A Multi-Center Study on the Metoprolol Optimal Dosing Pathway of Metoprolol Application in Chinese Patients With Acute Coronary Syndrome

Overview

This study is to test the feasibility and tolerability of the metoprolol optimal dosing pathway by observing the percentage of patients achieving target dose followed the pathway on ACS patients during hospitalization.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 30, 2019

Detailed Description

Acute coronary syndrome(ACS) is one of the main manifestations of cardiovascular disease and one of the main causes for hospitalization in adults. Previous studies showed that β-receptor blockers can reduce ACS patients' cardiovascular risk in both acute phase and secondary prevention. We summarized the metoprolol optimal dosing pathway based on Chinese and foreign guidelines as well as Chinese clinical practice. Primary endpoint is the percentage of patients achieving target dose at time of discharge. Secondary endpoints are the mean HR & BP at discharge and during the follow up period of the Patients who have achieved target dose at discharge.

Interventions

  • Drug: Metoprolol
    • Patients with acute coronary syndrome take metoprolol during hospital and after discharge in the optimal dosing pathway.

Arms, Groups and Cohorts

  • Experimental: Metoprolol interventional group
    • This is a multi-center, prospective, open label, single-arm interventional study. Patients hospitalized for ACS, fulfilling all of the inclusion criteria and none of the exclusion criteria can be enrolled in this study.

Clinical Trial Outcome Measures

Primary Measures

  • percentage of patients achieving target dose
    • Time Frame: 1 month
    • The percentage of patients achieving target dose of 95mg/d at the time of discharge

Secondary Measures

  • mean heart rate
    • Time Frame: 1 month
    • The mean HR after achieving target dose
  • mean blood pressure
    • Time Frame: 1 month
    • The mean BP after achieving target dose
  • percentage of patients who experienced bradycardia with symptoms
    • Time Frame: 1 month
    • The percentage of patients who experienced bradycardia with symptoms during hospitalization and for 1 month after discharge, respectively

Participating in This Clinical Trial

Inclusion Criteria

  • Aged 18 years or above; – Hospitalized due to acute coronary syndrome; – Able and willing to provide written informed consent and to comply with the study. Exclusion Criteria:

  • Cardiac shock; – Unstable heart failure; – Beta-agonist therapy on a continuous or intermittent basis; – Hypotension (BP<90/60 mmHg) or bradycardia (HR<50 bpm) with symptoms; – Sick sinus syndrome; – Ⅱ~Ⅲ atrioventricular block; – Killip >Ⅱ; – Suspected acute myocardial infarction with heart rate<45 beats/min, P- R interval>0.24 sec or systolic blood pressure <100 mmHg; – Existing contraindication for metoprolol or allergic to metoprolol or any excipients; – Participation in another clinical study with an investigational product during the last 3 months; – Previous enrolment in the present study; – Subjects the investigator thinks not suitable for this study. E.g. cancer etc.; – Inability to sign the informed consent form; – Pregnancy or lactation.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Yun Dai Chen
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Yun Dai Chen, MD – Chinese PLA General Hospital
  • Overall Official(s)
    • Yundai Chen, MD, Principal Investigator, The General Hospital of PLA
  • Overall Contact(s)
    • Dandan Li, MD, +8613810545564, ldd301heart@qq.com

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