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NCT Number: NCT05536284

Potential Drug Interactions With Bisoprolol in Egyptian Patients With ACS

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Damanhour University

Damanhur, Beheira, 22511, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:

Treatment and study plan

Bisoprolol Fumarate Tablets

Drug

Antihypertensive drug used for acute coronary syndrome patients

Other names: concor

Primary outcomes

  1. Bisoprolol peak level

    Time frame: 6 months

    Bisoprolol peak concentration level

Sponsors and collaborators

Lead sponsor

Damanhour University

Other

Collaborators

  • Alexandria University

Registry information

Official study title

Potential Drug Interactions With Bisoprolol in Egyptian Patients With Acute Coronary Syndrome

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 10, 2022
Registry last updated
Jun 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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