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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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ACS - Acute Coronary Syndrome

Intervention / Treatment
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* Drug: Metoprolol


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Metoprolol interventional group<br>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<br>* Patients with acute coronary syndrome take metoprolol during hospital and after discharge in the optimal dosing pathway.<br>|

What is the study measuring?
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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 |