ACS - Acute Coronary SyndromeNCT03413410
A Multi-Center Study on the Metoprolol Optimal Dosing Pathway of Metoprolol Application in Chinese Patients With Acute Coronary Syndrome
A study testing Metoprolol in people with ACS - Acute Coronary Syndrome, run by Yun Dai Chen at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- ACS - Acute Coronary Syndrome
- What is being tested?
- Metoprolol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2018to 30 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The General Hospital of PLA
Beijing, 100853
Dandan Li, MD, +8613810545564, ldd301heart@qq.com
About this study
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.
- Conditions
- ACS - Acute Coronary Syndrome
- Being tested
- Metoprolol
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetoprololDrug
Patients with acute coronary syndrome take metoprolol during hospital and after discharge in the optimal dosing pathway.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Metoprolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of patients achieving target dose
The percentage of patients achieving target dose of 95mg/d at the time of discharge
Measured: 1 month
Secondary outcomes (3)
mean heart rate
The mean HR after achieving target dose
Measured: 1 month
mean blood pressure
The mean BP after achieving target dose
Measured: 1 month
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
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2018
- Study start1 Feb 2018
- Primary completion30 Jul 2019 (estimated)
- Study completion30 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ACS - Acute Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yun Dai Chen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yun Dai Chen, Chinese PLA General Hospital
- Investigators
- Yundai Chen, MD, Principal investigator, The General Hospital of PLA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03413410
- Sponsor's protocol ID
- ESR-16-12344
- Status last verified
- Jul 2019
- First submitted
- 11 Jan 2018
- Last updated
- 19 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center Study on the Metoprolol Optimal Dosing Pathway of Metoprolol Application in Chinese Patients With Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT03413410
- Acronym / sponsor ID
- ESR-16-12344
- Conditions
- ACS - Acute Coronary Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Yun Dai ChenUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 30 Jul 2019 (estimated)
- Study completion
- 30 Jul 2020 (estimated)
- First posted
- 29 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Metoprolol interventional group | Experimental | Drug: MetoprololThis 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (14 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MetoprololPatients with acute coronary syndrome take metoprolol during hospital and after discharge in the optimal dosing pathway. | Drug | Metoprolol interventional group |
Primary outcome
percentage of patients achieving target dose
Time frame: 1 month
The percentage of patients achieving target dose of 95mg/d at the time of discharge
3 secondary outcomes
mean heart rate
Time frame: 1 month
mean blood pressure
Time frame: 1 month
percentage of patients who experienced bradycardia with symptoms
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2019.
- Derived from this study: PubMed 31806613Li 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yundai Chen, MD principal investigator
The General Hospital of PLA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metoprolol in people with ACS - Acute Coronary Syndrome, run by Yun Dai Chen at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dandan Li, MD (+8613810545564, ldd301heart@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of patients achieving target dose (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03413410, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2019; AzTrials last refreshed its copy on 30 Oct 2026.