CONNECT DES Registrty

January 14, 2021 updated by: Myeong-Ki Hong, Yonsei University

A Whole Population-based Study on COreaN NationwidE Claims daTa on Drug-Eluting Stent (CONNECT DES) Registry

To date, drug-eluting stents (DES) have become the standard of care in daily practice for the treatment of ischemic heart disease, by overcoming the risk of in-stent restenosis, a major issue raised in the bare-mare stents era. The application of potent anti-proliferative drugs and polymer structures that ensures sustained released of the drugs markedly reduced the neointimal hyperplasia, leading to much improved clinical outcomes compared with bare-metal stents. However, although first-generation sirolimus-eluting stents and paclitaxel-eluting stents significantly reduced the risk of in-stent restenosis and target-vessel revascularization, an augmented risk for very late stent thrombosis and fatal clinical events emerged as a new issue to be solved. Second- and newer- generation DESs adopted innovative stent platforms, novel stent materials, anti-proliferative drugs, and biocompatible polymers (including both durable and bioresorbable). Nowadays, numerous types of DESs (over 20 types) are available in clinical practice as well as bare-metal stents. However, little is known about the clinical outcome according to type of DESs in real-word practice. Given that many of recent randomized clinical trials (RCTs) demonstrate the 'non-inferiority' of brand-new DESs over older DESs in limited period time (usually for 1-year) in a selected patients eligible for RCTs, the real-world clinical outcomes according to type of DES implanted are still unveiled. Although, the question about the differential impact of generation of DES, type of biocompatible polymers (bioresorbable versus durable), thickness of stent struts and type of eluted anti-proliferative drugs are very important in clinical aspect of view, but there is little study conducted on all patients who are actually confronted in daily clinical practice.

Korea operates national insurance system that covers most of the Koreans (97.1%) that are strictly monitored by National Health Insurance Service (NHIS). Of note, the claims database of NHIS of Korea contains all information including the demographic characters of patietns, diagnosis codes (ICD-9 and ICD-10), type of procedures or surgeries and the medical devices utilized, death certificates that contains type of death, and the drugs prescribe in outpatient clinic and hospitals in a individual pill level, that enables monitoring for the drug compliance. This unique feature of NHIS database allows the investigators to gain access to the dose and duration of cardio-protective medications including anti-platelet agents, lipid-lowering agents, anti-hypertensive agents, glucose-lowering agents, nitrate donors, vasodilators, and others. Given the benefits of NHIS database of Korea, we would like to establish a whole-population registry, named as COreaN NationwidE Claims daTa on Drug-Eluting Stent Registry (CONNECT DES Registry). A comprehensive analysis of this data is expected to shed new light on the impact of type of DESs and drug use in real-world practice that could be fully revealed through RCTs.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

According to stringent policy of NHIS database to protect personal information, information regarding type of DES including the thickness of strut, eluted drugs, type of polymer, generation of the DES will be provided after sufficient encryption. Likewise, all information regarding drug prescription, including the total number of pills prescribed during the period, patients' compliance and dosage of drugs will be provided after sufficient encryption. After decrypting the information provided to establish a database suitable for analysis, all eligible patients will be divided into two or more groups according to the type of DES or drug use pattern after DES implantation, which include:

  1. 1st-generation vs. 2nd-generation DES
  2. Durable polymer vs. bioresorbable polymer 2nd-generaion DES
  3. Ultra-thin strut vs. Conventional strut vs. Thick-strut DES
  4. According to the type of eluted drugs
  5. DAPT duration after DES implantation
  6. Type of anti-platelet therapy after cessation of DAPT
  7. Intensity of statin therapy after DES implantation
  8. According to use of nitrate donor or vasodilator after DES implantation
  9. Use of anti-hypertensive agents after DES implantation
  10. Use of glucose-lowering agents in diabetic subset of patients

Study Type

Observational

Enrollment (Anticipated)

350000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Approximately 350,000 patients with DES implantation between 2005 and 2016 would be incorporated in the analyses from National Health Insurance Service (NHIS) database

Description

Inclusion Criteria:

  • Patients who were over 20 years old at the implantation of DES and treated with DES between 1-January-2005 and 31-December-2016

Exclusion Criteria:

  • Patients who died within 1 week after DES implantation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
CONNECT DES Registrty
Device: 1st-generation drug-eluting stent
Implantation of 1st-generation drug-eluting stent
Device: 2nd-generation drug-eluting stents
Implantation of 2nd-generation drug-eluting stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause mortality
Time Frame: 5 years
Death from any cause
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Myocardial infarction
Time Frame: 5 years
5 years
Cardiovascular mortality
Time Frame: 5 years
Confirmed by death certificate with cardiovascular related diagnosis
5 years
Cardiovascular mortality or myocardial infarction
Time Frame: 5 years
A composite of cardiovascular mortality and myocardial infarction
5 years
Ischemic Stroke
Time Frame: 5 years
5 years
Hemorrhagic stroke
Time Frame: 5 years
5 years
Any Stroke
Time Frame: 5 years
A composite of ischemic stroke and hemorrhagic stroke
5 years
Gastrointestinal bleeding
Time Frame: 5 years
5 years
Any bleeding
Time Frame: 5 years
Any bleeding
5 years
Major bleeding
Time Frame: 5 years
Any bleeding that requires transfusion ≥2 units of red-blood cells, hospitalizaiton, procedure, surgery, or leading to disability or death
5 years
Net adverse clinical events (NACE)
Time Frame: 5 years
A composite of all-cause mortality, recurrent MI, revascularization, ischemic stroke, and major bleeding
5 years
Major adverse cardiac events (MACE)
Time Frame: 5 years
A composite of all-cause mortality, recurrent MI, and revascularization
5 years
Major adverse cardiac and cerebrovascular events (MACCE)
Time Frame: 5 years
A composite of all-cause mortality, recurrent MI, revascularization, and ischemic stroke
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 11, 2019

Primary Completion (Anticipated)

March 1, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

January 14, 2021

First Submitted That Met QC Criteria

January 14, 2021

First Posted (Actual)

January 20, 2021

Study Record Updates

Last Update Posted (Actual)

January 20, 2021

Last Update Submitted That Met QC Criteria

January 14, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2019-0596

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Impossible to share the data due to goverment policy

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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