Stent ThrombosisNCT04715594
CONNECT DES Registrty
An observational study of Stent Thrombosis and Coronary Artery Disease, run by Yonsei University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Stent Thrombosis, Coronary Artery Disease, Stent Stenosis
- What is being tested?
- 1st-generation drug-eluting stent and 2nd-generation drug-eluting stents
- Type of treatment
- Medical device
- How many people
- 350,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- 11 Aug 2019to 1 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Patients who were over 20 years old at the implantation of DES and treated with DES between 1-January-2005 and 31-December-2016
Who cannot join
- Patients who died within 1 week after DES implantation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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:
- 1st-generation vs. 2nd-generation DES
- Durable polymer vs. bioresorbable polymer 2nd-generaion DES
- Ultra-thin strut vs. Conventional strut vs. Thick-strut DES
- According to the type of eluted drugs
- DAPT duration after DES implantation
- Type of anti-platelet therapy after cessation of DAPT
- Intensity of statin therapy after DES implantation
- According to use of nitrate donor or vasodilator after DES implantation
- Use of anti-hypertensive agents after DES implantation
- Use of glucose-lowering agents in diabetic subset of patients
- Conditions
- Stent Thrombosis, Coronary Artery Disease, Stent Stenosis, Myocardial Infarction, Ischemic Heart Disease
- Being tested
- 1st-generation drug-eluting stent, 2nd-generation drug-eluting stents
- Keywords
- coronary artery disease; drug-eluting stents; percutaneous coronary intervention
- Medical subject headings
- Coronary Artery Disease, Myocardial Infarction, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1st-generation drug-eluting stentDevice
Implantation of 1st-generation drug-eluting stent
2nd-generation drug-eluting stentsDevice
Implantation of 2nd-generation drug-eluting stent
| Study group | Role | What they receive |
|---|---|---|
| CONNECT DES Registrty | Not described Receives: Device: 1st-generation drug-eluting stent; Device: 2nd-generation drug-eluting stents |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
Death from any cause
Measured: 5 years
Secondary outcomes (12)
Cardiovascular mortality
Confirmed by death certificate with cardiovascular related diagnosis
Measured: 5 years
Myocardial infarction
Measured: 5 years
Cardiovascular mortality or myocardial infarction
A composite of cardiovascular mortality and myocardial infarction
Measured: 5 years
Ischemic Stroke
Measured: 5 years
Hemorrhagic stroke
Measured: 5 years
Any Stroke
A composite of ischemic stroke and hemorrhagic stroke
Measured: 5 years
Gastrointestinal bleeding
Measured: 5 years
Any bleeding
Any bleeding
Measured: 5 years
Major bleeding
Any bleeding that requires transfusion ≥2 units of red-blood cells, hospitalizaiton, procedure, surgery, or leading to disability or death
Measured: 5 years
Net adverse clinical events (NACE)
A composite of all-cause mortality, recurrent MI, revascularization, ischemic stroke, and major bleeding
Measured: 5 years
Major adverse cardiac events (MACE)
A composite of all-cause mortality, recurrent MI, and revascularization
Measured: 5 years
Major adverse cardiac and cerebrovascular events (MACCE)
A composite of all-cause mortality, recurrent MI, revascularization, and ischemic stroke
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2021
- Study start11 Aug 2019
- Primary completion1 Mar 2021 (estimated)
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Stent ThrombosisStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 350,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Myeong-Ki Hong, Yonsei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04715594
- Sponsor's protocol ID
- 4-2019-0596
- Status last verified
- Jan 2021
- First submitted
- 14 Jan 2021
- Last updated
- 20 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Impossible to share the data due to goverment policy
Publications
Fischman DL, Leon MB, Baim DS, Schatz RA, Savage MP, Penn I, Detre K, Veltri L, Ricci D, Nobuyoshi M, et al. A randomized comparison of coronary-stent placement and balloon angioplasty in the treatment of coronary artery disease. Stent Restenosis Study Investigators. N Engl J Med. 1994 Aug 25;331(8):496-501. doi: 10.1056/NEJM199408253310802.
