Coronary Artery DiseaseNCT05936606
Tailored Anti-platelet Therapy After DES Implantation in High-risk Patients
A study testing Clopidogrel monotherapy and Tailored anti-platelet therapy in people with Coronary Artery Disease, run by Yonsei University at 1 site in South Korea.
Trial summary
Clopidogrel monotherapy has been found effective in reducing ischaemic cardiovascular and haemorrhagic complications in patients with drug-eluting stent (DES) placement. However, concerns remain about the safety of long-term clopidogrel monotherapy in high-risk patients with HPR (high platelet reactivity) who do not… Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Clopidogrel monotherapy and Tailored anti-platelet therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,434 participants
- Where
- 1 siteSouth Korea
- Study dates
- 16 Aug 2023to May 2029
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients > 18 years old
- Patients who previously underwent percutaneous coronary intervention with drug-eluting stent implantation 12 months (± 3 months) ago.
- At least one high risk characteristics of ischemic events
- High risk patients
- Acute coronary syndrome
- Previous history of cerebrovascular accidents
Show all 20Show fewer
- Previous history of peripheral artery intervention
- Heart failure
- Diabetes mellitus requiring medication
- Chronic kidney disease (regardless of requirement of renal replacement therapy)
- High risk lesions
- Left main disease
- Multivessel disease, 2- or 3- vessels
- Bifurcation lesions requiring 2 or more stents
- Chronic total occlusion
- In-stent restenosis
- Graft lesions
- Diffuse long lesion requiring stent(s) with total stent length ≥28 mm
- Lesion at small sized vessel requiring stent(s) with stent diameter ≤2.5 mm
- Calcified lesions requiring atherectomy
Who cannot join
- Patients > 80 years old
- Pregnant women or women with potential childbearing
- Life expectancy < 1 year
- Refusal or inability to understand of informed consent
- Patients eligible to long-term anticoagulation therapy
- Patients with major bleeding events in previous 3 months before randomization
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
Severance Hospital
Seoul
Byeong-Keuk Kim, 02-2228-8465, kimbk@yuhs.ac
About this study
Official title: A Randomized Comparison of TAILOReD Anti-Platelet Therapy According to Platelet Reactivity Versus Uniform Clopidogrel Monotherapy Beyond 12 Months After Drug-eluting Stent Implantation in High-risk Patients: TAILOR-DAPT
Clopidogrel monotherapy has been found effective in reducing ischaemic cardiovascular and haemorrhagic complications in patients with drug-eluting stent (DES) placement. However, concerns remain about the safety of long-term clopidogrel monotherapy in high-risk patients with HPR (high platelet reactivity) who do not respond adequately to clopidogrel. This study aims to evaluate the effectiveness of a patient-tailored antiplatelet therapy strategy that considers platelet aggregation in high-risk patients with DES placement beyond 12 months after stenting.
Read the detailed description
This study will randomly assign eligible participants who underwent drug-eluting stent placement and have maintained the standard antiplatelet therapy for 12 months to either a control group or an intervention group. The control group will continue receiving clopidogrel monotherapy for 24 months regardless of their PRU (platelet reactivity unit) values. The intervention group will receive personalized antiplatelet therapy based on their PRU values: for non-HPR patients (PRU<208), clopidogrel monotherapy will be continued; for HPR patients (PRU≥208), dual antiplatelet therapy will be prescribed based on clinical diagnosis at the time of stent implantation and individual patients' ischemic/bleeding risk profiles. Patients (≥50 years) who presented with acute myocardial infarction at the time of coronary intervention, and have high-risk characteristics (① ≥65 years ② multi-vessel disease ③ diabetes mellitus ④ chronic kidney disease ⑤ recurrent myocardial infarction) will receive ticagrelor 60 mg twice daily with aspirin, whereas the remainder will receive clopidogrel with aspirin. For high-bleeding-risk patients with two or more major bleeding risk factors according to ARC-HBR, the investigator may consider early discontinuation of dual antiplatelet therapy or de-escalation therapy like aspirin monotherapy based on the patient's risk profile. The treatment assignment ratio is 1:1. The study period will be up to 24 months from the time of randomization.
- Conditions
- Coronary Artery Disease
- Being tested
- Clopidogrel monotherapy, Tailored anti-platelet therapy
- Keywords
- Coronary artery disease, antiplatelet therapy, platelet reactivity
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clopidogrel monotherapyDrug
Patients will receive clopidogrel monotherapy (75 mg qd) for 24 months after randomization, irrespective of PRU value or bleeding risk.
