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

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ClinicalTrials.gov Identifier: NCT03413410
Recruitment Status : Recruiting
First Posted : January 29, 2018
Last Update Posted : January 29, 2018
Sponsor:
Information provided by (Responsible Party):
Yun Dai Chen, Chinese PLA General Hospital

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.

Condition or disease Intervention/treatment Phase
ACS - Acute Coronary Syndrome Drug: Metoprolol Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-Center Study on the Metoprolol Optimal Dosing Pathway of Metoprolol Application in Chinese Patients With Acute Coronary Syndrome
Actual Study Start Date : December 20, 2017
Estimated Primary Completion Date : July 30, 2019
Estimated Study Completion Date : July 30, 2020

Resource links provided by the National Library of Medicine


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.

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. mean heart rate [ Time Frame: 1 month ]
    The mean HR after achieving target dose

  2. mean blood pressure [ Time Frame: 1 month ]
    The mean BP after achieving target dose

  3. percentage of patients who experienced bradycardia with symptoms [ Time Frame: 1 month ]
    The percentage of patients who experienced bradycardia with symptoms during hospitalization and for 1 month after discharge, respectively



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03413410


Contacts
Contact: Dandan Li, MD +8613810545564 ldd301heart@qq.com

Locations
China
The General Hospital of PLA Recruiting
Beijing, China, 100853
Contact: Dandan Li, MD    +8613810545564    ldd301heart@qq.com   
Sponsors and Collaborators
Yun Dai Chen
Investigators
Principal Investigator: Yundai Chen, MD The General Hospital of PLA

Responsible Party: Yun Dai Chen, MD, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT03413410     History of Changes
Other Study ID Numbers: ESR-16-12344
First Posted: January 29, 2018    Key Record Dates
Last Update Posted: January 29, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Syndrome
Acute Coronary Syndrome
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Metoprolol
Anti-Arrhythmia Agents
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action