PubMed 8041414Stettler C, Wandel S, Allemann S, Kastrati A, Morice MC, Schomig A, Pfisterer ME, Stone GW, Leon MB, de Lezo JS, Goy JJ, Park SJ, Sabate M, Suttorp MJ, Kelbaek H, Spaulding C, Menichelli M, Vermeersch P, Dirksen MT, Cervinka P, Petronio AS, Nordmann AJ, Diem P, Meier B, Zwahlen M, Reichenbach S, Trelle S, Windecker S, Juni P. Outcomes associated with drug-eluting and bare-metal stents: a collaborative network meta-analysis. Lancet. 2007 Sep 15;370(9591):937-48. doi: 10.1016/S0140-6736(07)61444-5.
PubMed 17869634Camenzind E, Steg PG, Wijns W. Stent thrombosis late after implantation of first-generation drug-eluting stents: a cause for concern. Circulation. 2007 Mar 20;115(11):1440-55; discussion 1455. doi: 10.1161/CIRCULATIONAHA.106.666800. Epub 2007 Mar 7. No abstract available.
PubMed 17344324Bangalore S, Toklu B, Patel N, Feit F, Stone GW. Newer-Generation Ultrathin Strut Drug-Eluting Stents Versus Older Second-Generation Thicker Strut Drug-Eluting Stents for Coronary Artery Disease. Circulation. 2018 Nov 13;138(20):2216-2226. doi: 10.1161/CIRCULATIONAHA.118.034456.
PubMed 29945934Kim D, Yang PS, Sung JH, Jang E, Yu HT, Kim TH, Uhm JS, Kim JY, Pak HN, Lee MH, Lip GYH, Joung B. Less dementia after catheter ablation for atrial fibrillation: a nationwide cohort study. Eur Heart J. 2020 Dec 14;41(47):4483-4493. doi: 10.1093/eurheartj/ehaa726.
PubMed 33022705Lee SJ, Joo JH, Park S, Kim C, Choi DW, Lee YJ, Hong SJ, Ahn CM, Kim JS, Kim BK, Ko YG, Choi D, Jang Y, Nam CM, Hong MK. Combination therapy with moderate-intensity atorvastatin and ezetimibe vs. high-intensity atorvastatin monotherapy in patients treated with percutaneous coronary intervention in practice: assessing RACING generalizability. Eur Heart J Cardiovasc Pharmacother. 2025 Jan 11;10(8):676-685. doi: 10.1093/ehjcvp/pvad083.
PubMed 37951292Lee SJ, Joo JH, Park S, Kim C, Choi DW, Hong SJ, Ahn CM, Kim JS, Kim BK, Ko YG, Choi D, Jang Y, Nam CM, Hong MK. Combination Lipid-Lowering Therapy in Patients Undergoing Percutaneous Coronary Intervention. J Am Coll Cardiol. 2023 Aug 1;82(5):401-410. doi: 10.1016/j.jacc.2023.05.042.
PubMed 37495276Lee SJ, Choi DW, Kim C, Suh Y, Hong SJ, Ahn CM, Kim JS, Kim BK, Ko YG, Choi D, Park EC, Jang Y, Nam CM, Hong MK. Prolonged dual antiplatelet therapy after drug-eluting stent implantation in patients with diabetes mellitus: A nationwide retrospective cohort study. Front Cardiovasc Med. 2022 Aug 11;9:954704. doi: 10.3389/fcvm.2022.954704. eCollection 2022.
PubMed 36035946Kim C, Choi DW, Lee SJ, Suh Y, Hong SJ, Ahn CM, Kim JS, Kim BK, Ko YG, Choi D, Park EC, Jang Y, Nam CM, Hong MK. Benefit and risk of prolonged dual antiplatelet therapy after drug-eluting stent implantation in patients with chronic kidney disease: A nationwide cohort study. Atherosclerosis. 2022 Jul;352:69-75. doi: 10.1016/j.atherosclerosis.2022.05.019. Epub 2022 Jun 8.
PubMed 35714431Lee SJ, Choi DW, Kim C, Suh Y, Hong SJ, Ahn CM, Kim JS, Kim BK, Ko YG, Choi D, Park EC, Jang Y, Nam CM, Hong MK. Long-Term Beta-Blocker Therapy in Patients With Stable Coronary Artery Disease After Percutaneous Coronary Intervention. Front Cardiovasc Med. 2022 May 17;9:878003. doi: 10.3389/fcvm.2022.878003. eCollection 2022.
