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Population Pharmacokinetics Of Bisoprolol in Egyptian Patients With ACS

Sponsor
Damanhour University (Other)
Overall Status
Completed
CT.gov ID
NCT05536284
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). The proposed research in this application will investigate population pharmacokinetics of bisoprolol in patients with acute coronary syndrome.

Condition or Disease Intervention/Treatment Phase
  • Drug: Bisoprolol Fumarate Tablets
 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. Blood samples for plasma concentration measurements of bisoprolol will be drawn at steady-state peak levels after 2-4 hours of administration of bisoprolol.

  5. Heart rate and blood pressure of the patients will be measured to assess the clinical effect of bisoprolol.

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:
Population Pharmacokinetics Of Bisoprolol in Egyptian Patients With Acute Coronary Syndrome
Actual Study Start Date :
Sep 1, 2021
Actual Primary Completion Date :
May 20, 2022
Actual Study Completion Date :
Aug 16, 2022

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Bisoprolol peak level [6 months]

      Bisoprolol peak concentration level

    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 Beheira Egypt 22511

    Sponsors and Collaborators

    • Damanhour University
    • Alexandria University

    Investigators

    • Study Director: Amira B Kassem, PHD, Lecturer of Clinical Pharmacy, Damanhour University.
    • Principal Investigator: sherouk okda, bachelor, Clinical Pharmacy Specialist, Damanhour University.
    • Study Chair: Noha ahmed, 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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Damanhour University
    ClinicalTrials.gov Identifier:
    NCT05536284
    Other Study ID Numbers:
    • BisoprololPK
    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
    Product Manufactured in and Exported from the U.S.:
    Yes
    Additional relevant MeSH terms:
    Acute Coronary Syndrome
    Syndrome
    Bisoprolol

    Study Results

    No Results Posted as of Sep 10, 2022