Pharmacogenetic Study of Bisoprolol in Egyptian Patients With Acute Coronary Syndrome

June 6, 2023 updated by: Damanhour University

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). Despite the established benefits of beta blockers in ACS (acute coronary syndrome patients), they showed interindividual variability in patient's' blood pressure and heart rate (5).

pharmacokinetic variability was found in bisoprolol response especially in elderly patients (6). Bisoprolol is eliminated in equal parts by hepatic metabolism by CYP2D6 and CYP3A4 enzymes and by the kidney(7). A possible cause for this variability may be due to CYP450 genetic polymorphism. The CYP450 activity ranges considerably within a population and includes ultrarapid metabolizers (UMs), extensive metabolizers (EMs), intermediate metabolizers (IMs) and poor metabolizers (PMs) (8).The proposed research in this application will investigate the correlation between CYP2D6 and CYP3A4 polymorphism and pharmacokinetics of bisoprolol and will investigate the impact of the Genes' polymorphism on the clinical effect of 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. whole blood samples will be collected for Analyses of CYP2D6 and CYP3A4 variant alleles.
  5. 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.
  7. Echocardiogram will be obtained at baseline and after 1-3 months of therapy with bisoprolol to assess the effect of the drug on ventricular Remodeling.

Study Type

Interventional

Enrollment (Actual)

127

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
    • Behira
      • Damanhūr, Behira, 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. HR > 50 bpm.
  4. Systolic Blood pressure > 90 mmHg.

Exclusion Criteria:

Patients with contraindications to Bisoprolol therapy:

  • Heart rate <60 bpm
  • Systolic blood pressure <90 mmHg
  • Moderate or severe left ventricular failure
  • Shock
  • heart block
  • Active asthma/reactive airways disease.

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 prescribed with bisoprolol
Drug: Bisoprolol Fumarate
antihypertensive medicine prescribed for acute coronary syndrome patients
Other Names:
  • concor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CYP2D6 gene polymorphism
Time Frame: 2 months
CYP2D6 gene polymorphism
2 months
CYP3A5 gene polymorphism
Time Frame: 2 months
CYP3A5 gene polymorphism
2 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: noha ahmad, PHD, Lecturer of Clinical Pharmacy, Damanhour University.
  • Study Chair: sohila alonsy, PHD, Lecturer of Analytical chemistry, 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)

June 1, 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

  • BisoprololPG

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

No

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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