ClinicalTrials.gg
Status unknownNCT03413410Updated Jul 19, 2019

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

An interventional study of Metoprolol in ACS - Acute Coronary Syndrome, sponsored by Yun Dai Chen. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-07-19.

Sponsored by Yun Dai Chen · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2019), so the status shown — last known as Recruiting — may be out of date.

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Phase
Not applicable
Study type
Interventional
Enrollment
1,000
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 185 studies in Acute Coronary Syndrome with a site in China — 56 open to participants now, 63 under way, 3 of them phase 3. Acute Coronary Syndrome · China.

Planned enrollment
48th of 115
1,000 · median 499
Started
2018
with 12 others
No phase
47 of 185
20 open now
Registered
71st of 185
by date

Among the 185 studies in Acute Coronary Syndrome with a site in China, this one is the 48th largest by planned enrollment of the 115 interventional ones that give a count, is one of 13 that started in 2018, is one of 47 with no phase, and was the 71st registered.

Acute Coronary Syndrome

1,490 studies on the registry are indexed under Acute Coronary Syndrome; 272 are open to participants now.

Browse Acute Coronary Syndrome studies →

Open to participants now

56 of the 185 studies in Acute Coronary Syndrome with a site in China are open now. Recruiting first, the newest first:

51 more — sign in →

All 56 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 196 Acute Coronary Syndrome studies recruiting now, 145 (74%) set no upper age limit and 19 (10%) stop at 75 or younger; 15 take children under 18; 15 take healthy volunteers.

This study: 18 Years to 80 Years · all sexes · no healthy volunteers.

The full table on the hub →

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02

Study 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.

Read the 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.

03

Conditions studied

  • ACS - Acute Coronary Syndrome
04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Aged 18 years or above;
  • Hospitalized due to acute coronary syndrome;
  • Able and willing to provide written and to comply with the study.

Exclusion criteria

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 for metoprolol or allergic to metoprolol or any ;
  • Participation in another clinical study with an 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 form;
  • Pregnancy or lactation.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
1,000 participants (estimated)

Study arms

  • Experimental
    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.

    Drug: Metoprolol

Interventions

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

06

What researchers measure

Primary outcomes

  1. percentage of patients achieving target dose

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

    Time frame: 1 month

Secondary outcomes

  1. mean heart rate

    The mean HR after achieving target dose

    Time frame: 1 month

  2. mean blood pressure

    The mean BP after achieving target dose

    Time frame: 1 month

  3. 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

    Time frame: 1 month

07

Study locations

1 of 1 sites recruiting
  • The General Hospital of PLA
    Beijing, 100853, China
    Recruiting
08

References and documents

Publications

  • 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. PubMed 31806613 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Feb 2018 (actual). Primary completion is estimated for Jul 2019, 17 months after the start.

Of 213 non-industry interventional studies with no phase under Acute Coronary Syndrome, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 46. This study's planned 17 months is below that.

Counting every sponsor, half of 228 studies reached it within 34 months; a quarter within 17 and three quarters within 46.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 11, 2018
First posted
Jan 29, 2018
StartActual
Feb 1, 2018
Primary completionEst.
Jul 30, 2019
CompletionEst.
Jul 30, 2020
Last update
Jul 19, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 19, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03413410
Lead sponsor
Yun Dai Chen
Responsible party
Yun Dai Chen (MD, Chinese PLA General Hospital) — Sponsor-investigator
First posted
Jan 29, 2018
Start date
Feb 1, 2018
Primary completion
Jul 30, 2019 (estimated)
Completion
Jul 30, 2020 (estimated)
Last update
Jul 19, 2019

Study contacts

Dandan Li, MD
Contact
ldd301heart@qq.com
+8613810545564
Yundai Chen, MD
principal investigator · The General Hospital of PLA

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Metoprolol

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