Ignite Creation Date:
2024-05-06 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04715594
Status:
UNKNOWN
Last Update Posted:
2021-01-20
First Post:
2021-01-14
Brief Title:
CONNECT DES Registrty
Sponsor:
Yonsei University
Organization:
Yonsei University
Study Overview
Official Title:
A Whole Population-based Study on COreaN NationwidE Claims daTa on Drug-Eluting Stent CONNECT DES Registry
Status:
UNKNOWN
Status Verified Date:
2021-01
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 971 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
Korea operates national insurance system that covers most of the Koreans 971 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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None