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

Not Applicable

• Conditions: ACS - Acute Coronary Syndrome
• Interventions: Drug: Metoprolol

• Registration Number: NCT03413410
• Lead Sponsor: Yun Dai Chen

Brief Summary

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.

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 Timeline

• Study First Submitted: 2018-01-11
• Study First Submitted QC: 2018-01-22
• Study First Posted: 2018-01-29
• Study Start: 2018-02-01
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-18
• Last Update Posted: 2019-07-19
• Primary Completion: 2019-07-30
• Study Completion: 2020-07-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Metoprolol interventional group	Metoprolol	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.

Primary Outcome Measures

Name	Time	Method
percentage of patients achieving target dose	1 month	The percentage of patients achieving target dose of 95mg/d at the time of discharge

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The General Hospital of PLA; 🇨🇳 Beijing, China