Ignite Creation Date:
2024-05-06 @ 6:04 PM
Last Modification Date:
2024-10-26 @ 2:41 PM
Study NCT ID:
NCT05536284
Status:
COMPLETED
Last Update Posted:
2023-06-07
First Post:
2022-09-07
Brief Title:
Potential Drug Interactions With Bisoprolol in Egyptian Patients With ACS
Sponsor:
Damanhour University
Organization:
Damanhour University
Study Overview
Official Title:
Potential Drug Interactions With 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 4drug interactions are common in ACS patients due to polypharmacy and comorbidities5 there are limited studies investigating drug interactions with bisoprolol in acute coronary syndrome patients The proposed research in this application will investigate potential drug interactions with 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 4drug interactions are common in ACS patients due to polypharmacy and comorbidities5 there are limited studies investigating drug interactions with bisoprolol in acute coronary syndrome patients The proposed research in this application will investigate potential drug interactions with 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 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
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
6 Heart rate and blood pressure of the patients will be measured to assess the clinical effect of bisoprolol
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?:
True
Is an FDA AA801 Violation?:
None