Clinical trial NCT03413410: 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
Overall status: UNKNOWN
Phase: NA
Conditions: ACS - Acute Coronary Syndrome
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2018-01-29
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: percentage of patients achieving target dose
timeFrame: 1 month
Secondary outcomes:
measure: mean heart rate
timeFrame: 1 month
measure: mean blood pressure
timeFrame: 1 month
measure: percentage of patients who experienced bradycardia with symptoms
timeFrame: 1 month
Other outcomes:
Locations:
city: Beijing
country: China
facility: The General Hospital of PLA
Study officials:
affiliation: The General Hospital of PLA
name: Yundai Chen, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.