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Potential Drug Interactions With Bisoprolol in Egyptian Patients With ACS

Primary Purpose

Acute Coronary Syndrome

Status

Completed

Phase

Phase 2

Locations

Egypt

Study Type

Interventional

Intervention

Bisoprolol Fumarate Tablets

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 that are prescribes bisoprolol

Outcomes

Primary Outcome Measures

Bisoprolol peak level

Bisoprolol peak concentration level

Secondary Outcome Measures

Full Information

NCT ID

NCT05536284

First Posted

September 7, 2022

Last Updated

June 6, 2023

Sponsor

Damanhour University

Collaborators

Alexandria University

1. Study Identification

Unique Protocol Identification Number

NCT05536284

Brief Title

Potential Drug Interactions With Bisoprolol in Egyptian Patients With ACS

Official Title

Potential Drug Interactions With 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

May 20, 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

Product Manufactured in and Exported from the U.S.

Yes

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).drug interactions are common in ACS patients due to polypharmacy and comorbidities.(5) 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

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. 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.

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

128 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Acute coronary syndrome patients

Arm Type

Experimental

Arm Description

Acute coronary syndrome patients that are prescribes bisoprolol

Intervention Type

Drug

Intervention Name(s)

Bisoprolol Fumarate Tablets

Other Intervention Name(s)

concor

Intervention Description

Antihypertensive drug used for acute coronary syndrome patients

Primary Outcome Measure Information:

Title

Bisoprolol peak level

Description

Bisoprolol peak concentration level

Time Frame

6 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. indicated to bisoprolol therapy Exclusion Criteria: Patients with contraindications to Bisoprolol therapy:

Overall Study Officials: