Potential Drug Interactions With Bisoprolol in Egyptian Patients With ACS

June 6, 2023 updated by: Damanhour University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

128

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Beheira
      • Damanhūr, Beheira, Egypt, 22511
        • Damanhour University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Acute coronary syndrome patients
Acute coronary syndrome patients that are prescribes bisoprolol
Drug: Bisoprolol Fumarate Tablets
Antihypertensive drug used for acute coronary syndrome patients
Other Names:
  • concor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bisoprolol peak level
Time Frame: 6 months
Bisoprolol peak concentration level
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Damanhour University

Collaborators

Alexandria University

Investigators

  • Principal Investigator: sherouk okda, bachelor, Clinical Pharmacy Specialist, Damanhour University.
  • Study Director: Amira B Kassem, PhD, Lecturer of Clinical Pharmacy, Damanhour University.
  • Study Director: ahmad salahaldin, PHD, Lecturer of biochemisrty, Damanhour University.
  • Study Chair: ahmad alamrawy, PHD, cardiologist , alexandria university
  • Study Chair: sohila alonsy, PHD, Lecturer of Analytical chemistry, Damanhour University.
  • Study Chair: Noha ahmed, PHD, Lecturer of Clinical Pharmacy, Damanhour University.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2021

Primary Completion (Actual)

May 20, 2022

Study Completion (Actual)

August 16, 2022

Study Registration Dates

First Submitted

September 7, 2022

First Submitted That Met QC Criteria

September 7, 2022

First Posted (Actual)

September 10, 2022

Study Record Updates

Last Update Posted (Actual)

June 7, 2023

Last Update Submitted That Met QC Criteria

June 6, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BisoprololDDI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The summary of all relevant data

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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