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Pharmacogenetic Study of Bisoprolol in Egyptian Patients With Acute Coronary Syndrome

Sponsor
Damanhour University (Other)
Overall Status
Completed
CT.gov ID
NCT05536271
Collaborator
Alexandria University (Other)
127
Enrollment
1
Location
1
Arm
11.5
Actual Duration (Months)
11.1
Patients Per Site Per Month

Study Details

Study Description

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). 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Bisoprolol Fumarate
 Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
127 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Pharmacogenetic Study of Bisoprolol in Egyptian Patients With Acute Coronary Syndrome
Actual Study Start Date :
Sep 1, 2021
Actual Primary Completion Date :
Jun 1, 2022
Actual Study Completion Date :
Aug 16, 2022

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. CYP2D6 gene polymorphism [2 months]

      CYP2D6 gene polymorphism

    2. CYP3A4 gene polymorphism [2 months]

      CYP3A4 gene polymorphism

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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 > 100 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Damanhour University Damanhūr Behira Egypt 22511

    Sponsors and Collaborators

    • Damanhour University
    • 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.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Damanhour University
    ClinicalTrials.gov Identifier:
    NCT05536271
    Other Study ID Numbers:
    • BisoprololPG
    First Posted:
    Sep 10, 2022
    Last Update Posted:
    Sep 10, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Acute Coronary Syndrome
    Syndrome
    Bisoprolol

    Study Results

    No Results Posted as of Sep 10, 2022