NCT03669991

Brief Summary

The study is aimed to optimized the dose-adjusted regimen of beta-blockers in patients with acute coronary syndrome by investigating therapeutic and curative results of target doses Beta-blockers using the dose-adjusted pathway of beta-blockers.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 31, 2018

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

September 3, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 13, 2018

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2022

Completed
Last Updated

September 17, 2018

Status Verified

September 1, 2018

Enrollment Period

3.3 years

First QC Date

September 3, 2018

Last Update Submit

September 13, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Major adverse cardiovascular and cerebrovascular events (MACCE)

    MACCE were defined as a composite of all-cause death, myocardial infarction (MI), unplanned target vessel revascularization (TVR), stent thrombosis (ST) and stroke.

    Within 1 year after surgery

Secondary Outcomes (4)

  • Resting heart rate

    Within 1 year after surgery

  • Blood pressure (systolic & diastolic)

    Within 1 year after surgery

  • Ejection fraction

    Within 1 year after surgery

  • Serum norepinephrine

    Within 1 year after surgery

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with acute coronary syndrome

You may qualify if:

  • Age ≥ 18 years
  • Patients diagnosed as acute coronary syndromes including acute ST-segment elevation myocardial infarction (STEMI) and non-ST-segment elevated acute coronary syndrome (NSTE-ACS)
  • Patients or whose legal representatives signed written informed consent form

You may not qualify if:

  • Patients with contraindications to the application of beta blockers, including: 1) cardiogenic shock or heart failure (Killip grade \> II level);2) sick sinus syndrome; 3) II degree atrioventricular block;4) unstable decompensation of cardiac failure (pulmonary edema, hypotension or low perfusion); 5) symptomatic hypotension or bradycardia (heart rate\<50 beats/min, blood pressure\<90/60mmHg); 6) contraindications to beta blockers or allergy to any ingredient of beta blocker; 7) active asthma should be treated by inhalation preparation treatment
  • Pregnant or lactating women
  • Patients without signed written informed consent
  • Patients who was considered by the researcher inappropriate to participate in this study (for example, patients with a higher risk of cardiogenic shock, etc.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fuwai Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100037, China

RECRUITING

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Yi-Da Tang, MD

    Chinese Academy of Medical Sciences, Fuwai Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 3, 2018

First Posted

September 13, 2018

Study Start

August 31, 2018

Primary Completion

December 31, 2021

Study Completion

July 31, 2022

Last Updated

September 17, 2018

Record last verified: 2018-09

Locations