Tailored anti-platelet therapyDrug
In the tailored therapy arm, non-HPR (PRU<208) patients will continue clopidogrel monotherapy until the end of the study at 24 months from randomization, while HPR (PRU≥208) patients will receive dual anti-platelet therapy according to the clinical diagnosis at the time of drug-eluting stent placement: High-risk patients with prior myocardial infarction will receive ticagrelor 60 mg twice daily wiht aspirin 100 mg daily, while the remainder will receive clopidogrel 75 mg daily with aspirin 100 mg daily. For HBR patietns, early cessation of dual antiplatelet therapy or aspirin monotherapy could be considered at the investigator's discretion.
| Study group | Role | What they receive |
|---|---|---|
| Uniform Therapy | Active comparator | Patients will continue clopidogrel monotherapy for 24 months from randomization, irrespective of their PRU measurement. Receives: Drug: Clopidogrel monotherapy |
| Tailored Therapy | Experimental | Patients in the intervention arm will receive tailored anti-platelet therapy according to PRU and bleeding risk Receives: Drug: Tailored anti-platelet therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Net Clinical Adverse Clinical Events (NACE) for 24 months
A composite of all-cause of death, myocardial infarction (MI), stent thrombosis, stroke, or BARC type 2, 3, or 5 bleeding
Measured: upto 2 years after randomization
Secondary outcomes (15)
All-cause death
Measured: upto 2 years after randomization
Cardiovascular death
Measured: upto 2 years after randomization
Myocardial infarction
Measured: upto 2 years after randomization
Stent thrombosis
Measured: upto 2 years after randomization
Ischemia-driven target vessel revascularization
Measured: upto 2 years after randomization
Any revascularization
Measured: upto 2 years after randomization
Stroke
Measured: upto 2 years after randomization
Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding
Measured: upto 2 years after randomization
Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding
Measured: upto 2 years after randomization
Bleeding Academic Research Consortium (BARC) type 2 bleeding
Measured: upto 2 years after randomization
Bleeding Academic Research Consortium (BARC) type 3 bleeding
Measured: upto 2 years after randomization
Bleeding Academic Research Consortium (BARC) type 5 bleeding
Measured: upto 2 years after randomization
All-cause death, myocardial infarction, or stroke
Measured: upto 2 years after randomization
Cardiovascular death, myocardial infarction, stent thrombosis, or stroke
Measured: upto 2 years after randomization
All-cause death, myocardial infarction, stent thrombosis, stroke, or BARC type 3 or 5 bleeding
Measured: upto 2 years after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2023
- Study start16 Aug 2023
- Primary completionMay 2027 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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
- Model description
- Patients will be assigned to receive either standard clopidogrel monotherapy or tailored antiplatelet therapy at 12 months after DES implantation.
- Masking
- None (open label)
- Enrolment
- 3,434 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Byeong-Keuk Kim, Principal investigator, Severance Cardiovascular Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05936606
- Sponsor's protocol ID
- 4-2023-0175
- Status last verified
- Aug 2023
- First submitted
- 22 May 2023
- Last updated
- 30 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Comparison of TAILOReD Anti-Platelet Therapy According to Platelet Reactivity Versus Uniform Clopidogrel Monotherapy Beyond 12 Months After Drug-eluting Stent Implantation in High-risk Patients: TAILOR-DAPT
- ClinicalTrials.gov ID
- NCT05936606
- Acronym / sponsor ID
- 4-2023-0175
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary artery disease, antiplatelet therapy, platelet reactivity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3,434 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 16 Aug 2023 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 10 Jul 2023 (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.
Clopidogrel monotherapy has been found effective in reducing ischaemic cardiovascular and haemorrhagic complications in patients with drug-eluting stent (DES) placement. However, concerns remain about the safety of long-term clopidogrel monotherapy in high-risk patients with HPR (high platelet reactivity) who do not respond adequately to clopidogrel. This study aims to evaluate the effectiveness of a patient-tailored antiplatelet therapy strategy that considers platelet aggregation in high-risk patients with DES placement beyond 12 months after stenting.
Detailed description
This study will randomly assign eligible participants who underwent drug-eluting stent placement and have maintained the standard antiplatelet therapy for 12 months to either a control group or an intervention group. The control group will continue receiving clopidogrel monotherapy for 24 months regardless of their PRU (platelet reactivity unit) values. The intervention group will receive personalized antiplatelet therapy based on their PRU values: for non-HPR patients (PRU<208), clopidogrel monotherapy will be continued; for HPR patients (PRU≥208), dual antiplatelet therapy will be prescribed based on clinical diagnosis at the time of stent implantation and individual patients' ischemic/bleeding risk profiles. Patients (≥50 years) who presented with acute myocardial infarction at the time of coronary intervention, and have high-risk characteristics (① ≥65 years ② multi-vessel disease ③ diabetes mellitus ④ chronic kidney disease ⑤ recurrent myocardial infarction) will receive ticagrelor 60 mg twice daily with aspirin, whereas the remainder will receive clopidogrel with aspirin. For high-bleeding-risk patients with two or more major bleeding risk factors according to ARC-HBR, the investigator may consider early discontinuation of dual antiplatelet therapy or de-escalation therapy like aspirin monotherapy based on the patient's risk profile. The treatment assignment ratio is 1:1. The study period will be up to 24 months from the time of randomization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will be assigned to receive either standard clopidogrel monotherapy or tailored antiplatelet therapy at 12 months after DES implantation.
| Arm | Type | Receives |
|---|---|---|
| Uniform Therapy | Active comparator | Drug: Clopidogrel monotherapyPatients will continue clopidogrel monotherapy for 24 months from randomization, irrespective of their PRU measurement. |
| Tailored Therapy | Experimental | Drug: Tailored anti-platelet therapyPatients in the intervention arm will receive tailored anti-platelet therapy according to PRU and bleeding risk |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Patients > 18 years old
- Patients who previously underwent percutaneous coronary intervention with drug-eluting stent implantation 12 months (± 3 months) ago.
- At least one high risk characteristics of ischemic events
- High risk patients
- Acute coronary syndrome
Key exclusion criteria (6 listed)
- Patients > 80 years old
- Pregnant women or women with potential childbearing
- Life expectancy < 1 year
- Refusal or inability to understand of informed consent
- Patients eligible to long-term anticoagulation therapy
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 |
|---|---|---|
| Clopidogrel monotherapyPatients will receive clopidogrel monotherapy (75 mg qd) for 24 months after randomization, irrespective of PRU value or bleeding risk. | Drug | Uniform Therapy |
| Tailored anti-platelet therapyIn the tailored therapy arm, non-HPR (PRU<208) patients will continue clopidogrel monotherapy until the end of the study at 24 months from randomization, while HPR (PRU≥208) patients will receive dual anti-platelet therapy according to the clinical diagnosis at the time of drug-eluting stent placement: High-risk patients with prior myocardial infarction will receive ticagrelor 60 mg twice daily wiht aspirin 100 mg daily, while the remainder will receive clopidogrel 75 mg daily with aspirin 100 mg daily. For HBR patietns, early cessation of dual antiplatelet therapy or aspirin monotherapy could be considered at the investigator's discretion. | Drug | Tailored Therapy |
Primary outcome
Net Clinical Adverse Clinical Events (NACE) for 24 months
Time frame: upto 2 years after randomization
A composite of all-cause of death, myocardial infarction (MI), stent thrombosis, stroke, or BARC type 2, 3, or 5 bleeding
15 secondary outcomes
All-cause death
Time frame: upto 2 years after randomization
Cardiovascular death
Time frame: upto 2 years after randomization
Myocardial infarction
Time frame: upto 2 years after randomization
Stent thrombosis
Time frame: upto 2 years after randomization
Ischemia-driven target vessel revascularization
Time frame: upto 2 years after randomization
Any revascularization
Time frame: upto 2 years after randomization
Stroke
Time frame: upto 2 years after randomization
Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding
Time frame: upto 2 years after randomization
Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding
Time frame: upto 2 years after randomization
Bleeding Academic Research Consortium (BARC) type 2 bleeding
Time frame: upto 2 years after randomization
Bleeding Academic Research Consortium (BARC) type 3 bleeding
Time frame: upto 2 years after randomization
Bleeding Academic Research Consortium (BARC) type 5 bleeding
Time frame: upto 2 years after randomization
All-cause death, myocardial infarction, or stroke
Time frame: upto 2 years after randomization
Cardiovascular death, myocardial infarction, stent thrombosis, or stroke
Time frame: upto 2 years after randomization
All-cause death, myocardial infarction, stent thrombosis, stroke, or BARC type 3 or 5 bleeding
Time frame: upto 2 years after randomization
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 30 Aug 2023.
- 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.
Byeong-Keuk Kim principal investigator
Severance Cardiovascular 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 Clopidogrel monotherapy and Tailored anti-platelet therapy in people with 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 20 inclusion and 6 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 30 Aug 2023. 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 Byeong-Keuk Kim (02-2228-8465, kimbk@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 Clinical Events (NACE) for 24 months (time frame: upto 2 years after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Aug 2023.