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Pharmacogenetic Study of Bisoprolol in Egyptian Patients With Acute Coronary Syndrome

Primary Purpose

Acute Coronary Syndrome

Status

Completed

Phase

Phase 2

Locations

Egypt

Study Type

Interventional

Intervention

Bisoprolol Fumarate

About this trial

This is an interventional treatment trial for Acute Coronary Syndrome

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients admitted with chest pain suspected to have ACS (acute coronary syndrome).
Both with ST elevation (STEMI) and without ST elevation (N-STEMI ) and unstable angina.
HR > 50 bpm.
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.

Sites / Locations

Damanhour University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Acute coronary syndrome patients

Arm Description

Acute coronary syndrome patients prescribed with bisoprolol

Outcomes

Primary Outcome Measures

CYP2D6 gene polymorphism

CYP3A5 gene polymorphism

Secondary Outcome Measures

Full Information

NCT ID

NCT05536271

First Posted

September 7, 2022

Last Updated

June 6, 2023

Sponsor

Damanhour University

Collaborators

Alexandria University

1. Study Identification

Unique Protocol Identification Number

NCT05536271

Brief Title

Pharmacogenetic Study of Bisoprolol in Egyptian Patients With Acute Coronary Syndrome

Official Title

Pharmacogenetic Study of Bisoprolol in Egyptian Patients With Acute Coronary Syndrome

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Completed

Study Start Date

September 1, 2021 (Actual)

Primary Completion Date

June 1, 2022 (Actual)

Study Completion Date

August 16, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Damanhour University

Collaborators

Alexandria University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

Detailed Description

Ethical committee approval will be obtained from Ethics committee of Faculty of Pharmacy, Damanhour University. All participants should agree to take part in this clinical study and will provide informed consent. Over 100 patients diagnosed with acute coronary syndrome for whom bisoprolol therapy is prescribed , will be recruited from Alexandria university hospital. whole blood samples will be collected for Analyses of CYP2D6 and CYP3A4 variant alleles. Blood samples for plasma concentration measurements of bisoprolol will be drawn at steady-state peak levels after 2-4 hours of administration of bisoprolol. Heart rate and blood pressure of the patients will be measured to assess the clinical effect of bisoprolol. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Coronary Syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

127 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Acute coronary syndrome patients

Arm Type

Experimental

Arm Description

Acute coronary syndrome patients prescribed with bisoprolol

Intervention Type

Drug

Intervention Name(s)

Bisoprolol Fumarate

Other Intervention Name(s)

concor

Intervention Description

antihypertensive medicine prescribed for acute coronary syndrome patients

Primary Outcome Measure Information:

Title

CYP2D6 gene polymorphism

Description

CYP2D6 gene polymorphism

Time Frame

2 months

Title

CYP3A5 gene polymorphism

Description

CYP3A5 gene polymorphism

Time Frame

2 months

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients admitted with chest pain suspected to have ACS (acute coronary syndrome). Both with ST elevation (STEMI) and without ST elevation (N-STEMI ) and unstable angina. HR > 50 bpm. 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.

Overall Study Officials: