NCT03413410

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 11, 2018

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 29, 2018

Completed
3 days until next milestone

Study Start

First participant enrolled

February 1, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2020

Completed
Last Updated

July 19, 2019

Status Verified

July 1, 2019

Enrollment Period

1.5 years

First QC Date

January 11, 2018

Last Update Submit

July 18, 2019

Conditions

ACS - Acute Coronary Syndrome

Outcome Measures

Primary Outcomes (1)

  • percentage of patients achieving target dose

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

    1 month

Secondary Outcomes (3)

  • mean heart rate

    1 month

  • mean blood pressure

    1 month

  • percentage of patients who experienced bradycardia with symptoms

    1 month

Study Arms (1)

Metoprolol interventional group

EXPERIMENTAL

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

Interventions

MetoprololDRUG

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

Metoprolol interventional group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The General Hospital of PLA

Beijing, 100853, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 31806613DERIVED

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Metoprolol

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

PhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAmines

Study Officials

  • Yundai Chen, MD

    The General Hospital of PLA

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dandan Li, MD

CONTACT

+8613810545564ldd301heart@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 11, 2018

First Posted

January 29, 2018

Study Start

February 1, 2018

Primary Completion

July 30, 2019

Study Completion

July 30, 2020

Last Updated

July 19, 2019

Record last verified: 2019-07

Locations

CN(1)