PubMed 35656394Lee SJ, Choi DW, Suh Y, Hong SJ, Ahn CM, Kim JS, Kim BK, Ko YG, Choi D, Park EC, Jang Y, Nam CM, Hong MK. Long-Term Clinical Outcomes Between Biodegradable and Durable Polymer Drug-Eluting Stents: A Nationwide Cohort Study. Front Cardiovasc Med. 2022 Apr 29;9:873114. doi: 10.3389/fcvm.2022.873114. eCollection 2022.
PubMed 35571196
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Whole Population-based Study on COreaN NationwidE Claims daTa on Drug-Eluting Stent (CONNECT DES) Registry
- ClinicalTrials.gov ID
- NCT04715594
- Acronym / sponsor ID
- 4-2019-0596
- Conditions
- Stent Thrombosis, Coronary Artery Disease, Stent Stenosis, Myocardial Infarction, Ischemic Heart Disease
- Keywords
- coronary artery disease; drug-eluting stents; percutaneous coronary intervention
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 350,000 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 11 Aug 2019 (actual)
- Primary completion
- 1 Mar 2021 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 20 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 1st-generation vs. 2nd-generation DES
- Durable polymer vs. bioresorbable polymer 2nd-generaion DES
- Ultra-thin strut vs. Conventional strut vs. Thick-strut DES
- According to the type of eluted drugs
- DAPT duration after DES implantation
- Type of anti-platelet therapy after cessation of DAPT
- Intensity of statin therapy after DES implantation
- According to use of nitrate donor or vasodilator after DES implantation
- Use of anti-hypertensive agents after DES implantation
- Use of glucose-lowering agents in diabetic subset of patients
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CONNECT DES Registrty | – | Device: 1st-generation drug-eluting stent, Device: 2nd-generation drug-eluting stents |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- Patients who were over 20 years old at the implantation of DES and treated with DES between 1-January-2005 and 31-December-2016
Key exclusion criteria (1 listed)
- Patients who died within 1 week after DES implantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1st-generation drug-eluting stentImplantation of 1st-generation drug-eluting stent | Device | CONNECT DES Registrty |
| 2nd-generation drug-eluting stentsImplantation of 2nd-generation drug-eluting stent | Device | CONNECT DES Registrty |
Primary outcome
All-cause mortality
Time frame: 5 years
Death from any cause
12 secondary outcomes
Cardiovascular mortality
Time frame: 5 years
Myocardial infarction
Time frame: 5 years
Cardiovascular mortality or myocardial infarction
Time frame: 5 years
Ischemic Stroke
Time frame: 5 years
Hemorrhagic stroke
Time frame: 5 years
Any Stroke
Time frame: 5 years
Gastrointestinal bleeding
Time frame: 5 years
Any bleeding
Time frame: 5 years
Major bleeding
Time frame: 5 years
Net adverse clinical events (NACE)
Time frame: 5 years
Major adverse cardiac events (MACE)
Time frame: 5 years
Major adverse cardiac and cerebrovascular events (MACCE)
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2021.
- Background: PubMed 8041414Fischman DL, Leon MB, Baim DS, Schatz RA, Savage MP, Penn I, Detre K, Veltri L, Ricci D, Nobuyoshi M, et al. A randomized comparison of coronary-stent placement and balloon angioplasty in the treatment of coronary artery disease. Stent Restenosis Study Investigators. N Engl J Med. 1994 Aug 25;331(8):496-501. doi: 10.1056/NEJM199408253310802.
- Background: PubMed 17869634Stettler C, Wandel S, Allemann S, Kastrati A, Morice MC, Schomig A, Pfisterer ME, Stone GW, Leon MB, de Lezo JS, Goy JJ, Park SJ, Sabate M, Suttorp MJ, Kelbaek H, Spaulding C, Menichelli M, Vermeersch P, Dirksen MT, Cervinka P, Petronio AS, Nordmann AJ, Diem P, Meier B, Zwahlen M, Reichenbach S, Trelle S, Windecker S, Juni P. Outcomes associated with drug-eluting and bare-metal stents: a collaborative network meta-analysis. Lancet. 2007 Sep 15;370(9591):937-48. doi: 10.1016/S0140-6736(07)61444-5.
- Background: PubMed 17344324Camenzind E, Steg PG, Wijns W. Stent thrombosis late after implantation of first-generation drug-eluting stents: a cause for concern. Circulation. 2007 Mar 20;115(11):1440-55; discussion 1455. doi: 10.1161/CIRCULATIONAHA.106.666800. Epub 2007 Mar 7. No abstract available.
