Clinical trial NCT05536284: Potential Drug Interactions With Bisoprolol in Egyptian Patients With ACS
Official title: Potential Drug Interactions With Bisoprolol in Egyptian Patients With Acute Coronary Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Coronary Syndrome
Lead sponsor: Damanhour University
Sponsor class: OTHER
Collaborators: name: Alexandria University
First posted: 2022-09-10
Enrollment: 128
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: 1. Ethical committee approval will be obtained from Ethics committee of Faculty of Pharmacy, Damanhour University.
2. All participants should agree to take part in this clinical study and will provide informed consent.
3. Over 100 patients diagnosed with acute coronary syndrome for whom bisoprolol therapy is prescribed , will be recruited from Alexandria university hospital.
4. 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.

Eligibility criteria: Inclusion Criteria:

1. Patients admitted with chest pain suspected to have ACS (acute coronary syndrome).
2. Both with ST elevation (STEMI) and without ST elevation (N-STEMI ) and unstable angina.
3. indicated to bisoprolol therapy

Exclusion Criteria:

Patients with contraindications to Bisoprolol therapy:

Primary outcomes:
measure: Bisoprolol peak level
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Damanhūr
country: Egypt
facility: Damanhour University
state: Beheira
Study officials:
affiliation: Lecturer of Clinical Pharmacy, Damanhour University.
name: Amira B Kassem, PHD
role: STUDY_DIRECTOR
affiliation: Clinical Pharmacy Specialist, Damanhour University.
name: sherouk okda, bachelor
role: PRINCIPAL_INVESTIGATOR
affiliation: Lecturer of Clinical Pharmacy, Damanhour University.
name: Noha ahmed, PHD
role: STUDY_CHAIR
affiliation: Lecturer of biochemisrty, Damanhour University.
name: ahmad salahaldin, PHD
role: STUDY_DIRECTOR
affiliation: cardiologist , alexandria university
name: ahmad alamrawy, PHD
role: STUDY_CHAIR
affiliation: Lecturer of Analytical chemistry, Damanhour University.
name: sohila alonsy, PHD
role: STUDY_CHAIR
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