprolol in Egyptian Patients With Acute Coronary Syndrome

Conditions
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Acute Coronary Syndrome

Intervention / Treatment
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* Drug: Bisoprolol Fumarate Tablets


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients admitted with chest pain suspected to have ACS (acute coronary syndrome). Both with ST elevation (STEMI) and without ST elevation (N-STEMI ) and unstable angina. indicated to bisoprolol therapy Exclusion Criteria: Patients with contraindications to Bisoprolol therapy:
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acute coronary syndrome patients<br>Acute coronary syndrome patients that are prescribes bisoprolol | Drug: Bisoprolol Fumarate Tablets<br>* Antihypertensive drug used for acute coronary syndrome patients<br>* Other names: concor;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bisoprolol peak level | Bisoprolol peak concentration level | 6 months |