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

ACS - Acute Coronary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03413410
• Other study ID #: ESR-16-12344
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2018
• Est. completion date: July 30, 2020

Study information

• Verified date: July 2019
• Source: Chinese PLA General Hospital
• Contact: Dandan Li, MD
• Phone: +8613810545564
• Email: ldd301heart[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: July 30, 2020
• Est. primary completion date: July 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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;

• ?~? atrioventricular block;

• Killip >?;

• 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.

Related Conditions & MeSH terms

• ACS - Acute Coronary Syndrome
• Acute Coronary Syndrome
• Syndrome

Intervention

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

Locations

Country	Name	City	State
China	The General Hospital of PLA	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Yun Dai Chen

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percentage of patients achieving target dose	The percentage of patients achieving target dose of 95mg/d at the time of discharge	1 month
Secondary	mean heart rate	The mean HR after achieving target dose	1 month
Secondary	mean blood pressure	The mean BP after achieving target dose	1 month
Secondary	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