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

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 Overview

• Status: Unknown
• Conditions: ACS - Acute Coronary Syndrome
• Intervention / Treatment: Drug: Metoprolol

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.

• Study Type: Interventional
• Enrollment (Anticipated): 1000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100853
    • Recruiting
    • The General Hospital of PLA
    • Contact: Dandan Li, MD; Phone Number: +8613810545564; Email: ldd301heart@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Metoprolol; Patients with acute coronary syndrome take metoprolol during hospital and after discharge in the optimal dosing pathway.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
percentage of patients achieving target dose	The percentage of patients achieving target dose of 95mg/d at the time of discharge	1 month

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Yun Dai Chen
• Investigators: Principal Investigator: Yundai Chen, MD, The General Hospital of PLA

Publications and helpful links

General Publications

• Li D, Dong W, Liu Y, Wang J, Mu Y, Zhou H, Wang J, Zhou S, Chen Y. Impact of metoprolol standard dosing pathway in Chinese patients with acute coronary syndrome: protocol for a multicentre prospective study. BMJ Open. 2019 Dec 4;9(12):e031972. doi: 10.1136/bmjopen-2019-031972.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2018
• Primary Completion (Anticipated): July 30, 2019
• Study Completion (Anticipated): July 30, 2020

Study Registration Dates

• First Submitted: January 11, 2018
• First Submitted That Met QC Criteria: January 22, 2018
• First Posted (Actual): January 29, 2018

Study Record Updates

• Last Update Posted (Actual): July 19, 2019
• Last Update Submitted That Met QC Criteria: July 18, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Disease; Syndrome; Acute Coronary Syndrome; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Autonomic Agents; Peripheral Nervous System Agents; Sympatholytics; Adrenergic beta-1 Receptor Antagonists; Metoprolol
• Other Study ID Numbers: ESR-16-12344

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No