Ignite Creation Date:
2024-05-06 @ 6:04 PM
Last Modification Date:
2024-10-26 @ 2:41 PM
Study NCT ID:
NCT05536271
Status:
COMPLETED
Last Update Posted:
2023-06-07
First Post:
2022-09-07
Brief Title:
Pharmacogenetic Study of Bisoprolol in Egyptian Patients With Acute Coronary Syndrome
Sponsor:
Damanhour University
Organization:
Damanhour University
Study Overview
Official Title:
Pharmacogenetic Study of Bisoprolol in Egyptian Patients With Acute Coronary Syndrome
Status:
COMPLETED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 83 2 In addition CHD in Egypt is the principal cause of death responsible for 2173 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 patients 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 kidney7 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 8The 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
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 patients 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 kidney7 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 8The 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:
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None