Potential Drug Interactions With Bisoprolol in Egyptian Patients With ACS

Phase 2

Completed

• Conditions: Acute Coronary Syndrome
• Interventions: Drug: Bisoprolol Fumarate Tablets

• Registration Number: NCT05536284
• Lead Sponsor: Damanhour University

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.

Study Timeline

• Study Start: 2021-09-01
• Primary Completion: 2022-05-20
• Study Completion: 2022-08-16
• Study First Submitted: 2022-09-07
• Study First Submitted QC: 2022-09-07
• Study First Posted: 2022-09-10
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-06
• Last Update Posted: 2023-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 128

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:

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Acute coronary syndrome patients	Bisoprolol Fumarate Tablets	Acute coronary syndrome patients that are prescribes bisoprolol

Primary Outcome Measures

Name	Time	Method
Bisoprolol peak level	6 months	Bisoprolol peak concentration level

Trial Locations

Locations (1)

Damanhour University; 🇪🇬 Damanhūr, Beheira, Egypt