Prospective Assessment of Efficacy and Safety of Drug Eluting Stents

Coronary Heart Disease Clinical Trial

— PEACE-DES  

Official title:

Prospective Assessment of Efficacy and Safety of Drug Eluting Stents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02313038
• Other study ID #: MOST-2013BAI17B00
• Status: Completed
• Phase: N/A
• First received: February 5, 2014
• Last updated: August 27, 2015
• Start date: December 2013
• Est. completion date: July 2015

Study information

• Verified date: August 2015
• Source: China National Center for Cardiovascular Diseases
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Science and Technology
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Coronary heart disease (CHD) pose a serious health threat to population. PCI using drug eluting stents (DES), as a well-proved and booming measure in CHD management, is invasive and of high cost, however the knowledge about the real-life DES use and the efficacy and safety in China is limited. By consecutively recruiting first-ever PCI patients in 30 geographically representative highest-rank hospitals, this study will examine the prognosis in groups with different brands of DES, and various real-life factors, that may affect patients recovery after the procedure. Evidence for clinical practice and health resource allocation will be established based on the findings, to improve patients outcomes in future finally.

Description:

In this study, 6000 patients who underwent the first-ever drug eluting stents (DES) deployment during the index hospitalization will be consecutively recruited in 30 tertiary hospitals scattered all over China. At study entry, participants will be interviewed during their index hospitalization, to collect information about symptoms, functioning, quality of life, and medical care. Demographic characteristics, medical history, clinical features, diagnostic tests, medications, procedures, and in-hospital outcomes of patients will be abstracted from medical records by well trained professional abstractors. And CAG imaging will be reviewed by national and international expert panels. At 1 month, 6 month, and 12 month after discharge, participants will return to the clinic for follow up visits, a face-to-face interview will be conducted to get information about clinical events, symptoms, functioning, quality of life, and medical care during the recovery period. At 1-Month and 12-Month follow-up visit, blood and urine sample will be collected. Participants' blood samples will be stored for future biologic and genetic studies. This study will examine the prognosis in groups with different brands of DES, and various real-life factors, that may affect patients recovery after the procedure. Evidence for clinical practice and health resource allocation will be established based on the findings, to improve patients outcomes in future finally.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6023
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• At least one DES is implanted successfully in the procedure

• Only one of the five major brands of DES is used in the procedure

Exclusion Criteria:

• Prior stent implantation history

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Myocardial Ischemia

Locations

Country	Name	City	State
China	Fuwai hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
China National Center for Cardiovascular Diseases

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite of major adverse cardiac events (MACE)	Composite of major adverse cardiac events (MACE) including death, myocardial infarction, and/or revascularization.	1 year	Yes
Secondary	Safety endpoint	Safety endpoint: stent thrombosis	1 year	Yes
Secondary	Efficacy composite endpoints	Efficacy composite endpoints, including cardiac death, myocardial infarction (not clearly attributable to a nontarget vessel), and/or target lesion revascularization	1 year	No
Secondary	Status of general health	Status of general health (SF-12)	1 year	Yes
Secondary	Quality of life	Quality of life (EQ-5D)	1 year	Yes
Secondary	Symptoms status	Symptoms status (SAQ)	1 year	Yes
Secondary	Cost-effectiveness	Cost-effectiveness ratio: marginal cost (direct and indirect) per QALY increase, with homebred DES as the reference group	1 year	No