- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03413410
A Multi-Center Study on the Metoprolol Optimal Dosing Pathway of Metoprolol Application in Chinese Patients With Acute Coronary Syndrome
Study Overview
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Dandan Li, MD
- Phone Number: +8613810545564
- Email: ldd301heart@qq.com
Study Locations
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Beijing, China, 100853
- Recruiting
- The General Hospital of PLA
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Contact:
- Dandan Li, MD
- Phone Number: +8613810545564
- Email: ldd301heart@qq.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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. |
Patients with acute coronary syndrome take metoprolol during hospital and after discharge in the optimal dosing pathway.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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1 month
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
mean heart rate
Time Frame: 1 month
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The mean HR after achieving target dose
|
1 month
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mean blood pressure
Time Frame: 1 month
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The mean BP after achieving target dose
|
1 month
|
percentage of patients who experienced bradycardia with symptoms
Time Frame: 1 month
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The percentage of patients who experienced bradycardia with symptoms during hospitalization and for 1 month after discharge, respectively
|
1 month
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Yundai Chen, MD, The General Hospital of PLA
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Myocardial Ischemia
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Disease
- Syndrome
- Acute Coronary Syndrome
- Physiological Effects of Drugs
- Adrenergic beta-Antagonists
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Antihypertensive Agents
- Autonomic Agents
- Peripheral Nervous System Agents
- Sympatholytics
- Adrenergic beta-1 Receptor Antagonists
- Metoprolol
Other Study ID Numbers
- ESR-16-12344
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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