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Factors Contribute to Very Late Stent Thrombosis After New Generation DES Implantation in China

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03491891
Recruitment Status : Completed
First Posted : April 9, 2018
Results First Posted : September 20, 2019
Last Update Posted : September 20, 2019
Sponsor:
Collaborator:
First Affiliated Hospital of Shantou University Medical College
Information provided by (Responsible Party):
First Hospital of Jilin University

Brief Summary:
The investigators sought to identify and verify the potential correlates and mechanisms of Very Late Stent Thrombosis (VLST) after the implantation of new generation drug eluting steng in China from an analysis of multicenter registries.

Condition or disease
Stent Thrombosis

Detailed Description:
This study represents a patient-level pooled analysis of patients undergoing percutaneous coronary intervention with stent implantation for acute coronary syndrome. Multiple aspects including clinical, angiographic, procedural characteristics , intravascular imaging results and blood samples were collected at index PCI and the time of VLST or CAG during follow-up, in order to reveal the potential mechanisms or risk factors that contribute to the development of VLST.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 8476 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Correlates and Mehcanisms Underlying Very Late Stent Thrombosis After Implantation of New Generation DES in China
Actual Study Start Date : January 1, 2014
Actual Primary Completion Date : June 1, 2015
Actual Study Completion Date : June 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Clots

Group/Cohort
derivation cohort
no interventions will be administrated
validation cohort
no interventions will be administrated



Primary Outcome Measures :
  1. Very Late Stent Thrombosis [ Time Frame: Five years ]
    very late stent thrombosis demonstrated by coronary angiography


Biospecimen Retention:   Samples Without DNA
blood samples including serum and plasma


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients>18y,admitted for acute coronary syndrome,successfully underwent PCI with at least one stent, sign informed consent were included.Patients' expected lifetime was less than 1 year for any severe disease(such as tumor,severe respiratory failure et al),and with a surgical plan for important organs within 1 year after surgery and anti-platelet drugs should be discontinued, refusing to sign informed consent, died prior to discharge, unable to participate in regular follow-up were excluded.
Criteria

Inclusion Criteria:

  • Patients>18y,admitted for acute coronary syndrome,successfully underwent PCI with at least one stent, sign informed consent.

Exclusion Criteria:

  • Expected lifetime was less than 1 year for any severe disease(such as tumor,severe respiratory failure et al). There is a surgical plan for important organs within 1 year after surgery and anti-platelet drugs should be discontinued. Refusing to sign informed consent.Died prior to discharge. Poor compliance, unable to participate in regular follow-up.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03491891


Locations
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China, Jilin
Jilin University 1st Hospital
Changchun, Jilin, China, 130021
Sponsors and Collaborators
First Hospital of Jilin University
First Affiliated Hospital of Shantou University Medical College
Investigators
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Study Director: yang zheng Jilin University 1st Hospital Cardiovascular Center

Additional Information:

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Responsible Party: First Hospital of Jilin University
ClinicalTrials.gov Identifier: NCT03491891    
Other Study ID Numbers: wx19871203
First Posted: April 9, 2018    Key Record Dates
Results First Posted: September 20, 2019
Last Update Posted: September 20, 2019
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: When the investigation is completed,we will share it with other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by First Hospital of Jilin University:
Very Late Stent Thrombosis
New generation DES
Additional relevant MeSH terms:
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Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases