Chronic Kidney DiseasesNCT04708587
Appropriate Duration of Anti-Platelet straTegy in Patients With Advance Chronic Kidney Disease After New Generation Drug Eluting Stents (ADAPT-CKD)
A study testing dual anti-platelet therapy at least 6 months and dual anti-platelet therapy 3months or less in people with Chronic Kidney Diseases, run by Yonsei University at 1 site in South Korea.
Trial summary
The purpose of this prospective randomized clinical trial is to compare the clinical outcomes according to the duration of aspirin and clopidogrel or prasugrel with dual anti-platelet therapy after percutaneous coronary intervention in patients with advanced chronic kidney disease using a new generation drug eluting… Read more about this study
- Who is it for?
- Ages 19 to 84 years
- Conditions the study is for
- Chronic Kidney Diseases
- What is being tested?
- dual anti-platelet therapy at least 6 months and dual anti-platelet therapy 3months or less
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- 1 siteSouth Korea
- Study dates
- 23 Mar 2021to 13 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 19 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 19 years old
- Chronic Renal Failure Stage IIIb, IV, V (CKD-EPI eGFR <45 / <30 / <15 or dialysis)
- Patients treated with a new generation drug eluting stent.
- Patients who signed consent form
Who cannot join
- Over 85 years old
- Patients with high risk of bleeding 1) History of hemorrhagic stroke 2) Stroke, dementia or central nervous system damage within 1 year 3) Head trauma or brain surgery within 6 months 4) Tumor in the skull 5) If aortic dissection is suspected 6) Internal bleeding within 6 weeks 7) In case of active bleeding or bleeding disorder 8) In case of major surgery, trauma or bleeding within 3 weeks
- Patients who need oral anticoagulant
- Pregnant women or women of childbearing age
- Life expectancy is less than 1 year
- Patients with a history of intracranial bleeding
- Moderate to severe hepatic impairment (Child-Pugh class B or C)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine
Seoul
Jung-Sun Kim, MD, PhD, FESC, 82)-2)-2228-8457, KJS1218@yuhs.ac
About this study
The purpose of this prospective randomized clinical trial is to compare the clinical outcomes according to the duration of aspirin and clopidogrel or prasugrel with dual anti-platelet therapy after percutaneous coronary intervention in patients with advanced chronic kidney disease using a new generation drug eluting stents.
Read the detailed description
Prospective, open label, multicenter randomized clinical trial
- Conditions
- Chronic Kidney Diseases
- Being tested
- dual anti-platelet therapy at least 6 months, dual anti-platelet therapy 3months or less
- Keywords
- anti-platelet therapy, chronic kidney disease, new generation drug eluting stents
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dual anti-platelet therapy at least 6 monthsDrug
Patients enrolled in dual antiplatelets at least 6 months arm would be administered with aspirin 100mg plus clopidogrel 75mg or prasugrel 10mg once daily for at least 6 months after randomization. Clopidogrel or prasugrel should be maintained after 6 months.
dual anti-platelet therapy 3months or lessDrug
Patient enrolled in the dual antiplatelet therapy less than 3 months arm would be administered with aspirin 100mg plus clopidogrel 75mg or prasugrel 10mg once daily for less than 3 months after randomization. After 3 months clopidogrel or prasugrel should be maintained.
| Study group | Role | What they receive |
|---|---|---|
| dual anti-platelet therapy at least 6 months | Active comparator | Not described Receives: Drug: dual anti-platelet therapy at least 6 months |
| dual anti-platelet therapy 3months or less | Experimental | Not described Receives: Drug: dual anti-platelet therapy 3months or less |
What is being measured
The primary outcome is the main question the study is designed to answer.
Net Clinical adverse event (NACE)
A composite of all cause death, myocardial infarction, stent thrombosis, stroke, major bleeding (BARC 3,5)
Measured: 1 year
Secondary outcomes (12)
The rate of Each component of NACE
all cause death, myocardial infarction, stent thrombosis, stroke, major bleeding (BARC 3,5)
Measured: 1 year
The rate of Cardiovascular death
Measured: 1 year
The rate of Major adverse cardiovascular events (MACE)
A composite of cardiovascular death, myocardial infarction, stent thrombosis or target vessel revascularization
Measured: 1 year
The rate of Composite ischemic outcomes
A composite of cardiovascular death, myocardial infarction, stent thrombosis or ischemic stroke
Measured: 1 year
The rate of major or clinically relevant nonmajor bleeding
BARC type 2,3,5 bleeding
Measured: 1 year
Fatal bleeding
Measured: 1 year
Intracranial hemorrhage
Measured: 1 year
The rate of Target lesion revascularization
Measured: 1 year
The rate of Target vessel revascularization
Measured: 1 year
The rate of Subgroup analysis of primary endpoint, key secondary efficacy, safety endpoint and, revascularization according to the CKD stage (lllb vs. IV or V)
Measured: 1 year
The rate of Subgroup analysis of primary endpoint, key secondary efficacy, safety endpoint and, revascularization according to the clinical presentation (chronic coronary syndrome vs. acute coronary syndrome)
Measured: 1 year
he rate of Subgroup analysis of primary endpoint, key secondary efficacy, safety endpoint and, revascularization according to the type of Stent (polymer-free vs. durable-polymer)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2021
- Study start23 Mar 2021
- Primary completion13 Mar 2027 (estimated)
- Study completion13 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseasesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jung-Sun Kim, MD, PhD, FESC, Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04708587
- Sponsor's protocol ID
- 1-2020-0073
- Status last verified
- Jan 2026
- First submitted
- 31 Dec 2020
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jin IT, Lee SH, Yun KH, Kim W, Shin S, Jang JY, Cho DK, Cha JJ, Kang TS, Lee JH, Cho YK, Heo JH, Ahn SG, Lee J, Lee YJ, Lee SJ, Hong SJ, Ahn CM, Kim BK, Ko YG, Choi D, Hong MK, Jang Y, Kim JS. Optimal antiplatelet strategy in patients with advanced chronic kidney disease undergoing drug-eluting stent implantation: Design and rationale of the randomized ADAPT-CKD trial. Am Heart J. 2026 Aug;298:107437. doi: 10.1016/j.ahj.2026.107437. Epub 2026 Apr 1.
PubMed 41932491
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Appropriate Duration of Anti-Platelet straTegy in Patients With Advance Chronic Kidney Disease After New Generation Drug Eluting Stents (ADAPT-CKD)
- ClinicalTrials.gov ID
- NCT04708587
- Acronym / sponsor ID
- 1-2020-0073
- Conditions
- Chronic Kidney Diseases
- Keywords
- anti-platelet therapy, chronic kidney disease, new generation drug eluting stents
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 23 Mar 2021 (actual)
- Primary completion
- 13 Mar 2027 (estimated)
- Study completion
- 13 Mar 2028 (estimated)
- First posted
- 14 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.
The purpose of this prospective randomized clinical trial is to compare the clinical outcomes according to the duration of aspirin and clopidogrel or prasugrel with dual anti-platelet therapy after percutaneous coronary intervention in patients with advanced chronic kidney disease using a new generation drug eluting stents.
Detailed description
Prospective, open label, multicenter randomized clinical trial
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dual anti-platelet therapy at least 6 months | Active comparator | Drug: dual anti-platelet therapy at least 6 months |
| dual anti-platelet therapy 3months or less | Experimental | Drug: dual anti-platelet therapy 3months or less |
Who may qualify
- Ages
- 19 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Over 19 years old
- Chronic Renal Failure Stage IIIb, IV, V (CKD-EPI eGFR <45 / <30 / <15 or dialysis)
- Patients treated with a new generation drug eluting stent.
- Patients who signed consent form
Key exclusion criteria (7 listed)
- Over 85 years old
- Patients with high risk of bleeding 1) History of hemorrhagic stroke 2) Stroke, dementia or central nervous system damage within 1 year 3) Head trauma or brain surgery within 6 months 4) Tumor in the skull 5) If aortic dissection is suspected 6) Internal bleeding within 6 weeks 7) In case of active bleeding or bleeding disorder 8) In case of major surgery, trauma or bleeding within 3 weeks
- Patients who need oral anticoagulant
- Pregnant women or women of childbearing age
- Life expectancy is less than 1 year
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 |
|---|---|---|
| dual anti-platelet therapy at least 6 monthsPatients enrolled in dual antiplatelets at least 6 months arm would be administered with aspirin 100mg plus clopidogrel 75mg or prasugrel 10mg once daily for at least 6 months after randomization. Clopidogrel or prasugrel should be maintained after 6 months. | Drug | dual anti-platelet therapy at least 6 months |
| dual anti-platelet therapy 3months or lessPatient enrolled in the dual antiplatelet therapy less than 3 months arm would be administered with aspirin 100mg plus clopidogrel 75mg or prasugrel 10mg once daily for less than 3 months after randomization. After 3 months clopidogrel or prasugrel should be maintained. | Drug | dual anti-platelet therapy 3months or less |
Primary outcome
Net Clinical adverse event (NACE)
Time frame: 1 year
A composite of all cause death, myocardial infarction, stent thrombosis, stroke, major bleeding (BARC 3,5)
12 secondary outcomes
The rate of Each component of NACE
Time frame: 1 year
The rate of Cardiovascular death
Time frame: 1 year
The rate of Major adverse cardiovascular events (MACE)
Time frame: 1 year
The rate of Composite ischemic outcomes
Time frame: 1 year
The rate of major or clinically relevant nonmajor bleeding
Time frame: 1 year
Fatal bleeding
Time frame: 1 year
Intracranial hemorrhage
Time frame: 1 year
The rate of Target lesion revascularization
Time frame: 1 year
The rate of Target vessel revascularization
Time frame: 1 year
The rate of Subgroup analysis of primary endpoint, key secondary efficacy, safety endpoint and, revascularization according to the CKD stage (lllb vs. IV or V)
Time frame: 1 year
The rate of Subgroup analysis of primary endpoint, key secondary efficacy, safety endpoint and, revascularization according to the clinical presentation (chronic coronary syndrome vs. acute coronary syndrome)
Time frame: 1 year
he rate of Subgroup analysis of primary endpoint, key secondary efficacy, safety endpoint and, revascularization according to the type of Stent (polymer-free vs. durable-polymer)
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Derived from this study: PubMed 41932491Jin IT, Lee SH, Yun KH, Kim W, Shin S, Jang JY, Cho DK, Cha JJ, Kang TS, Lee JH, Cho YK, Heo JH, Ahn SG, Lee J, Lee YJ, Lee SJ, Hong SJ, Ahn CM, Kim BK, Ko YG, Choi D, Hong MK, Jang Y, Kim JS. Optimal antiplatelet strategy in patients with advanced chronic kidney disease undergoing drug-eluting stent implantation: Design and rationale of the randomized ADAPT-CKD trial. Am Heart J. 2026 Aug;298:107437. doi: 10.1016/j.ahj.2026.107437. Epub 2026 Apr 1.
- Individual participant dataSharing planned: No
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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.
Jung-Sun Kim, MD, PhD, FESC principal investigator
Severance Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dual anti-platelet therapy at least 6 months and dual anti-platelet therapy 3months or less in people with Chronic Kidney Diseases, 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 4 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 21 Jan 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jung-Sun Kim, MD, PhD, FESC (82)-2)-2228-8457, KJS1218@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Net Clinical adverse event (NACE) (time frame: 1 year). 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 NCT04708587, which also lists 1 linked publication.
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 21 Jan 2026.