Association of Beta-Blocker Therapy at Discharge With Clinical Outcomes in Patients With Actue Coronary Syndrome

Association of Beta-Blocker Therapy at Discharge With Clinical Outcomes in Patients With Actue Coronary Syndrome Undergoing Percutaneous Coronary Intervention

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).

Study Overview

• Status: Recruiting
• Conditions: Actue Coronary Syndrome

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 582

Contacts and Locations

• Study Contact: Name: Feng Lin, MD; Phone Number: +8613510730251; Email: 119538892@qq.com
• Study Contact Backup: Name: Xia Liu, PhD; Phone Number: +8613602552203; Email: lf.sakula@qq.com

Study Locations

• China
  • Guangdong
    • Shenzhen, Guangdong, China, 518020
      • Recruiting
      • ShenZhen People's Hospital
      • Contact: Feng Lin, MD; Phone Number: +8613510730251; Email: 119538892@qq.com
      • Contact: ShaoHong Dong, PhD; Phone Number: +8613509633742; Email: dsh266@outlook.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The study population was selected from ten major cardiac centres in ShenZhen,CHINA.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
all-cause death	The primary outcome was all-cause death during follow up.	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MACE	Secondary outcomes included major adverse cardiac events (MACE), a composite of cardiac death, myocardial infarction, stroke, any revascularization during follow-up	3 year

Collaborators and Investigators

• Sponsor: Shenzhen People's Hospital
• Investigators: Principal Investigator: ShaoHong P Dong, PhD, professor, Chief of cardiovascular department

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2018
• Primary Completion (Anticipated): August 1, 2019
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: August 20, 2018
• First Submitted That Met QC Criteria: September 1, 2018
• First Posted (Actual): September 5, 2018

Study Record Updates

• Last Update Posted (Actual): September 5, 2018
• Last Update Submitted That Met QC Criteria: September 1, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Percutaneous Coronary Intervention; Beta-Blocker; Actue Coronary Syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Syndrome
• Other Study ID Numbers: COE20180821

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No