Prospective Assessment of Efficacy and Safety of Drug Eluting Stents
PEACE-DES
1 other identifier
observational
6,023
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2013
1 active site
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
December 1, 2013
CompletedFirst Submitted
Initial submission to the registry
February 5, 2014
CompletedFirst Posted
Study publicly available on registry
December 9, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedAugust 31, 2015
August 1, 2015
1.6 years
February 5, 2014
August 27, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Composite of major adverse cardiac events (MACE)
Composite of major adverse cardiac events (MACE) including death, myocardial infarction, and/or revascularization.
1 year
Secondary Outcomes (6)
Safety endpoint
1 year
Efficacy composite endpoints
1 year
Status of general health
1 year
Quality of life
1 year
Symptoms status
1 year
- +1 more secondary outcomes
Eligibility Criteria
Patients who underwent the first-ever DES deployment during the index hospitalization were consecutively recruited.
You may qualify if:
- At least one DES is implanted successfully in the procedure
- Only one of the five major brands of DES is used in the procedure
You may not qualify if:
- Prior stent implantation history
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fuwai hospital
Beijing, Beijing Municipality, 100037, China
Biospecimen
A venous blood sample of 20mL will be collected at 1-month visit and 12-month visit for biomarker analysis and storage for future genetic studies; A urine samples of 40mL will be collected at 1-month visit and 12-month visit for biomarker analysis and storage.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lixin Jiang, MD, PhD
China National Center for Cardiovascular Diseases
- PRINCIPAL INVESTIGATOR
Harlan M Krumholz, MD, SM
Yale University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Year
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 5, 2014
First Posted
December 9, 2014
Study Start
December 1, 2013
Primary Completion
July 1, 2015
Study Completion
July 1, 2015
Last Updated
August 31, 2015
Record last verified: 2015-08