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临床试验/NCT05536284
NCT05536284已完成2 期

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

Damanhour University1 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2021年9月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
128
试验地点
1
主要终点
Bisoprolol peak level

研究概览

简要总结

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.

详细描述

  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.

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

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Patients with contraindications to Bisoprolol therapy:

研究组 & 干预措施

Acute coronary syndrome patients

Experimental

Acute coronary syndrome patients that are prescribes bisoprolol

干预措施: Bisoprolol Fumarate Tablets (Drug)

结局指标

主要结局

Bisoprolol peak level

时间窗: 6 months

Bisoprolol peak concentration level

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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