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

Primary Purpose

ACS - Acute Coronary Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Metoprolol
Sponsored by
Yun Dai Chen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ACS - Acute Coronary Syndrome

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The General Hospital of PLARecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Metoprolol interventional group

Arm Description

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.

Outcomes

Primary Outcome Measures

percentage of patients achieving target dose
The percentage of patients achieving target dose of 95mg/d at the time of discharge

Secondary Outcome Measures

mean heart rate
The mean HR after achieving target dose
mean blood pressure
The mean BP after achieving target dose
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

Full Information

First Posted
January 11, 2018
Last Updated
July 18, 2019
Sponsor
Yun Dai Chen
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1. Study Identification

Unique Protocol Identification Number
NCT03413410
Brief Title
A Multi-Center Study on the Metoprolol Optimal Dosing Pathway of Metoprolol Application in Chinese Patients With Acute Coronary Syndrome
Official Title
A Multi-Center Study on the Metoprolol Optimal Dosing Pathway of Metoprolol Application in Chinese Patients With Acute Coronary Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
July 30, 2019 (Anticipated)
Study Completion Date
July 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yun Dai Chen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ACS - Acute Coronary Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Metoprolol interventional group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Metoprolol
Intervention Description
Patients with acute coronary syndrome take metoprolol during hospital and after discharge in the optimal dosing pathway.
Primary Outcome Measure Information:
Title
percentage of patients achieving target dose
Description
The percentage of patients achieving target dose of 95mg/d at the time of discharge
Time Frame
1 month
Secondary Outcome Measure Information:
Title
mean heart rate
Description
The mean HR after achieving target dose
Time Frame
1 month
Title
mean blood pressure
Description
The mean BP after achieving target dose
Time Frame
1 month
Title
percentage of patients who experienced bradycardia with symptoms
Description
The percentage of patients who experienced bradycardia with symptoms during hospitalization and for 1 month after discharge, respectively
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dandan Li, MD
Phone
+8613810545564
Email
ldd301heart@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yundai Chen, MD
Organizational Affiliation
The General Hospital of PLA
Official's Role
Principal Investigator
Facility Information:
Facility Name
The General Hospital of PLA
City
Beijing
ZIP/Postal Code
100853
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dandan Li, MD
Phone
+8613810545564
Email
ldd301heart@qq.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31806613
Citation
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.
Results Reference
derived

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

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