NCT05536284

Potential Drug Interactions With Bisoprolol in Egyptian Patients With ACS

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 128 (actual)
• Sponsor: Damanhour University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Coronary Syndrome

Interventions

Type	Name	Description
DRUG	Bisoprolol Fumarate Tablets	Antihypertensive drug used for acute coronary syndrome patients

Timeline

• Start date: 2021-09-01
• Primary completion: 2022-05-20
• Completion: 2022-08-16
• First posted: 2022-09-10
• Last updated: 2023-06-07

Locations

1 site across 1 country: Egypt