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

NCT ID: NCT03413410

Last Updated: 2019-07-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 1000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-01
• Study Completion Date: 2020-07-30

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.

Conditions

ACS - Acute Coronary Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Metoprolol

Intervention Type: DRUG

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

Interventions

Metoprolol

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yun Dai Chen

OTHER

Sponsor Role: lead

Responsible Party

Yun Dai Chen

MD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Yundai Chen, MD

Role: PRINCIPAL_INVESTIGATOR

The General Hospital of PLA

Locations

The General Hospital of PLA

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Dandan Li, MD

Role: CONTACT

ldd301heart@qq.com

+8613810545564

Facility Contacts

Dandan Li, MD

Role: primary

ldd301heart@qq.com

+8613810545564

References

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.

Reference Type: DERIVED

PMID: 31806613 (View on PubMed)

Other Identifiers

ESR-16-12344

Identifier Type: -

Identifier Source: org_study_id