- Background: PubMed 29945934Bangalore S, Toklu B, Patel N, Feit F, Stone GW. Newer-Generation Ultrathin Strut Drug-Eluting Stents Versus Older Second-Generation Thicker Strut Drug-Eluting Stents for Coronary Artery Disease. Circulation. 2018 Nov 13;138(20):2216-2226. doi: 10.1161/CIRCULATIONAHA.118.034456.
- Background: PubMed 33022705Kim D, Yang PS, Sung JH, Jang E, Yu HT, Kim TH, Uhm JS, Kim JY, Pak HN, Lee MH, Lip GYH, Joung B. Less dementia after catheter ablation for atrial fibrillation: a nationwide cohort study. Eur Heart J. 2020 Dec 14;41(47):4483-4493. doi: 10.1093/eurheartj/ehaa726.
- Derived from this study: PubMed 37951292Lee SJ, Joo JH, Park S, Kim C, Choi DW, Lee YJ, Hong SJ, Ahn CM, Kim JS, Kim BK, Ko YG, Choi D, Jang Y, Nam CM, Hong MK. Combination therapy with moderate-intensity atorvastatin and ezetimibe vs. high-intensity atorvastatin monotherapy in patients treated with percutaneous coronary intervention in practice: assessing RACING generalizability. Eur Heart J Cardiovasc Pharmacother. 2025 Jan 11;10(8):676-685. doi: 10.1093/ehjcvp/pvad083.
- Derived from this study: PubMed 37495276Lee SJ, Joo JH, Park S, Kim C, Choi DW, Hong SJ, Ahn CM, Kim JS, Kim BK, Ko YG, Choi D, Jang Y, Nam CM, Hong MK. Combination Lipid-Lowering Therapy in Patients Undergoing Percutaneous Coronary Intervention. J Am Coll Cardiol. 2023 Aug 1;82(5):401-410. doi: 10.1016/j.jacc.2023.05.042.
- Derived from this study: PubMed 36035946Lee SJ, Choi DW, Kim C, Suh Y, Hong SJ, Ahn CM, Kim JS, Kim BK, Ko YG, Choi D, Park EC, Jang Y, Nam CM, Hong MK. Prolonged dual antiplatelet therapy after drug-eluting stent implantation in patients with diabetes mellitus: A nationwide retrospective cohort study. Front Cardiovasc Med. 2022 Aug 11;9:954704. doi: 10.3389/fcvm.2022.954704. eCollection 2022.
- Derived from this study: PubMed 35714431Kim C, Choi DW, Lee SJ, Suh Y, Hong SJ, Ahn CM, Kim JS, Kim BK, Ko YG, Choi D, Park EC, Jang Y, Nam CM, Hong MK. Benefit and risk of prolonged dual antiplatelet therapy after drug-eluting stent implantation in patients with chronic kidney disease: A nationwide cohort study. Atherosclerosis. 2022 Jul;352:69-75. doi: 10.1016/j.atherosclerosis.2022.05.019. Epub 2022 Jun 8.
- Derived from this study: PubMed 35656394Lee SJ, Choi DW, Kim C, Suh Y, Hong SJ, Ahn CM, Kim JS, Kim BK, Ko YG, Choi D, Park EC, Jang Y, Nam CM, Hong MK. Long-Term Beta-Blocker Therapy in Patients With Stable Coronary Artery Disease After Percutaneous Coronary Intervention. Front Cardiovasc Med. 2022 May 17;9:878003. doi: 10.3389/fcvm.2022.878003. eCollection 2022.
- Derived from this study: PubMed 35571196Lee SJ, Choi DW, Suh Y, Hong SJ, Ahn CM, Kim JS, Kim BK, Ko YG, Choi D, Park EC, Jang Y, Nam CM, Hong MK. Long-Term Clinical Outcomes Between Biodegradable and Durable Polymer Drug-Eluting Stents: A Nationwide Cohort Study. Front Cardiovasc Med. 2022 Apr 29;9:873114. doi: 10.3389/fcvm.2022.873114. eCollection 2022.
- Individual participant dataSharing planned: No. Impossible to share the data due to goverment policy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stent Thrombosis and Coronary Artery Disease, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04715594, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2021.