Ischemic Heart DiseaseNCT05320926
Clopidogrel Versus Aspirin MOnotherapy After 1- to 3-month of Dual-antiplatelet thErapy Following Zotarolimus-eluting Onyx Stents Implantation; C-MODE Trial
A study testing Clopidogrel monotherapy, Aspirin monotherapy and zotarolimus-eluting stent (Resolute Onyx ®) in people with Ischemic Heart Disease, run by Yonsei University at 1 site in South Korea.
Trial summary
Previous randomized clinical trials have deomonstrated the efficacy and safety of short-term dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI), however, the single antiplatelet agent to be maintained after short-term DAPT was different. Read more about this study
- Who is it for?
- Ages 19 to 84 years
- Conditions the study is for
- Ischemic Heart Disease
- What is being tested?
- Clopidogrel monotherapy, Aspirin monotherapy and zotarolimus-eluting stent (Resolute Onyx ®)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,744 participants
- Where
- 1 siteSouth Korea
- Study dates
- 26 Jul 2022to 10 Jul 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
- Patients ≥19 years
- Patients who received new generation zotarolimus-eluting Onyx stents implantation for treating ischemic heart disease
- Provision of informed consent
Who cannot join
- Age ≥ 85 years
- Acute myocardial infarction
- 2. Left main bifurcation requiring 2-stent technique 3. Pregnant women or women with potential childbearing 4. Life expectancy < 1 year 5. Inability to follow the patient over the period of 1 year after enrollment, as assessed by the investigator 6. Inability to understand or read the informed consent
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
Yonsei University Health System, Severance Hospital
Seoul
Byeong-Keuk Kim, 82-2228-8460, kimbk@yuhs.ac
About this study
Previous randomized clinical trials have deomonstrated the efficacy and safety of short-term dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI), however, the single antiplatelet agent to be maintained after short-term DAPT was different. Therefore, which antiplatelet agent to be maintained after short-term DAPT needs further invstigations.
Read the detailed description
The investigators hypothesized that short-term (1-3 months) DAPT followed by clopidogrel monotherapy will be superior to short-term DAPT followed by aspirin monotherapy after PCI in patients with ischemic heart disease. We will evaluate whether clopidogrel monotherapy will reduce the rate of net adverse clinical events (NACE) at 12 months compared to aspirin monotherapy after very-short term DAPT. Eligible patients will be randomized to short-term DAPT followed by clopidogrel monotherapy or short-term DAPT followed by aspirin monotherapy at hospitalization for index PCI. Randomization will be stratified according to 1) bleeding risk (high bleeding risk [HBR] or non-HBR), 2) clinical presentation (acute coronary syndrome or chronic coronary artery disease), and 3) lesion complexity (non-complex or complex lesion). Regarding the duration of very-short term DAPT, the maintenance duration of DAPT (1-month or 3-month) will be determined as follows:
- If the patients are at HBR (HBR is defined according to ARC-HBR criteria: meeting at least 1 major or 2 minor criteria), 1-month DAPT will be given regardless of clinical presentation or lesion complexity.
- In the patients are at non-HBR, 3-month DAPT will be given in those treated for unstable angina and/or complex lesions (complex lesion is defined as meeting at least one of the following: number of stents implanted ≥3, number of lesions treated ≥3, 3-vessel treated, bifurcation PCI with 2 stents, total stent length ≥60mm, or chronic total occlusion).
- Conditions
- Ischemic Heart Disease
- Being tested
- Clopidogrel monotherapy, Aspirin monotherapy, zotarolimus-eluting stent (Resolute Onyx ®)
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clopidogrel monotherapyDrug
Patients will be randomized to stop aspirin and maintain clopidogrel after short-term DAPT.
Aspirin monotherapyDrug
Patients will be randomized to stop clopidogrel and maintain aspirin after short-term DAPT.
zotarolimus-eluting stent (Resolute Onyx ®)Device
zotarolimus-eluting stent (Resolute Onyx ®)
| Study group | Role | What they receive |
|---|---|---|
| Short-term DAPT followed by clopidogrel monotherapy | Experimental | atients who received zotarolimus-eluting Onyx stents implantation for treating ischemic heart disease at de novo coronary lesion will maintain 1-3 months DAPT. Patients will be randomized to stop aspirin and maintain clopidogrel after DAPT. Receives: Drug: Clopidogrel monotherapy; Device: zotarolimus-eluting stent (Resolute Onyx ®) |
| Short-term DAPT followed by aspirin monotherapy | Active comparator | Arm Description: Patients who received zotarolimus-eluting Onyx stents implantation for treating ischemic heart disease at de novo coronary lesion will maintain 1-3 months DAPT. Patients will be randomized to stop clopidogrel and maintain aspirin after DAPT. Receives: Drug: Aspirin monotherapy; Device: zotarolimus-eluting stent (Resolute Onyx ®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Net adverse clinical events (NACE)
Composite of all-cause death, myocardial infarction, stroke, or major bleeding (BARC 2, 3 or 5)
Measured: 1 year after the procedure
Secondary outcomes (6)
Each component of NACE
Measured: 1 year after the procedure
Major adverse cardiac and cerebrovascular events (MACCE: composite of all-cause death, myocardial infarction, or stroke)
Measured: 1 year after the procedure
Cardiac death
Measured: 1 year after the procedure
Stent thrombosis (definite or probable)
Measured: 1 year after the procedure
Target-vessel revascularization
Measured: 1 year after the procedure
Target-lesion revascularization
Measured: 1 year after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2022
- Study start26 Jul 2022
- Primary completion10 Jul 2028 (estimated)
- Study completion10 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Heart 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
- Masking
- None (open label)
- Enrolment
- 3,744 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, Yonsei University Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05320926
- Sponsor's protocol ID
- 4-2022-0050
- Status last verified
- Oct 2024
- First submitted
- 3 Apr 2022
- Last updated
- 22 Oct 2024
- 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 22 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clopidogrel Versus Aspirin MOnotherapy After 1- to 3-month of Dual-antiplatelet thErapy Following Zotarolimus-eluting Onyx Stents Implantation; C-MODE Trial
- ClinicalTrials.gov ID
- NCT05320926
- Acronym / sponsor ID
- 4-2022-0050
- Conditions
- Ischemic Heart Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3,744 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 26 Jul 2022 (actual)
- Primary completion
- 10 Jul 2028 (estimated)
- Study completion
- 10 Jul 2028 (estimated)
- First posted
- 11 Apr 2022 (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.
