Discontinuation of Antiplatelet Therapy After Drug-Coated Balloon Treatment
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorUlsan University Hospital
About this trial
The goal of this clinical trial is to evaluate the benefits and risks of discontinuing antiplatelet therapy on clinical outcomes in patients who previously underwent coronary intervention using a drug-coated balloon.
The main questions it aims to answer are:
Does stopping antiplatelet therapy after 12 months affect the risk of net adverse clinical events? Does stopping antiplatelet therapy reduce the risk of bleeding compared with continuing treatment?
Researchers will compare patients who discontinue antiplatelet therapy with patients who continue antiplatelet therapy to determine the impact on clinical outcomes during follow-up.
Participants will:
Be randomly assigned to either discontinue or continue antiplatelet therapy Receive routine clinical follow-up through clinic visits or telephone contacts Be monitored for cardiovascular events and bleeding outcomes over time
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 19 years or older who are able to understand the risks, benefits, and treatment alternatives of the study and who provide written informed consent voluntarily.
Patients who underwent drug-coated balloon treatment at least 12 months prior to enrollment.
Patients who have not experienced major adverse cardiovascular events, including myocardial infarction, stroke, or target vessel revascularization, since the index DCB treatment.
Patients who have not experienced major bleeding since the index DCB treatment.
Disqualifiers
Patients with concomitant vascular disease requiring long-term antiplatelet therapy.
Patients with non-cardiac comorbid conditions that, in the judgment of the investigator, are associated with a life expectancy of less than 1 year or may result in poor compliance with the study protocol.
Patients who are participating in another drug or coronary device clinical study at the time of enrollment.
Trial design
Design model
Parallel
Treatments tested in this trial
Stop Antiplatelet
DrugAntiplatelet discontinuation after DCB treatment
Continue Antiplatelet
DrugAntiplatelet continuation after DCB treatment
Treatment groups
1,042 Participants
are divided into 2 treatment groupsGroup A: Stop AntiplateletExperimental treatment 1 intervention
Group B: Continue AntiplateletActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Net adverse clinical events (NACE)
A composite of all-cause death, non-fatal myocardial infarction, clinically driven target vessel revascularization, and bleeding defined as Bleeding Academic Research Consortium (BARC) type 2 to 5. Non-fatal myocardial infarction is defined as a myocardial infarction diagnosed using standard clinical, electrocardiographic, and biomarker criteria that does not result in death.
Time frame
Up to 12 months after randomizationSecondary outcomes
1
NACE
A composite of all-cause death, non-fatal myocardial infarction, clinically driven target vessel revascularization, and bleeding defined as Bleeding Academic Research Consortium (BARC) type 2 to 5.
Time frame
Up to 24, 36 months after randomization2
The single components of the primary endpoint
A composite of all-cause death, non-fatal myocardial infarction, clinically driven target vessel revascularization, and bleeding defined as Bleeding Academic Research Consortium (BARC) type 2 to 5.
Time frame
Up to 12, 24, 36 months after randomization3
Rate of cardiac death
Cardiac death is defined as death resulting from an immediate cardiac cause, including myocardial infarction, heart failure, fatal arrhythmia, or sudden cardiac death. Deaths of unknown cause or unwitnessed deaths without an identifiable non-cardiac cause are also classified as cardiac death. Deaths clearly attributable to non-cardiac causes, such as malignancy, infection, trauma, or other non-cardiovascular conditions, are not considered cardiac death.
Time frame
Up to 12, 24, 36 months after randomization4
Stroke (ischemic and hemorrhagic)
Stroke is defined as a new, sudden onset of a focal or global neurological deficit lasting 24 hours or longer, or resulting in death, with a vascular cause. Both ischemic stroke and hemorrhagic stroke are included. The diagnosis is confirmed by clinical assessment and supported by brain imaging when available. Transient ischemic attacks (TIA), defined as neurological symptoms resolving within 24 hours without evidence of infarction or hemorrhage, are not considered stroke.
Time frame
Up to 12, 24, 36 months after randomizationSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: