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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03658577
Other study ID # COE20180821
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 2, 2018
Est. completion date December 2023

Study information

Verified date August 2018
Source Shenzhen People's Hospital
Contact Feng Lin, MD
Phone +8613510730251
Email 119538892@qq.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Limited data are available on the efficacy of beta-blocker therapy for secondary prevention in Actue Coronary Syndrome(ACS) patients. This study sought to investigate the association of beta-blocker therapy at discharge with clinical outcomes in patients with ACS after percutaneous coronary intervention (PCI).


Description:

The American College of Cardiology (ACC)/American Heart Association (AHA) guidelines recommend beta-blockers for secondary prevention in patients with ACS without regard to reperfusion therapy. However, evidence supporting this recommendation originated from studies conducted before the introduction of reperfusion therapy or studies in patients treated with fibrinolysis. In the present era of PCI, there are no prospective randomized studies looking at the effects of long-term beta-blocker therapy on clinical outcomes in ACS patients. Moreover, results from registry data and post-hoc analysis on beta-blocker therapy in patients undergoing PCI are inconsistent.

In particular, the beneficial effect of long-term beta-blocker therapy has not been well established in patients with relatively low risk, such as preserved left ventricular systolic function or single-vessel disease. Therefore, we investigated the association of beta-blocker therapy at discharge with clinical outcomes in ACS patients after PCI.


Recruitment information / eligibility

Status Recruiting
Enrollment 582
Est. completion date December 2023
Est. primary completion date August 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. consecutive patients 18 years of age or older;

2. patients diagnosed as ACS(including STEMI?NSTEMI and UA) by doctor at discharge;

3. patients undergoing primary PCI.

Exclusion Criteria:

missing beta-blocker information.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
China Shenzhen People's Hospital Shenzhen Guangdong

Sponsors (1)

Lead Sponsor Collaborator
Shenzhen People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary all-cause death The primary outcome was all-cause death during follow up. 3 years
Secondary MACE Secondary outcomes included major adverse cardiac events (MACE), a composite of cardiac death, myocardial infarction, stroke, any revascularization during follow-up 3 year