Previous randomized clinical trials have deomonstrated the efficacy and safety of short-term dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI), however, the single antiplatelet agent to be maintained after short-term DAPT was different. Therefore, which antiplatelet agent to be maintained after short-term DAPT needs further invstigations.
Detailed description
The investigators hypothesized that short-term (1-3 months) DAPT followed by clopidogrel monotherapy will be superior to short-term DAPT followed by aspirin monotherapy after PCI in patients with ischemic heart disease. We will evaluate whether clopidogrel monotherapy will reduce the rate of net adverse clinical events (NACE) at 12 months compared to aspirin monotherapy after very-short term DAPT. Eligible patients will be randomized to short-term DAPT followed by clopidogrel monotherapy or short-term DAPT followed by aspirin monotherapy at hospitalization for index PCI. Randomization will be stratified according to 1) bleeding risk (high bleeding risk [HBR] or non-HBR), 2) clinical presentation (acute coronary syndrome or chronic coronary artery disease), and 3) lesion complexity (non-complex or complex lesion). Regarding the duration of very-short term DAPT, the maintenance duration of DAPT (1-month or 3-month) will be determined as follows:
- If the patients are at HBR (HBR is defined according to ARC-HBR criteria: meeting at least 1 major or 2 minor criteria), 1-month DAPT will be given regardless of clinical presentation or lesion complexity.
- In the patients are at non-HBR, 3-month DAPT will be given in those treated for unstable angina and/or complex lesions (complex lesion is defined as meeting at least one of the following: number of stents implanted ≥3, number of lesions treated ≥3, 3-vessel treated, bifurcation PCI with 2 stents, total stent length ≥60mm, or chronic total occlusion).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Short-term DAPT followed by clopidogrel monotherapy | Experimental | Drug: Clopidogrel monotherapy, Device: zotarolimus-eluting stent (Resolute Onyx ®)atients who received zotarolimus-eluting Onyx stents implantation for treating ischemic heart disease at de novo coronary lesion will maintain 1-3 months DAPT. Patients will be randomized to stop aspirin and maintain clopidogrel after DAPT. |
| Short-term DAPT followed by aspirin monotherapy | Active comparator | Drug: Aspirin monotherapy, Device: zotarolimus-eluting stent (Resolute Onyx ®)Arm Description: Patients who received zotarolimus-eluting Onyx stents implantation for treating ischemic heart disease at de novo coronary lesion will maintain 1-3 months DAPT. Patients will be randomized to stop clopidogrel and maintain aspirin after DAPT. |
Who may qualify
- Ages
- 19 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients ≥19 years
- Patients who received new generation zotarolimus-eluting Onyx stents implantation for treating ischemic heart disease
- Provision of informed consent
Key exclusion criteria (3 listed)
- Age ≥ 85 years
- Acute myocardial infarction
- 2. Left main bifurcation requiring 2-stent technique 3. Pregnant women or women with potential childbearing 4. Life expectancy < 1 year 5. Inability to follow the patient over the period of 1 year after enrollment, as assessed by the investigator 6. Inability to understand or read the informed consent
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 be randomized to stop aspirin and maintain clopidogrel after short-term DAPT. | Drug | Short-term DAPT followed by clopidogrel monotherapy |
| Aspirin monotherapyPatients will be randomized to stop clopidogrel and maintain aspirin after short-term DAPT. | Drug | Short-term DAPT followed by aspirin monotherapy |
| zotarolimus-eluting stent (Resolute Onyx ®)zotarolimus-eluting stent (Resolute Onyx ®) | Device | Short-term DAPT followed by aspirin monotherapy, Short-term DAPT followed by clopidogrel monotherapy |
Primary outcome
Net adverse clinical events (NACE)
Time frame: 1 year after the procedure
Composite of all-cause death, myocardial infarction, stroke, or major bleeding (BARC 2, 3 or 5)
6 secondary outcomes
Each component of NACE
Time frame: 1 year after the procedure
Major adverse cardiac and cerebrovascular events (MACCE: composite of all-cause death, myocardial infarction, or stroke)
Time frame: 1 year after the procedure
Cardiac death
Time frame: 1 year after the procedure
Stent thrombosis (definite or probable)
Time frame: 1 year after the procedure
Target-vessel revascularization
Time frame: 1 year after the procedure
Target-lesion revascularization
Time frame: 1 year after the procedure
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 22 Oct 2024.
- 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, Yonsei University Health System
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, Aspirin monotherapy and zotarolimus-eluting stent (Resolute Onyx ®) in people with Ischemic Heart 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 3 inclusion and 3 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 22 Oct 2024. 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 (82-2228-8460, kimbk@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Net adverse clinical events (NACE) (time frame: 1 year after the procedure). 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 22 Oct 2024.